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Updated June 2015 Updated June 2015 India DePuy ASR Hip Recall Resource Packet For the latest information on the ASR Hip Recall, please visit our website at ASRrecall.DePuy.com/India contact DePuy Orthopaedics, Inc.

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Page 1: DePuy ASR Hip Recall Resource Packet - Synthes 38730... · DePuy ASR™ Hip Recall Resource Packet ... tests and/or revision surgical procedure are made out to DePuy Orthopaedics

Updated June 2015Updated June 2015

IndiaDePuy ASR™ Hip Recall

Resource Packet

For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact DePuy Orthopaedics, Inc.

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Contact Information and Additional Resources

India ASR Help Line: 0008 0065 01713 (toll free for TATA subscribers) 0008 0065 00226 (toll free for Airtel subscribers) +91 44 421 44842 (toll number)

The ASR Help Line is a key point of contact for information from DePuy on most ASR recall

questions or concerns.

Additional Resources:

• For Surgeons:

- Dr. Anish Desai, M.D.,FCP, Director Medical Affairs & Clinical Operations,

Johnson & Johnson Medical, India, +91 22 66646602.

• For Patients:

- To register a claim, contact the ASR Help Line at 0008 0065 01713 (toll free for TATA

subscribers), 0008 0065 00226 (toll free for Airtel subscribers), or +91 44 421 44842

(toll number). This call centre will be active from 9.30 am to 6:30 pm, Monday to Friday.

Online Resources:

You can find the most updated materials related to the ASR recall on our website

at ASRrecall.DePuy.com/India

2For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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Table of Contents

2 ......Contact Information

I. Surgeon Information Overview5 ......Summary Guide (DPYUS 63 v2 IN)

6. .....Process Flow for Surgeons (DPYASPAC 38 v1)

II. Identifying and Notifying Patients8 ......Sample Letter for Surgeons to Send to ASR Patients (DPYASPAC 09)

9 ......Sample Letter for Surgeons to Send to Non-ASR Patients (DPY 9)

10 ....Patient Consent Form (DPYASPAC 15)

12 ....Additional Information about the Patient Consent Form (DPYASPAC 22)

13 ....Talking Points for Office Managers (DPYASPAC 85)

III. Patient Education and Registration for Reimbursement of Medical Claims16 ....ASR Information for Patients Handout (DPYASPAC 05 v7)

20 ....ASR Patient Handout on Claims and Reimbursement Process (DPYASPAC 35)

22 ....The ASR Help Line and Crawford Reimbursement Programme (DPYASPAC 86 v6)

IV. Testing and Treatment25 ....ASR Reimbursement Checklist (DPYASPAC 12a v2)

28 ....ASR Hip Patient Treatment Guidelines (DPYUS 25 v 3)

30 ....Guidance on X-Ray, MRI and Ultrasound Testing (DPYASPAC 11)

33 ....ASR Recall Blood Sampling and Shipment Protocol (DPYASPAC 33)

36 ....Letter of Authorisation for Medical Tests (DPYASPAC 17a)

38 ....Surgeon Educational Webcasts

V. Explants40 ....Letter to Surgeons on Explanted Components (DPYASPAC 10)

41 ....Explant Retrieval and Shipping (DPYOUS 65 v1 IN)

44 ....Medical Device Declaration for Shipping (DPYOUS 69 v1 IN)

VI. ASR™ Codes46 ....ASR Codes (DPYUS 20)

Clicking on any of the following text will direct you to the corresponding page in this publication

Look for additional active links throughout

for easier navigation.

Please note: Dates in the footers indicate the last time

that a particular document was updated.

3For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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I. Surgeon Information Overview

4For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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We appreciate that managing the ASRTM Hip System recall in your practice is a complex undertaking, and that you,

your office staff and your patients have many questions about the management of ASR patients, as well as the

reimbursement process.

Overview

• In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from

the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning

the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to

voluntarily recall the ASR Hip System.

• We understand that the August 2010 ASR Hip System recall is concerning for patients, their family members

and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with

the information and support they need.

• DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related

to the recall, including revision surgery if necessary. DePuy will also address recall-related patient out-of-pocket

expenses, such as lost wages and travel costs. ASR patients should contact the ASR Help Line at 0008 0065

01713 (toll free for TATA subscribers), 0008 0065 00226 (toll free for Airtel subscribers), or +91 44 421 44842

(toll number) for assistance.

• All requests for reimbursement of recall-related testing and treatment costs will be reviewed on a case-by-

case basis.

• DePuy’s efforts to support ASR patients and their surgeons remain a top priority. Through the ASR Help Line,

tens of thousands of ASR patients have been assisted worldwide; the program for reimbursing ASR patients

for recall-related expenses is well-established; and DePuy has provided information and support to surgeons

who are treating ASR patients. We encourage ASR patients to visit ASRrecall.DePuy.com/India and contact

the ASR Help Line at 0008 0065 01713 (toll free for TATA subscribers), 0008 0065 00226 (toll free for Airtel

subscribers), or +91 44 421 44842 (toll number) for assistance.

How to Obtain the Information You Need

It is important to note that we are developing materials on a constant basis. Many of these materials are included

in this handbook and all are available on ASRrecall.DePuy.com/India. Please check ASRrecall.DePuy.com/India on a

regular basis for updated materials that may answer the questions you have.

DePuy ASR™ Hip Recall Resource Packet

DPYUS 63 v2 IN 1 March 2013

ASRrecall.

DePuy.com

Click on your region.

Click “Surgeon

Information.”

Documents are located

under “Detailed

Information” and

“Patient Resources.”

Recall Packet

Many important

materials and forms

are included in this

PDF Packet.

Sales

Representative

Updated materials

are available from

your DePuy sales

representative.

Call DePuy

ASR patients

should contact the

ASR Help Line at

0008 0065 01713

(toll free for TATA

subscribers) or

0008 0065 00226

(toll free for Airtel

subscribers) or

+91 44 421 44842

(toll number)

for assistance.

5For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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DPYASPAC 38 v1 31 January 2013

ASR Reimbursement Process Information For Surgeons

IDENTIFICATION• Patient is registered with the ASR Help Line.

• Signed Patient Consent Form and supporting information (e.g. medical records and personal ID document) submitted to ASR Help Line/Puri Crawford.

ASSESSMENT• Patient has consultation with surgeon for assessment of hip implant performance.

• Surgeon determines what testing and/or treatment is required. For resources on testing and treatment, surgeons can refer to the ASR Hip Patient Treatment Guidelines.

CERTIFICATION• Surgeon completes ASR & ASR XL Reimbursement Checklist and sends it to Puri Crawford to confirm

patient has an ASR implant and is undergoing testing and/or treatment.

• If revision surgery is required an estimate of costs is submitted with the checklist.

VALIDATION• Puri Crawford assesses information and either seeks further details or validates data and approves funding

for testing and/or treatment.

FUNDING APPROVAL

• Patient and surgeon notified of approval for funding of revision procedure and provided with letters to authorise healthcare providers to invoice DePuy Orthopaedics Inc. c/o Puri Crawford.

TESTING & TREATMENT

• Patient undergoes tests and/or surgeon performs revision surgery.

CLAIM

• Invoices for the reasonable expenses incurred by the patient, the surgeon and the hospital for the tests and/or revision surgical procedure are made out to DePuy Orthopaedics Inc. and sent to Puri Crawford.

• Patient submits claim for reimbursement of out- of- pocket expenses (e.g. transportation, accommodation)

ASSESSMENT • Puri Crawford assesses claim and either seeks additional information or determines payment amount.

PAYMENT• Payments are made by Puri Crawford on behalf of DePuy. The processing of invoices will be monitored and

payment tracked. Queries regarding the status of payments can be directed to the ASR Help Line. Please ensure you quote the Patient Claim Number as a reference.

6For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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II. Identifying and Notifying Patients

7For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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Date: _________________

Dear _________________

I am writing to share important information about your hip replacement implant, the DePuy

ASR™ Hip System. Some patients with the hip implant you received have experienced

problems that require additional care and potentially further treatment. For this reason,

DePuy Orthopaedics, Inc.(“DePuy”), the maker of your hip, recalled the ASR Hip System and

recommends that patients be evaluated.

Please call my office to schedule an appointment for the evaluation of your hip. During that

appointment, I would like to discuss with you any symptoms/problems you are having, additional

testing that has been recommended and the best plan for ongoing testing and treatment for

you. DePuy will pay for the examination and any medical follow up for the ASR Hip System as

described in the attached Information for Patients sheet. The recall of the ASR Hip does not

necessarily mean you will need to have the implant removed.

The Information for Patients sheet, provided by DePuy, will help to address any questions you

may have about your hip implant, the reason it is being recalled and what you need to do. If you

have any questions regarding the performance of your hip implant, please contact my office. If

you have questions about payment for treatment, please contact DePuy using the phone number

included in the Information for Patients sheet.

Also included with this letter is a Patient Consent Form. Your completion of this form allows me

to share information regarding your hip with DePuy and certain other parties acting on DePuy’s

behalf. DePuy requires this information in order to assess whether you have received one of

the recalled products as well as whether the costs of your medical treatment are eligible for

reimbursement.

Once again, please contact my office as soon as possible to set up a follow up appointment so

that I may address your concerns and discuss the best treatment options for you.

Sincerely,

XXX

Sample Letter for Surgeons to Send to ASR Patients

DPYASPAC 09 1 October 2010

8For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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DPY 9 9 September 2010

Date: _________________

Dear Patient,

As you may know, one of the providers of hip replacement implants recently recalled one type of

hip implant system, the DePuy ASR™ Hip System. I am writing to inform you that the hip implant

I used in your hip surgery was not from the ASR Hip System. You are not affected by this recall

and do not need to take any additional steps as a result of the ASR Hip System recall.

As always, I encourage you to schedule an appointment with me if you are having a problem

with your hip implant.

Sincerely,

XX

Sample Letter from Surgeon Offices for Non-ASR Patients

9For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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Patient Consent Form (For Disclosure of Records)

DePuy ASR™ Hip Resurfacing System and ASR™ XL Acetabular System

Patient Name:  

Patient Address: 

 

Patient Date of Birth:

Information about you and your health is sensitive and confidential and normally will not be disclosed to

anyone outside the hospital without your express consent, or at your request. We recommend that you

ask your Orthopaedic surgeon or General Practitioner to explain the details of this Patient Consent Form

to you before you sign and date the form below.

1. In the context of the DePuy ASR™ Hip Resurfacing System and ASR™ XL Acetabular System (“ASR

Products”), I consent to the following being provided to Johnson & Johnson Private Limited and Puri

Crawford Insurance Surveyors & Loss Assessors India Pvt Ltd (collectively the “Companies”), to assist

with the evaluation and review described below:

i. Copies of all my medical records and x-rays relating to my original ASR Product implant surgery

by [Surgeon’s name]________________________________________________ on/or about

[Date]___________________, to include but not be limited to:

Discharge Summary, physician progress notes; physician orders, operative/procedure records and

reports; emergency room record (if applicable); radiographs; product code and lot number of

components used, and all records relating to the surgery and all follow up visits and records.

ii. Copies of all such medical records and x-rays relating to my subsequent revision surgery by

[Surgeon’s name]____________________________________________ that occurred on/or about

[Date] ________________________.

iii. The ASR hip implant which has been removed, and any tissue samples, will be sent for inspection

and analysis.

2. I understand that the above information and my ASR Product component(s) will be reviewed by oron

behalf of the Companies in order to analyse my experience of and learn more about the ASR Product

and ascertain whether certain costs related to medical treatment associated with the recall of the

ASR Product are eligible for reimbursement.

3. I consent to the Companies using my personal information collected by this review for analysis.

I also consent to this information being collected by or passed to any affiliated entities including

DePuy International Limited of Leeds, UK and DePuy Orthopaedics, Inc. of Warsaw, Indiana, USA,

and any service providers who are working under contract to DePuy International Limited or its

affiliated entities to assist with the evaluation and review described above, or this information may

be provided to regulatory authorities if requested, and all of whom will agree equally to preserve the

confidentiality of the personal information.

DPYASPAC 15 v2 Page 1 of 2 16 February 2015

10For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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I understand that I do not waive my rights to pursue legal action by signing this form or by disclosing this

information.

This form should be returned to:

Johnson & Johnson Private Limited

c/o Puri Crawford Insurance Surveyors & Loss Assessors India Pvt Ltd

No.5, 8th Floor, Jhaver Plaza Building,

1-A, Nungambakkam High Road, Chennai - 600 034

ASR patients should contact the ASR Help Line at 0008 0065 01713 (toll free for TATA subscribers) or

0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll number) for assistance.

Fax Number: +91 (44) 4214 4847

Email: [email protected]

_________________________________________________________ ______________________________________

Signature of Patient Date

If you are signing on behalf of a patient, your signature below evidences your confirmation that you have

the authority to sign this form on behalf of the patient referred to above.

_________________________________________________________ ______________________________________

Signature of Patient’s representative Date

_________________________________________________________

Name of Patient’s representative

_________________________________________________________

Capacity of Patient’s representative

Please note that you have the right to access the personal data held about you. To obtain a copy of the personal

information, please write to Johnson & Johnson Private Limited c/o Puri Crawford Insurance Surveyors & Loss

Assessors India Pvt Ltd, No.5, 8th Floor, Jhaver Plaza Building, 1-A, Nungambakkam High Road, Chennai - 600 034.

We want to make sure your personal information is accurate and up to date. You may therefore ask us to correct or

remove any information you think is inaccurate.

DPYASPAC 15 v2 Page 2 of 2 16 February 2015

11For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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DePuy ASR™ Hip Resurfacing System and ASR™ XL Acetabular System

Additional Information about the Patient Consent Form

DePuy Orthopaedics, Inc. (“DePuy”) would like to address potential questions that surgeons and patients may have

concerning the Patient Consent Form or about providing medical information to DePuy related to the ASR Hip

System recall.

ASR Medical Claims/Reimbursement Centre

DePuy has retained a third party, Puri Crawford Insurance Surveyors & Loss Assessors India Pvt. Ltd. (“Puri

Crawford”), to assist with claims assessment and reimbursement processing and the patient information should be

provided directly to Puri Crawford. Puri Crawford’s address and details are included in the Patient Consent Form.

Role of the Patient Consent Form

The Patient Consent Form is intended to allow surgeons or general practitioners to share patients’ information

regarding medical treatment, with DePuy and Puri Crawford (“Companies”). The Companies require this

information in order to confirm whether patients have received one of the ASR hip products as well as whether

patients are eligible for reimbursement of the costs of medical treatment associated with the ASR recall.

It is important to note that the patient does not waive his/her right to pursue legal action by signing the

Patient Consent Form or by providing the medical information to the Companies. In fact, the Patient

Consent Form expressly notifies patients that they will not be waiving these rights.

Patients should not feel obliged to provide consent and do not need to sign the Patient Consent Form immediately.

If patients decide not to provide consent, the Companies will still endeavour to determine whether patients are

eligible for reimbursement of the cost of medical treatment associated with the ASR recall. However, without access

to the patients’ medical records, the Companies may not be able to confirm that the patient has an ASR implant

and is eligible to be reimbursed, or reimbursement may be delayed.

If patients have any concerns regarding the provision of explanted product components i.e. product which has been

removed, patients may cross out paragraph 1 (iii) of the Patient Consent Form before signing the form. Should the

patient wish to provide the explanted product, this element of the Patient Consent Form can be provided at a later

date. Any explanted products which are supplied for testing will be tested in a non-destructive manner and returned

to the patient’s physician upon request.

Patient health and safety is a top priority for DePuy. We continue to work with hospitals, doctors, patients and

regulators to provide information about the recall and this letter is provided with that aim in mind. If patients have

any questions regarding the Patient Consent Form or are unsure as to whether they should sign this form, they

should talk to their surgeon or general practitioner or consider seeking independent advice.

We encourage ASR patients to visit http://ASRrecall.DePuy.com/India and contact the ASR Help Line at

0008 0065 01713 (toll free for TATA subscribers) or 0008 0065 00226 (toll free for Airtel subscribers) or

+91 44 421 44842 (toll number) for assistance.

Additional Information about the Patient Consent Form

DPYASPAC 22

12For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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• Thank you for calling.

• I understand your concern about this recall.

• I’m sure you have questions about your hip surgery, including what type of hip implant you have,

and I will gladly answer what questions I can, and, if necessary, schedule an appointment for you to

see Dr. XX.

Information about the Recall

• First, let me provide you with some information about the hip implant being recalled:

- There are many different brands of hip implants available.

- The ASR Hip is one of many hip implants available from DePuy Orthopaedics. In August 2010,

DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the

UK National Joint Registry as part of the company’s ongoing surveillance of post-market data

concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best

interests of patients to voluntarily recall the ASR Hip System.

- Globally, the ASR Hip System was first available in July 2003. In India, it was available between

June 2004 and August 2010.

- It is important that ASR patients follow up with their surgeon for evaluation of their hip implant

even if they are not experiencing symptoms.

- DePuy is committed to working with patients to address medical costs directly associated with the

recall. DePuy will also address recall-related patient out-of-pocket expenses, such as lost wages

and travel costs. ASR patients should contact the ASR Help Line at 0008 0065 01713 (toll free for

TATA subscribers) or 0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll

number) for assistance. 

Information about Patient’s Specific Implant

• Now, let’s discuss your specific hip implant.

- [For hospitals and surgeons’ offices who will provide information over the phone:] I need some

personal information from you so I may look up your medical records to determine what type of

hip implant you have. Could you give me your full name, date of birth, and Pan card, Voters ID,

passport, drivers license or ration card [office managers to insert pertinent information needed

for researching medical records]? Thank you. I need some time to look your medical records up,

so please let me know the best phone number to reach you at later today/tomorrow. Once I have

your medical records, then, either the doctor or I will call you back to discuss what hip implant

you have and whether or not we need to schedule a follow-up appointment.

ASR™ Hip System Recall Suggested Talking Points for Office Managers at Hospitals and Surgeons’ Offices

DPYASPAC 85 IN 1 of 2 13 February 2013

13For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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- [For surgeons’ offices who do not provide patient information over the phone:] Due to privacy

concerns, I cannot give patient information over the phone. I can tell you that if you had your hip

surgery before July 2003, your hip implant is not a part of this recall. If your hip surgery was after

July 2003, I can schedule an appointment so you may request your patient information in person.

- [For surgeons’ offices that are sending letters to hip patients about whether or not they are

impacted by this recall:] Dr. XX is sending/has sent a letter to any patient whose hip implant is a

part of this recall; if you receive/have received one of those letters, then you will need to schedule

a follow-up appointment [office managers to adjust talking point based on how the office is

following up with ASR patients and non-ASR patients].

More Information about Recall

• I want to make sure you know where you can find additional information about the recall or speak

to someone in person.

• If you have an internet connection, DePuy has a special section of its website with recall information:

ASRrecall.DePuy.com and ASRrecall.DePuy.com/India

• There’s also an ASR Help Line to answer your questions. For assistance, please contact

0008 0065 01713 (toll free for TATA subscribers) or 0008 0065 00226 (toll free for Airtel subscribers)

or +91 44 421 44842 (toll number)

DPYASPAC 85 IN 2 of 2 13 February 2013

14For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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III. Patient Education and Registration for Reimbursement of Medical Claims

15For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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At DePuy, meeting the needs of patients is at the center of what we do, and everyone at DePuy is united by the

common goal of improving patients’ lives. DePuy puts patients first. If DePuy finds that a product is not meeting its

high standards and the needs of patients, we take appropriate action.

In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK

National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System.

After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System.

We understand that the August 2010 ASR Hip System recall is concerning for patients, their family members

and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the

information and support they need.

What to Do

The ASR XL Acetabular Hip System first became commercially available in India in June 2004. If you had hip surgery

in India prior to June 2004, the hip you received is not subject to this recall. If you had hip surgery after June 2004,

please contact your orthopaedic surgeon or the hospital where your surgery took place to determine whether you

received an ASR Hip.

Next Steps

It may take time for the surgeon or hospital to locate this information for you. For privacy reasons, your orthopaedic

surgeon or the hospital where your surgery took place may ask you to request this information in person.

If you do not have an ASR Hip:

The hip you received is not subject to this recall. Please speak to your orthopaedic surgeon about any questions you

may have about your hip replacement.

If you do have an ASR Hip:

Contact the DePuy ASR Help Line to initiate a claim with DePuy

DePuy is committed to working with patients and their health insurers to address medical costs directly associated

with the recall. DePuy will also address recall-related patient out-of-pocket expenses, such as lost wages and travel

costs. ASR patients should contact the ASR Help Line at 0008 0065 01713 (toll free for TATA subscribers -within

India only) or 0008 0065 00226 (toll free for Airtel subscribers - within India only) or +91 44 421 44842 (toll

number) to initiate the claims process.

Schedule an appointment with your surgeon

If you received the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System, your surgeon will be able

to evaluate how your ASR Hip System is functioning. Additional testing and treatment may be necessary to evaluate

your hip implant.

Follow-up Care

It is important that you follow up with your surgeon, even if you are not experiencing symptoms, for evaluation of

your hip implant. You should discuss with your surgeon how frequently you should return for an office visit if you

are not experiencing symptoms.

ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System Information for Patients

DPYASPAC 05 v7 IN 1 of 4 29 May 2015

16For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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In some cases, your surgeon may order additional blood testing or imaging to evaluate your hip. Your surgeon will

determine the best care plan for you and discuss treatment solutions should they be needed. If you don’t know who

performed your hip replacement surgery, ask your primary care physician or the hospital where the surgery took place.

Testing

Diagnostic Testing may help your surgeon evaluate your hip and determine future treatment recommendations,

if necessary.

What to Expect

Your surgeon may use one or more of several tests to evaluate your ASR Hip System:

X-rays

X-rays will allow your surgeon to evaluate how the ASR Hip System is positioned, if there is any damage to the

bone, and/or if the ASR Hip System has remained attached to the bone. If the X-rays show problems with your ASR

Hip System, your surgeon may recommend additional testing or surgery to replace your hip implant.

Blood Tests

Your surgeon may order blood testing as part of your ASR Hip System evaluation. Your surgeon may recommend a

second blood test to confirm the results of the initial blood test.

MRI or Ultrasound

Your surgeon may want to do an MRI or ultrasound test of your ASR Hip System. Your surgeon may then

recommend additional testing or surgery to replace your implant. 

Treatment

Your surgeon will need to evaluate how your ASR Hip System is functioning and make a decision on the best course

of treatment for your specific needs.

If Your ASR Hip Is Functioning Well

If you do not have any symptoms or test results that suggest you may need to have your implant replaced, then you

should follow your surgeon’s recommendations for continued follow-up.

If Revision Surgery Is Necessary

If you need to have an additional surgery, your surgeon will select the appropriate implant system for you. The

manufacturer and model of any replacement implant system is a choice that you and your doctor are best positioned

to make. DePuy is committed to working with patients to address medical costs directly associated with the recall.

Paying for Testing and Treatment

Your safety and health are important to DePuy, and we are committed to providing ASR patients with the

information and support they need for their recall-related medical care.

DPYASPAC 05 v7 IN 2 of 4 29 May 2015

17For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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DePuy has appointed Super Religare Laboratories (SRL), an independent healthcare services company in India, to

assist your surgeon with tests related to your ASR hip implant. You will not be required to pay for tests related to the

evaluation of your ASR hip implant at SRL.

DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related

to the recall, including revision surgery if necessary. DePuy will also address recall-related patient out-of-pocket

expenses, such as lost wages and travel costs.

DePuy has engaged an independent, third party claims processor, Puri Crawford, so that you may be reimbursed

quickly and efficiently. The reimbursement process offers patients the benefit of highly professional customer

support from a specialized claims-processing company. In order to receive reimbursement for eligible costs

associated with treatment, you will need to register as a claimant by calling the ASR Help Line at 0008 0065 01713

(toll free for TATA subscribers - within India only) or 0008 0065 00226 (toll free for Airtel subscribers - within India

only) or +91 44 421 44842 (toll number). When you call the ASR Help Line, you will be instructed on how to submit

claims for reimbursement.

A Puri Crawford representative will collect basic patient information and will provide the patient with a claim

number. Once the claim is initiated, a Puri Crawford claims adjustor is assigned as a resource for the patient to

address any questions and/or concerns regarding the recall. Patients can contact their Puri Crawford representative

at any time via the ASR Help Line for additional information or to submit expenses.

It is important to note that patients do not waive the right to pursue legal action by initiating a claim for

reimbursement, signing the Patient Consent Form or providing medical information to DePuy.

Reimbursement for Out-of-Pocket Expenses

DePuy will address recall-related patient out-of-pocket expenses, such as lost wages and travel costs. After you

have initiated a claim through the ASR Help Line, please submit any requests for reimbursement for out-of-pocket

expenses and costs you incur associated with receiving treatment to our third party claims processor, Puri Crawford.

Eligible costs for reimbursement may include:

• Medical treatment including testing, treatment, and revision surgery if required

• Travel and hotel expenses related to treatment, if needed

• Lost wages related to missed work associated with treatment

Claims will be evaluated on a case-by-case basis. If eligible, your claim will be processed, and you will be reimbursed

as soon as reasonably practicable.

Programme Dates

For patients who currently have an ASR Hip System implant, Puri Crawford will continue to evaluate requests for

reimbursement of patient out-of-pocket expenses related to medically necessary testing and related exams that are

performed on or before August 24, 2017;

Requests for reimbursement for the cost of a recall-related revision surgery to replace an ASR Hip System implant

and certain patient out-of-pocket expenses will continue to be addressed by Puri Crawford on a case-by-case basis

as long as the revision surgery takes place within 10 years of the initial ASR implantation surgery. As in the past,

DPYASPAC 05 v7 IN 3 of 4 29 May 2015

18For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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DPYASPAC 05 v7 IN 4 of 4 29 May 2015

determinations will be based upon availability of clinical indications showing that the revision is related to the recall.

All medical expenses should continue to be addressed through routine healthcare channels; and

Requests for reimbursement for testing and exams after ASR recall-related revision surgery and associated patient

out-of-pocket expenses will be addressed by Puri Crawford on a case-by-case basis for one year from the date of the

revision surgery.

Additional Programme Information

The reimbursement process offers patients the benefit of highly professional customer support from Puri Crawford,

a specialised claims-processing company. The Puri Crawford reimbursement programme uses common, well-

established claims processes developed specifically to make it easy for patients and health care providers to initiate

claims, submit information and receive reimbursement.

It is important to note that patients do not waive the right to pursue legal action by initiating a claim for

reimbursement, signing the Patient Consent Form or providing medical information to DePuy.

To Submit Claims for Reimbursement and For Additional Questions

Call the ASR Help Line at 0008 0065 01713 (toll free for TATA subscribers - within India only) or 0008 0065 00226

(toll free for Airtel subscribers - within India only) or +91 44 421 44842 (toll number) to obtain a claim number and

to get instructions on how to submit a claim for reimbursement. Please also call the ASR Help Line or visit ASRrecall.

DePuy.com/India with any additional questions you may have.

*Please note: Calls to the toll free ASR Help Line numbers will be free of charge. Outside of operational hours, there

will be an answering service.

19For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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In 2010, DePuy voluntarily recalled the ASR™ XL Acetabular System and DePuy ASR™ Hip

Resurfacing System. We regret the concern that this recall may cause you, but we want you to know

we’re here to help. DePuy is working with your doctor to make sure you have the information you need

to receive the appropriate care.

Your safety and health are important to DePuy. DePuy intends to address reasonable and customary

costs of testing and treatment if you need services, including revision surgery if it is necessary, associated

with the ASR recall.

The recall of the ASR Hip does not necessarily mean you will need to have the hip implant

removed. Many people with ASR hip implants do not experience problems. However, it is important that

you follow up with your surgeon, even if you are not experiencing symptoms, to ensure that your hip is

working well.

Please schedule an appointment with your surgeon as soon as possible so your surgeon can

evaluate how your ASR Hip System is functioning. In some cases, your surgeon may order testing or

imaging to evaluate how your hip is functioning. Your surgeon will determine the best monitoring plan

for you and discuss treatment solutions should they be needed.

Please do not hesitate to contact DePuy if we can help you. If you have any questions or wish

to initiate a reimbursement, please call the ASR Help Line on 0008 0065 01713 (toll free for TATA

subscribers) or 0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll

number). Additional information is available at ASRrecall.Depuy.com/India.

First Steps for Patients with an ASR™ Hip System

Call the ASR Help

Line on 0008 0065

01713 (toll free for

TATA subscribers) or

0008 0065 00226

(toll free for Airtel

subscribers) or

+91 44 421 44842

(toll number) with

questions or to

initiate a claim.

DePuy will request

additional information

so we can determine

if your ASR-related

expenses are eligible

for reimbursement.

Make an appointment

to see your

orthopaedic surgeon

for an evaluation.

Your orthopaedic

surgeon will

determine the best

monitoring and

treatment plan

for you.

DPYASPAC 35 1 of 2 19 November 2010

DePuy would like to share important reimbursement information with you.

Do you have an ASR™ Hip System?

20For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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Reimbursements for eligible expenses issued by the claims processor.

DePuy would like to share important claims and reimbursement information with you.

Do you have an ASR™ Hip System?

You will be asked to provide information about your hip implant and will be given an initial reference number.

Definitions

Claim: Patient record started by DePuy’s claims process to track your expenses and documentation

Claims processor: DePuy has appointed Puri Crawford to manage the ASR Help Line and process claims

relating to the ASR recall

Letter of payment authorisation: Letter to show to providers to confirm that eligible testing and treatment

costs will be covered by DePuy and billed directly to DePuy c/o the claims processor.

Patient consent form: Your health and medical information is private. A medical consent form allows

surgeons/hospitals to share your individually-identifiable health information with DePuy and DePuy’s third party

claims processor in order to process claims

If you have not already signed a Patient Consent Form you will be sent one to sign and return to the ASR Help

Line. This authorises DePuy and the ASR Help Line to access medical records about your hip implant.

We recommend you schedule an appointment with your orthopaedic surgeon to have your implant evaluated.

Your surgeon will fill out a checklist that confirms you have an ASR, that testing or treatment is required and

certain exceptions do not apply. This checklist is sent to the ASR Help Line.

Once it is confirmed you have an ASR implant and are eligible for reimbursement you will be allocated a patient

claim number and sent a letter of payment authorisation to show to providers to confirm that eligible costs will

be addressed by DePuy. Please show this letter to your surgeon and other healthcare providers you see for tests or

treatment.

Submit any out-of-pocket expenses and documentation to the ASR Help Line for review of eligibility.

Contact the ASR Help Line

DPYASPAC 35 2 of 2 19 November 2010

21For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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DPYASPAC 86 v6 IN 1 of 2 29 May 2015

The ASR Help Line and Puri Crawford Reimbursement Programme

To ensure that ASR patient recall-related questions are addressed and eligible out-of-pocket expenses reimbursed

as efficiently as possible, DePuy has engaged Puri Crawford, an independent reimbursements processor, to assist

ASR patients. The reimbursement process offers patients the benefit of highly professional customer support from a

specialised claims-processing company. The Puri Crawford reimbursement programme uses common, well-established

claims processes developed specifically to make it easy for patients and health care providers to initiate claims, submit

information and receive reimbursement. Patients do not waive the right to pursue legal action by participating.

A process focused on the patient’s needs

DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related

to the recall, including revision surgery if necessary. DePuy, through Puri Crawford, will also address recall-related

patient out-of-pocket expenses, such as lost wages and travel costs. Because Puri Crawford specialises in the

complex business of processing medical claims, this reimbursement programme assists patients and health care

providers with information and recall-related reimbursement in a professional, effective and timely fashion.

Using this patient-focused approach, the Crawford Group has assisted tens of thousands of ASR patients

worldwide. To date, thousands of payments have been made to address expenses for testing and treatment, and

patient out-of-pocket expenses, including expenses related to revision surgeries and lost wages for ASR patients.

How the Puri Crawford reimbursement programme assists ASR patients

ASR patients can contact the ASR Help Line at 0008 0065 01713 (toll free for TATA subscribers) or

0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll number) to register a claim.

The process for requesting reimbursement for ASR recall-related expenses is straightforward. First, patients should

register by contacting Puri Crawford and providing patient consent. Once confirmation that the patient has received

an ASR implant is received from either the patient or the patient’s health care provider, recall-related expenses can

be submitted directly to Puri Crawford for review.

A Puri Crawford representative will collect basic patient information and will provide the patient with a

reimbursement number. Once the claim is initiated, a Puri Crawford claims adjustor is assigned as a resource for the

patient to address any questions and/or concerns regarding the reimbursement process. Patients can contact their

Puri Crawford representative at any time via the ASR Help Line for additional information or to submit expenses.

DePuy has asked patients to sign a Patient Consent Form. This form allows healthcare providers to provide

documentation that a patient has received an ASR device. If a particular patient does not wish to sign the Patient

Consent Form or provide the medical information to Puri Crawford, or if DePuy is not able to assess the eligibility of

a patient’s claim for reimbursement, prompt resolution of their claim may not be possible. If a patient does not wish

to sign the Patient Consent Form, the patient may submit verification of claim eligibility to Puri Crawford directly.

Patients do not waive the right to pursue legal action by initiating the process for reimbursement, signing the

Patient Consent Form or providing medical information to Puri Crawford.

Puri Crawford needs medical records to confirm that a patient in fact had an ASR hip implant and to evaluate

whether costs related to the patient’s treatment are eligible for reimbursement.

22For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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Important Programme Dates

DePuy recommends that ASR Hip System patients seek follow-up care according to their doctors’ guidance.

For patients who currently have an ASR Hip System implant, Puri Crawford will continue to evaluate requests for

reimbursement of patient out-of-pocket expenses related to medically necessary testing and related exams that are

performed on or before August 24, 2017;

Requests for reimbursement for the cost of a recall-related revision surgery to replace an ASR Hip System implant

and certain patient out-of-pocket expenses will continue to be addressed by Puri Crawford on a case-by-case basis

as long as the revision surgery takes place within 10 years of the initial ASR implantation surgery. As in the past,

determinations will be based upon availability of clinical indications showing that the revision is related to the recall.

All medical expenses should continue to be addressed through routine healthcare channels; and

Requests for reimbursement for testing and exams after ASR recall-related revision surgery and associated patient

out-of-pocket expenses will be addressed by Puri Crawford on a case-by-case basis for one year from the date of the

revision surgery.

DPYASPAC 86 v6 IN 2 of 2 29 May 2015

23For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

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IV. Testing and Treatment

24For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

contact

24

contact

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DPYASPAC 12a v2 IN 1 of 3 29 May 2015

Please forward the completed form to:

DePuy Orthopaedics Inc.

c/o Puri Crawford & Associates India Pvt. Ltd

No. 5, 8th Floor, Jhaver Plaza Building,

1-A, Nungambakkam High Road, Chennai – 600 034

Tel: [91 (44) 4214 4842]

Fax Number: [91 (44) 4214 4847]

Email: [email protected]

Please note that all fields in section A and B must be completed unless otherwise specified.

Section A: Contact details

Name of surgeon: ___________________________________________________________________________________

Telephone: _____________________________________ Email: ___________________________________________

Name of patient: ____________________________________________________________________________________

Telephone: _____________________________________ (h/p) Mob: _______________________________________

Email/Mailing Address/Fax No of patient (for notification of funding approval): ________________________________

___________________________________________________________________________________________________

Section B: Primary surgery details

Surgeon who performed primary surgery: _______________________________________________________________

Hospital where primary surgery took place: ______________________________________________________________

Date of primary ASR hip replacement/resurfacing surgery:_____/_____/ 20___ a Right a Left a Both

Was this a: a DePuy ASR™ Resurfacing implant a DePuy ASR™ XL implant

Please provide the following information if available:

IMPLANT DETAILS(Primary Surgery) PART Number Size (mm) LOT Number

Femoral Head

Acetabular CUP

Taper SLEEVE

STEM

Please list details of any other components: ______________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

ASR™ & ASR™ XL Hip Systems Reimbursement Checklist

25For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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DPYASPAC 12a v2 IN 2 of 3 29 May 2015

Section C: Testing and Monitoring

Are you planning to monitor this patient annually to assess the performance of their ASR hip? a Yes a No

As part of the testing and monitoring process DePuy are prepared to address reasonable costs associated with X-ray,

Ultrasound, Metal Ion testing and MRI. Are there any other tests you will be requesting as part of the testing and

monitoring process?

If yes, please check (4)details of which tests you will be requesting:

a X-Rays a Right a Left a Both a AP a LAT

a MARS (Metal Artefact Reduction Sequence) MRI

a MRI

a Cobalt blood ion test

a Chromium blood ion test

a Ultrasound (Hip)

a Ultrasound (Pelvis)

Please specify if you would like to recommend any tests in addition to the ones mentioned above: _______________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

Section D: Revision Surgery

Is the patient experiencing symptoms? a Yes a No

If yes, please provide details: __________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

Does the patient require revision surgery? a Yes a No

If YES please answer questions a) b) and c)

a. If the ASR Hip System is the reason for the revision surgery, please explain: ______________________________

_____________________________________________________________________________________________

b. If the ASR Hip System is not the reason, what is the reason for the revision? _____________________________

_____________________________________________________________________________________________

c. Date of Revision Surgery: _____ / _____ / _____ (DD/MM/YY)

Right Left Both

26For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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Revision surgery costs

Please attach an indicative cost for the revision which provides a breakdown of costs using the following as a guide:

Hospital fees (room charges etc), anaesthetist fees, surgeon (and team) fees, implant costs, diagnostic tests (X-ray,

MRI), medication costs, physiotherapy

Surgeries required because of the following reasons will not be covered, subject to review by DePuy. Please check if

any of these apply to this patient:

a size mismatches

a traumatic injury where there is no evidence of soft tissue reaction at the time of surgery

a femoral neck fractures, providing that the fracture occurred within three months of primary surgery, and

subject to review on a case-by-case basis

a where infection is the cause of the revision, as confirmed by positive culture

a primary surgery occurred more than 10 years ago

I hereby declare, to the best of my knowledge, that the information provided above is true in every particular.

_________________________________________________________

Surgeon’s name

_________________________________________________________ ______________________________________

Surgeon’s signature Date

Office use only:

Confirmation of ASR implant Part and Lot numbers:

a DePuy ASR Resurfacing implant

a DePuy ASR XL Implant

IMPLANT DETAILS(Primary Surgery) PART Number LOT Number

Femoral Head

Acetabular CUP

Taper SLEEVE

STEM

Lot Number Femoral Component: ______________________________________________________________________

_________________________________________________________Name of Approver

_________________________________________________________ ______________________________________Signature of Approver Date

DPYASPAC 12a v2 IN 3 of 3 29 May 2015

27For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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ASR Hip Patient Treatment Guidelines

DPYUS 25 v4 Page 1 of 2 1 March 2013

DePuy’s ASR Recall Guide provides guidelines for testing and treatment of ASR Hip patients. DePuy believes that all

patients with a joint replacement be followed up periodically with a frequency determined by local guidance, relevant

physician clinical protocol, and the needs of individual patients. Since the announcement of the ASR recall, guidelines

have been issued in several markets around the world to provide market-specific guidance. These guidance documents

provide important information for surgeons to consider along with their own medical expertise and the needs of

each patient.

Information Resources

This information should be used in conjunction with your normal clinical practice and is not intended to and should

not take the place of your medical judgment or expertise regarding your patients’ treatment.

U.S. Food and Drug Administration

Information for Patients Considering

a Metal-on-Metal Hip Implant System

American Academy of Orthopaedic Surgeons

Questions and Answers

about Metal-on-Metal Implants

2012 Annual Meeting of the American Academy

of Orthopaedic Surgeons: Scientific Exhibit

The Hip Society: Algorithmic Approach

to Diagnosis and Management

of Metal-on-Metal Arthroplasty

U.S. Food and Drug Administration

Information for Surgeons Regarding

Metal-on-Metal Hip Implant Systems

28For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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Radiological and Cross-Sectional Testing Protocols

Guidance for the ASR™ XL Acetabular System/DePuy ASR™ Hip Resurfacing System Recall

In August 2010, DePuy Orthopaedics, Inc. issued a voluntary recall of all ASR products. Since the recall, DePuy has

received inquiries from surgeons concerning how to evaluate patients who received an ASR product. This update is

designed to provide information related to frequently asked questions, and should not preclude any other routine

clinical evaluation or treatment.

We hope this information assists you in the evaluation and treatment of your ASR patients. This information is not

meant to substitute for the exercise of your own medical judgment.

Radiological Protocol Suggestions

1. X-rays should be obtained on an annual basis or as per standard of care

2. All efforts should be in place to have consistency of positioning in each view which could be reliably used to

compare with previous radiographic exams in order to assess any radiographic changes since the original procedure.

3. Views for plain x-rays:

a. AP-Pelvis (centered at symphysis pubis)

b. AP-Hip (at hip joint center)

c. Cross table lateral

4. If using digital radiographs, it is recommended to have the image size at 1:1 to facilitate any linear dimension

analysis.

5. Radiographic signs of interest:

While we encourage you to familiarise yourself with the available medical literature on the subject, our current

understanding of potential radiographic signs of interest discussed in the literature is as follows:

• Interface implant-bone demarcations

• Periprosthetic osteolysis lesion(s)

• Femoral neck narrowing (resurfacing)

• Acetabulum inclination angle subtended by a horizontal reference line delineated by interobturator line

tangent to inferior aspect of both obturator foramen and a line through the open face of the acetabulum.

• Hip joint center relative to vertical line through tear-drop and a horizontal reference line, i.e. intraobturator line.

• Acetabulum coverage (superior-lateral and inferior-medial)

• Visible changes from previous radiographs

Additional Cross-sectional Imaging Suggestions

Magnetic Resonance Imaging (MRI)

MRIs should be ordered as MRI with metal artifact reduction sequences (MARS) to reduce the size and intensity of

magnetic field distortion created by the implant

Patient Position

Supine, feet first

Position pelvis in the centre of body matrix coil (top of prosthesis at top of coil)

Landmark at centre of coil

Guidance on X-Ray, MRI and Ultrasound Testing

DPYASPAC 11 1 of 3 8 November 2010

30For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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Machine Settings

Machine settings are specific to each MRI scanner. The manufacturer of the MRI scanner should be

contacted to identify the appropriate settings for the metal artifact reduction sequence (MARS). The

MARS order provided by the surgeon to radiology should include – “MARS fast spin echo” or “MARS

turbo spin echo” to reduce artifacts.

MRI Findings

MRI findings should be correlated with clinical examination. MRI may demonstrate changes that appear to

correspond to macroscopic surgical findings (soft-tissue necrosis, abnormal masses, sterile fluid collections

and bone necrosis).

MRI Signs of Interest

While we encourage you to familiarise yourself with the available medical literature on

the subject, our current understanding of potential MRI signs of interest discussed in the

literature is as follows:

• Periprosthetic soft tissue mass with no hyperintense T2W fluid signal or fluid-filled peri-prosthetic

cavity

• Peri-prosthetic soft tissue mass/fluid-filled cavity or lesions with either of following:

- Muscle atrophy (fatty infiltration) or oedema in any muscle other than short external rotators or

- Bone marrow oedema: hyperintense on short inversion recovery sequence (STIR)

- Fluid-filled cavity extending through deep fascia

• Tendon defect and/or avulsion, intermediate T1W soft tissue cortical or marrow signal

Fluid collections are usually well circumscribed and best seen on T2-weighted sequences. Cores have signal

intensities similar to that of bladder fluid, while the pseudocapsules appear hypointense to skeletal muscle and often

feature areas of no signal.

Soft-tissue masses are more solid and best seen on a T2-weighted sequence. They may appear less circumscribed than

the fluid collections and may have no obvious capsule and can characterise loss of muscle definition and tissue planes.

Ultrasound

Ultrasound can be used when a MARS MRI is not available. Ultrasound should be performed by staff experienced

in conducting musculoskeletal ultrasound scans. Ultrasound findings should be correlated with clinical examination;

these may demonstrate changes that appear to correspond to macroscopic surgical findings (soft-tissue swelling,

abnormal masses, fluid collections, muscle or tendon abnormalities and bone necrosis).

Patient Position

Supine and lateral decubitus

Probe Placement

To obtain sagittal oblique images place probe parallel to long axis of femoral neck.

To obtain additional images, place probe anteriorly, posteriorly and directly laterally to femoral neck.

DPYASPAC 11 2 of 3 8 November 2010

31For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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Ultrasound Findings

Any abnormality needs to be examined in multiple planes. Examination includes inspection of the psoas

muscle. Use probes of varying frequency depending on the size of the patient.

Ultrasound Signs of Interest

While we encourage you to familiarise yourself with the available medical literature on the

subject, our current understanding of potential ultrasound signs of interest discussed in the

literature is as follows:

• Extra-articular fluid collection

• Fluid collections (identified as hypoechoic areas in soft tissues)

• Solid or cystic masses

These suggestions are based on the attached published literature references. These articles provide more information

related to the MARS MRI and ultrasound techniques and the findings related to soft tissue reactions around

hip replacements. Medical practice is constantly evolving, so there may be new suggestions regarding imaging

techniques in the future. If you have additional questions, please contact Dr. Anish Desai, M.D.,FCP, Director Medical

Affairs & Clinical Operations, Johnson & Johnson Medical, India, +91 22 66646602.

References 1. CT and MRI of hip arthroplasty. J.G. Cahira, A.P. Toms, T.J. Marshall, J. Wimhurst, J. Nolan; Clinical Radiology, 2007; 62:1163-1171.

2. Optimization of metal artifact reduction (MAR) sequences for MRI of total hip prostheses. A.P. Toms, C. Smith-Bateman, P.N. Malcolm, J. Cahir, M. Graves; Clinical Radiology. 2010; 65:447–452.

3. The imaging spectrum of peri-articular inflammatory masses following metal-on-metal hip resurfacing. Christopher. S. J. Fang, Paul Harvie, Christopher L. M. H. Gibbons, Duncan Whitwell, Nicholas A. Athanasou, Simon Ostlere; Skeletal Radiol. 2008; 37:715–722.

4. The painful metal-on-metal hip resurfacing; A. J. Hart, S. Sabah, J. Henckel, A. Lewis, J. Cobb, B. Sampson, A. Mitchell, J. A. Skinner J Bone Joint Surg [Br] 2009;91-B:738-44.

5. “Asymptomatic” Pseudotumors After Metal-on-Metal Hip Resurfacing Arthroplasty Prevalence and Metal Ion Study; Young-Min Kwon, Simon J. Ostlere, Peter McLardy-Smith, Nicholas A. Athanasou, Harinderjit S. Gill, and David W. Murray, MD; The Journal of Arthroplasty, 2010.

6. Metal-on-metal hip resurfacings—a radiological perspective; Zhongbo Chen, Hemant Pandit, Adrian Taylor, Harinderjit Gill, David Murray, Simon Ostlere; European Society of Radiology, 2010.

7. Grading the severity of soft tissue changes associated with metal-on-metal hip replacements: reliability of an MR grading system. Helen Anderson, Andoni Paul Toms, John G. Cahir, Richard W. Goodwin, James Wimhurst, John F. Nolan; Skeletal Radiol Published online July 2010.

8. Magnetic Resonance Imaging Findings in Painful Metal-On-Metal Hips: A Prospective Study. Shiraz A. Sabah, Adam W.M. Mitchell, Johann Henckel, Ann Sandison, John A. Skinner, and Alister J. Hart, The Journal of Arthroplasty, 2010 [epub ahead of print].

9. Metal Artifact Reduction Sequence: Early Clinical Applications. Randall V. Olsen, Peter L. Munk, Mark J. Lee, DennisL. Janzen, Alex L. MacKay, Qing-San Xiang, Bassam Masri; RadioGraphics 2000; 20:699–712

10. Magnetic Resonance Imaging in the Diagnosis and Management of Hip Pain After Total Hip Arthroplasty. H. John Cooper, Amar S. Ranawat, Hollis G. Potter, Li Foong Foo, Shari T. Jawetz, Chitranjan S. Ranawat; The Journal of Arthroplasty. 2009; (5):661-67.

11. A Consensus Paper on Metal Ions in Metal-on-Metal Hip Arthroplasties. Steven J. MacDonald, Wolfram Brodner, Joshua J. Jacobs; The Journal of Arthroplasty 2004; 19(8) Suppl. 3: 12-16.

DPYASPAC 11 3 of 3 8 November 2010

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This document includes details relating to blood sampling, shipping and transportation guidelines connected to the

ASR Recall:

To support blood testing DePuy Orthopaedics Inc. (“DePuy”) has contracted the SAS Trace Element Laboratories at

Charing Cross Hospital (London, UK) and Southampton General Hospital (UK) to provide a centralised resource for

this service and will make arrangements with a shipping agent to transport the samples. To facilitate comprehensive,

efficient claims handling and reimbursement of medical and associated costs, DePuy has partnered with Puri

Crawford, a global claims management organisation. In India, DePuy India has also partnered with Super Religare

Laboratories (SRL) to provide surgeons of ASR patients in India with local facilities to undertake diagnostic tests of

patients with ASR implants.

Payment

For any ASR blood sample shipments and testing ordered in accordance with this Protocol, the shipping agent and

analytical laboratory will invoice DePuy and the costs will be met directly by DePuy. There will be no cost payable by

the hospital/clinic to the shipping agent or the analytical laboratory for this service.

Please note, all phlebotomy kits and blood samples tubes should be sourced and paid for directly by the hospital/ clinic.

Claims for reimbursement of the cost of this equipment can be submitted via the medical reimbursement process.

To enable DePuy to provide this service there are a few steps that need to be followed, these are detailed below.

Step 1. Contact the ASR Help Line

Contact the ASR Help Line operated by DePuy’s representative, Puri Crawford, on 0008 0065 01713 (toll free for

TATA subscribers) or 0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll number) to obtain

your patient’s medical claim number. If your patient has not yet registered with the ASR Help Line, this will need to

be done before a medical claim/reimbursement number can be allocated.

You will need to identify the sample with the patient claim number in order for the ASR Help Line and the analytical

laboratory to process the collection and testing of the blood sample.

Step 2. Blood Sampling Procedure

The blood sampling procedure outlined below in this document is based on the following guidance that was

released jointly by the British Hip Society and the British Orthopaedic Association on 22nd April 2010:

‘Chromium and cobalt and other metals present in surgical implants are usually measured by inductively coupled

plasma mass spectrometry (ICPMS) using either quadruple (QICPMS) or high resolution mass spectrometry (HR-

ICPMS). Both are capable of accurate analysis, but only HRI-CPMS instruments will allow the measurement of some

other metal ions such as titanium and nickel. Electro thermal atomisation atomic absorption spectrometry may also

be used, but is less common now in the leading trace element analysis laboratories. Blood samples for trace element

analysis must be collected in trace element free tubes. Tubes are available with either EDTA anticoagulant for the

analysis of whole blood samples or with no additive for the analysis of serum samples. There is a small difference in

results obtained from whole blood and serum, but both can be used to assess release of metals from implants. The

primary advantage of whole blood for the surgeon is that samples can be sent to the laboratory without the need

for separation of serum, a step which may allow the potential for sample contamination. Some laboratories may

ASR Recall Blood Sampling and Shipment Protocol

DPYASPAC 33a IN 1 of 3 October 2014

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advise against the use of stainless steel needles for sample collection, but the amount of contamination introduced

via this route is usually low relative to the amount of chromium and cobalt released from high wear joints.’

Procedure:

Trace element free tubes can be sourced from numerous suppliers such as local hospital pathology laboratories, or

national suppliers such as:

Becton-Dickinson:

6ml BD Vacutainer® K2-EDTA tube with Royal Blue BD Hemogard™ Closure, catalogue number 368381

Or

7ml BD Vacutainer® Na-Hep tube with Royal Blue BD Hemogard™ Closure, catalogue number 369735

Sarstedt:

S-Monovette 7.5ml for Trace Metals, product code number 01.1604.400

Greiner:

6ml (Na Hep) Trace Element Tube, Royal Blue cap, part number 456080

To further minimise the likelihood of contamination from a stainless steel needle, an initial 10ml of blood should

be withdrawn and discarded to avoid any potential contamination from blood that may have been in touch with

the metal needle tip. A further sample of blood, the volume of which depends on the size of tube available for

storage, should be drawn into the trace element free tube. In most instances 6ml of blood should be sufficient for

a complete blood analysis. The actual volume required for laboratory analysis is in the region of 50 micro-litres,

however the larger volume of 6 - 7.5 millilitres (ml) is required during handling to make processing possible.

The sample must be labelled with key information; in particular it must contain the patient’s:

• Name

• Date of birth

• Patient Claim Number

• Name and location of hospital/clinic

• Name of surgeon

• Date implantation of the ASR™ or ASR™ XL hip system occurred

• Date of sample collection

Step 3. Arrange blood test collection

Contact the ASR Help Line at 0008 0065 01713 (toll free for TATA subscribers) or 0008 0065 00226 (toll free for

Airtel subscribers) or +91 44 421 44842 (toll number) to set up an appointment at a Super Religare Laboratories

(SRL) location (or to arrange collection of the blood sample(s) by the shipping agent, in rare circumstances of home

pickup). You can telephone and provide the following details over the phone or fill in the attached form and fax or

email it to the ASR Help Line.

DPYASPAC 33a IN 2 of 3 October 2014

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DPYASPAC 33a IN 3 of 3 October 2014

You will be required to provide the following information:

• Contact name

• Contact telephone number

• Number of samples to be collected

• How the samples will be presented for collection (e.g. glass vials, plastic vials, size of vial etc). This is so the

shipping agent can ensure the correct size of external packaging will be available when they collect the samples.

• Patient name

• Patient Claim Number

• Collection site address (in rare circumstances of home pickup of blood sample)

Step 4. Blood test sample collection and shipping protocol

Blood test sample collection may be done at the nearest SRL laboratory or via home collection, in rare circumstances.

Upon collection, blood samples will be packaged and shipped at ambient temperature. The shipping agent will

provide all necessary packaging and transportation for shipping the samples. They will collect the samples directly

from the SRL laboratory clinic and transport them using validated packaging and shipping protocols to either the

SRL Mumbai laboratory for analysis, or the SAS Trace Element Laboratories at Charing Cross Hospital (London, UK)

or Southampton General Hospital (UK).

Please be advised the ASR Help Line will require at least 2-3 days’ notice to meet your preferred collection date.

Step 5. Blood sample results

The analytical laboratory will report the blood test results back to the recipient of the results whose details were

provided in accordance with step 3.

For any additional questions with regard to the blood sampling or shipping procedure please contact:

Dr. Anish Desai, M.D.,FCP

Director, Medical Affairs & Clinical Operations

Johnson & Johnson Medical

India

+91 22 66646602.

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(insert date)

To Whom It May Concern:

Re: Medical Tests for: (insert name of patient)

ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System

Please be advised that DePuy Orthopaedics, Inc., (“DePuy”) the provider of the ASR™ XL Acetabular System and

DePuy ASR Hip Resurfacing System, has voluntarily recalled these implants.

The above named patient has one of the recalled implants in one or both hips. This letter is to confirm that DePuy will

cover the reasonable and customary costs of annual medical consultations and any of the following diagnostic tests

associated with assessing the performance of their ASR implant as recommended by their physician. The requested

diagnostic tests to be performed for (insert patient name) at the SRL diagnostic laboratory are indicated below.

Conduct

those tests

ticked

Test Code Test Name

CU0107 Cobalt Blood

CU0108 Chromium Blood

CU0109 X-ray  HIP (AP)

CU0128 X-ray  HIP (Lateral)

CU0131 X-ray  HIP (Right)    

CU0132 X-ray  HIP (Left)     

CU0139 X-Ray Pelvis with BOTH HIPS

CU0112 MARS MRI

CU0140 MRI PELVIS PLAIN

CU0129 Ultrasound - Pelvis 

CU0130 Ultrasound - HIPS (Both)

CU0133 USG - HIP  (Right)      

CU0134 USG - HIP (Left)       

CU0135 CT Scan - Pelvis Plain

CU0137 CT Scan - HIP PLAIN  

CU0145 COBALT COLLECTION (Samples to be collected by Biocair)

CU0146 CHROMIUM COLLECTION (Samples to be collected by Biocair)

To facilitate comprehensive, efficient claims handling and reimbursement DePuy has partnered with our organisation,

Puri Crawford Insurance Surveyors & Loss Assessors India Pvt. Ltd, a claims management organisation. Please therefore

forward your invoices for the tests to Puri Crawford at the address below. In order for these invoices to be eligible for

reimbursement you will need to provide a copy of this form with your invoice and cite the following Patient Claim

Number: (insert patient claim number) on the invoice itself and all associated correspondence.

Letter of Authorisation for Medical Tests

DPYASPAC 17a 1 of 2 24 April 2012

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Send all invoices and correspondence to:

DePuy Orthopaedics, Inc.

C/o Puri Crawford Insurance Surveyors & Loss Assessors India Pvt. Ltd

No.5, 8th Floor, Jhaver Plaza Building,

1-A, Nungambakkam High Road,

Chennai - 600 034

If you have any questions please contact us on the ASR Help Line at 0008 0065 01713 (toll free for TATA

subscribers) or 0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll number).

Yours faithfully,

(insert authorised signatory name),

For Puri Crawford Insurance Surveyors & Loss Assessors India Pvt. Ltd

DPYASPAC 17a 2 of 2 24 April 2012

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Surgeon Educational Webcasts

DePuy has hosted educational Webcasts for surgeons who manage the care of ASR patients.

You can access the Webcasts anytime using the links below:

Optimized MRI Including Metal Artifact Reduction Sequence

Evaluation and Treatment of Patients with ASR-XL Implants

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V. Explants

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ASR™ XL Acetabular System/DePuy ASR™ Hip Resurfacing System: Retention of Explanted Components

Attention Doctors and Hospital Representatives:

In the event that you are revising an ASR implant and your patient has consented for their explants to be

provided to DePuy Orthopaedics, Inc. we request your assistance in retaining explanted DePuy ASR and

ASR XL Hip System components and related tissue samples.

When a femoral hip stem is removed during the revision of ASR XL components, please retain the hip stem

with the ASR components. If the revision procedure requires removal of tissue adjacent to the ASR Hip

System, samples of the removed tissue should be retained for inspection in addition to the hip stem and

ASR components. The samples of the removed tissue should be obtained by routine procedures. The total

sample volume should not be larger than a golf ball in size and should only be taken from tissue removed

from areas adjacent to the revised implant that may contain debris from the subject device. Collection and

inspection of explanted components and tissue samples require prior written patient authorisation.

DePuy has identified a third-party retrieval laboratory to receive and analyse explanted components and

related tissue samples. Please retain these items in accordance with the following procedures until DePuy

can arrange for their transport to the appropriate retrieval laboratory:

1. Preservation: All tissue samples should be placed in fixative and explanted components should be

decontaminated in accordance with hospital procedures.

2. Packaging: After decontamination, place each component in a separate zip top style bag and

then place all the components for the patient in one larger zip top style bag. Tissue samples should

remain soaked in the fixative and retained in a leak-proof container marked as “biohazard” and

“hazardous” per hospital procedures for the fixative.

3. Tracking: For tracking purposes, all retrieved components and tissue samples should be labelled

either directly on the bag/bottle or on a tag firmly attached to the bag/bottle with the patient name,

patient date of birth, hospital name, surgeon name, hospital patient identity number, date of original

surgery and date of revision surgery. When available, the DePuy supplied complaint number, which is

prefaced by the letters WPC or DINT, should also be included.

Thank you for your assistance in retaining explanted components and tissue samples. If you have

any questions, please contact T. Dhivakar at Puri Crawford at [email protected] or

0008 0065 01713 (toll free for TATA subscribers) or 0008 0065 00226 (toll free for Airtel subscribers) or

+91 44 421 44842 (toll number).

Letter to Surgeons on Explanted Components

DPYASPAC 10 v1 20 February 2013

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Procedure for Shipping of Retrieved DePuy ASR™ or ASR™ XL Components from the Hospital or Healthcare Centre to the Contract Laboratory

1. PURPOSE:

The following is DePuy’s protocol for giving instruction to outside parties for the preservation,

tracking, storage, and shipping processes for retrieved DePuy ASR or ASR XL components and

possible tissue sample(s).

2. SCOPE:

2.1 This procedure only applies to all devices and possible tissue sample(s) that are retrieved

during the revision surgery for DePuy ASR or ASR XL components.

2.2 Shipment of DePuy devices that do not involve the revision of DePuy ASR or ASR XL

components are to be handled in the customary manner.

A validly signed and completed patient authorisation/consent form (DPYOUS 13,

DPYASPAC 15 or equivalent) must be provided in order for any devices or tissue samples to

be transferred to the retrieval laboratory under this protocol.

3. PRECAUTIONS:

3.1 Only personnel trained in handling and shipping infectious substances shall perform this

procedure.

3.2 Standard precautions for biological materials must be used when handling the retrieved

components and possible tissue samples.

4. DECONTAMINATION OF EXPLANTS AND PRESERVATION OF TISSUE SAMPLES:

4.1 Following the completion of local hospital decontamination protocols

or

immersion in 10% formalin for a minimum of 12 hours, all explants and tissue samples

should be prepared for collection and shipping to the London Implant Retrieval Centre in one

of the following ways:

4.1.1 Any liquid should be disposed of and then ideally each individual prosthesis should be

wrapped in tissue or gauze

4.1.2 A small amount of water should be added to the 10% formalin solution to dilute it

to <10%

4.1.3 Any formalin in excess of 30ml should be poured away so that volume is <30ml.

4.2 Please note that due to shipping regulations explants or tissue samples packed with ≥10%

formalin in volumes ≥30ml will not be collected.

4.3 Explants and tissue samples should be packed separately in a suitable pot, box or pouch.

This is to limit any damage that could be caused in transit should more than one explanted

prosthesis be packed together.

Explant Retrieval and Shipping

DPYOUS 65 v1 IN Page 1 of 3 28 March 2013

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5. PACKAGING AND PAPERWORK FOR SHIPPING:

5.1 After decontamination and fixating any tissue, place each component in a separate container

and then all components together for that patient’s hip device in one larger container (i.e.

one large container per hip device). Depending upon the method of decontamination, zip

top style bags for each component may be suitable containers.

5.2 A copy of the attached DPYOUS 69 v1 IN “Used Medical Device Declaration for Shipping”

shall be used to record the following information. A patient label may be affixed to the form

to provide the information and the remaining information completed by hand:

5.2.1 Patient’s name;

5.2.2 Patient’s date of birth (DOB);

5.2.3 DePuy Reimbursement ID (eClaim number)

5.2.4 Hospital’s patient identity number;

5.2.5 Hospital or healthcare center’s name;

5.2.6 Surgeon’s name;

5.2.7 Date of original surgery;

5.2.8 Date of revision surgery;

5.2.9 and, if it is available, the DePuy DINT number.

5.3 The attached DPYOUS 69 v1 IN “Used Medical Device Declaration for Shipping” form shall

be used to record the tracking information requested above and firmly attached to the bag

containing any retrieved components or tissue samples for that patient.

5.4 If the tissue sample is retained in a separate container, then a copy of the DPYOUS 69 v1 IN

“Used Medical Device Declaration for Shipping” form shall be affixed to this container as well.

6. STORAGE:

6.1 The retrieved components and possible tissue samples should be stored in a secured location

until collected by the explant shipping service.

7. REQUIREMENTS BEFORE SHIPPING:

7.1 The hospital health care professional must have obtained the patient’s written authorisation/

consent (DPYOUS 13, DPYASPAC 15 or equivalent) for the disclosure of information for the

evaluation of the retrieved components. Retain a copy of the signed authorisation/consent

with the retrieved components at all times.

8. SHIPPING ARRANGEMENT

8.1 Where a patient has consented to the explants being transferred to DePuy you

should contact Puri Crawford at 0008 0065 01713 (toll free for TATA subscribers) or

0008 0065 00226 (toll free for Airtel subscribers) or +91 44 421 44842 (toll number), who

will arrange to collect and transport the explants to a third-party retrieval laboratory who will

receive and analyse explanted components and related tissue samples.

DPYOUS 65 v1 IN Page 2 of 3 28 March 2013

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9. CHECKLIST OF ITEMS TO SHIP:

9.1 Retrieved components;

9.2 Tissue sample(s), if available;

9.3 DPYOUS 69 v1 IN”Used Medical Device Declaration for Shipping” form;

9.4 A copy of the signed Patient Consent Form.

10. PACKING THE ITEMS FOR SHIPMENT:

10.1 The shipping agent will collect and pack for shipping the containers holding the components

and samples.

11. CONTACT DETAILS :

If you have any questions please contact:

T. Dhivakar – TEAM LEADER

Claims Management Services

Puri Crawford Insurance Surveyors & Loss Assessors India Pvt. Ltd

No. 5, 8th Floor, Jhaver Plaza Building, 1-A, Nungambakkam High Road, Chennai 600034

ASR Help Line:

0008 0065 01713 (toll free for TATA subscribers-within India only)

0008 0065 00226 (toll free for Airtel subscribers- within India only)

+91 44 421 44842 (toll number-outside India)

(ASR Help Line will be active from 9.30 am - 6.30 pm, Monday to Friday)

12. EXTERNAL DOCUMENTS:

12.1 DPYOUS 69 v1 IN Used Medical Device Declaration for Shipping

DPYOUS 65 v1 IN Page 3 of 3 28 March 2013

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This form applies to all devices and possible tissue samples that are retrieved during the revision surgery

for DePuy ASR™ or ASR™ XL components.

A validly signed and completed copy of the Patient Consent Form (DPYOUS 13, DPYASPAC 15 or equivalent) must

be included with this form, confirm: a YES

DePuy DINT number (if available): ______________________________________________________________________

Patient’s name: ______________________________________________________________________________________

Patient’s date of birth (DOB): __________________________________________________________________________

DePuy Reimbursement ID (eClaim number): ______________________________________________________________

Hospital’s patient identity number: _____________________________________________________________________

Hospital or healthcare centre’s name: ___________________________________________________________________

Surgeon’s name: ____________________________________________________________________________________

Date of original surgery: ______________________________________________________________________________

Date of revision surgery: ______________________________________________________________________________

This shipment contains the following used medical devices:

Device Name Implant Identification Markings

Possible Presence

of Pathogen

a YES a NO

a YES a NO

a YES a NO

a YES a NO

a YES a NO

a YES a NO

Tissue Sample: a YES a NO Tissue Origin: ___________________________________________________

Possible Presence of Pathogen: a YES a NO

_________________________________________________________ ______________________________________

Signature of Hospital Representative Date

_________________________________________________________Print Name and Title

Please include this form with the components.

DPYOUS 69 v1 IN Page 1 of 1 28 March 2013

Used Medical Device Declaration for Shipping

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VI. ASR Codes

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US codes510(k) ClearedPart Number US 510k Description510k ASR Acetabular Cups 9998‐00‐744 ASR ACETABULAR IMPLANT 449998‐00‐746 ASR ACETABULAR IMPLANT 469998‐00‐748 ASR ACETABULAR IMPLANT 489998‐00‐750 ASR ACETABULAR IMPLANT 509998‐00‐752 ASR ACETABULAR IMPLANT 529998‐00‐754 ASR ACETABULAR IMPLANT 549998‐00‐756 ASR ACETABULAR IMPLANT 569998‐00‐758 ASR ACETABULAR IMPLANT 589998‐00‐760 ASR ACETABULAR IMPLANT 609998‐00‐762 ASR ACETABULAR IMPLANT 62999805764 TOTAL ASR ACET IMP SIZE 64999805966 TOTAL ASR ACET IMP SIZE 66999806168 TOTAL ASR ACET IMP SIZE 68999806370 TOTAL ASR ACET IMP SIZE 70510k ASR femoral primary heads (aka hemis) 9998‐90‐039 ASR FEMORAL IMPLANT SIZE 399998‐90‐041 ASR FEMORAL IMPLANT SIZE 419998‐90‐043 ASR FEMORAL IMPLANT SIZE 439998‐90‐045 ASR FEMORAL IMPLANT SIZE 459998‐90‐046 ASR FEMORAL IMPLANT SIZE 469998‐90‐047 ASR FEMORAL IMPLANT SIZE 479998‐90‐047 ASR FEMORAL IMPLANT SIZE 479998‐90‐049 ASR FEMORAL IMPLANT SIZE 499998‐90‐051 ASR FEMORAL IMPLANT SIZE 519998‐90‐053 ASR FEMORAL IMPLANT SIZE 539998‐90‐055 ASR FEMORAL IMPLANT SIZE 559998‐90‐057 ASR FEMORAL IMPLANT SIZE 579998‐90‐059 ASR FEMORAL IMPLANT SIZE 599998‐90‐061 ASR FEMORAL IMPLANT SIZE 619998‐90‐063 ASR FEMORAL IMPLANT SIZE 63510k ASR fem XL modular heads  9998‐90‐239 ASR UNI FEMORAL IMPL SIZE 399998‐90‐241 ASR UNI FEMORAL IMPL SIZE 419998‐90‐243 ASR UNI FEMORAL IMPL SIZE 439998‐90‐245 ASR UNI FEMORAL IMPL SIZE 459998‐90‐246 ASR UNI FEMORAL IMPL SIZE 469998‐90‐247 ASR UNI FEMORAL IMPL SIZE 479998‐90‐249 ASR UNI FEMORAL IMPL SIZE 499998‐90‐251 ASR UNI FEMORAL IMPL SIZE 519998‐90‐253 ASR UNI FEMORAL IMPL SIZE 539998‐90‐255 ASR UNI FEMORAL IMPL SIZE 55999890157 ASR UNI FEMORAL IMPL SIZE 57999890159 ASR UNI FEMORAL IMPL SIZE 59999890161 ASR UNI FEMORAL IMPL SIZE 61999890163 ASR UNI FEMORAL IMPL SIZE 63

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

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US codes510(k) ClearedPart Number US 510k DescriptionAdapter Sleeves9998‐90‐340 ASR TAP SLV ADAP 11/13 +0 9998‐90‐343 ASR TAP SLV ADAP 11/13 +3 9998‐90‐346 ASR TAP SLV ADAP 11/13 +6 9998‐90‐349 ASR TAP SLV ADAP 11/13 +9 9998‐00‐312 ASR TAP SLV ADAP 12/14 +2 9998‐00‐315 ASR TAP SLV ADAP 12/14 +5 9998‐90‐333 ASR TAP SLV ADAP 11/13 ‐39998‐90‐353 ASR TAP SLV ADAP 12/14 ‐19998‐00‐318 ASR TAP SLV ADAP 12/14 +8 

510k ASR fem XL Anatomic modular heads and tapers (same Int)  999899025 ASR XLA SML Sleeve 11/13 ‐3999899035 ASR XLA SML Sleeve 11/13 +0999899045 ASR XLA SML Sleeve 11/13 +3999899055 ASR XLA SML Sleeve 11/13 +6999899019 ASR XLA SML Sleeve 11/13 +9999899029 ASR XLA STD Sleeve 11/13 ‐3999899039 ASR XLA STD Sleeve 11/13 +0999899049 ASR XLA STD Sleeve 11/13 +3999899049 ASR XLA STD Sleeve 11/13 +3999899059 ASR XLA STD Sleeve 11/13 +6999899069 ASR XLA STD Sleeve 11/13 +9

510k ASR 300 Cups (same as Int)999830744 ASR 300 Size 44999830746 ASR 300 Size 46999830748 ASR 300 Size 48999830750 ASR 300 Size 50999830752 ASR 300 Size 52999830754 ASR 300 Size 54999830756 ASR 300 Size 56999830758 ASR 300 Size 58999830760 ASR 300 Size 60999830762 ASR 300 Size 62999830764 ASR 300 Size 64999830766 ASR 300 Size 66999830768 ASR 300 Size 68999830770 ASR 300 Size 70

Additional Codes999800764 ASR ACETABULAR CUPS 64999800766 ASR ACETABULAR CUPS 66

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

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US codes510(k) ClearedPart Number US 510k Description999800768 ASR ACETABULAR CUPS 68999800770 ASR ACETABULAR CUPS 70999890257 ASR UNI FEMORAL IMPL SIZE 57999890259 ASR UNI FEMORAL IMPL SIZE 59999890261 ASR UNI FEMORAL IMPL SIZE 61999890263 ASR UNI FEMORAL IMPL SIZE 63999800139 ASR UNI FEMORAL IMPL SIZE 39999800141 ASR UNI FEMORAL IMPL SIZE 41999800143 ASR UNI FEMORAL IMPL SIZE 43999800145 ASR UNI FEMORAL IMPL SIZE 45999800146 ASR UNI FEMORAL IMPL SIZE 46999800147 ASR UNI FEMORAL IMPL SIZE 47999800149 ASR UNI FEMORAL IMPL SIZE 49999800151 ASR UNI FEMORAL IMPL SIZE 51999800153 ASR UNI FEMORAL IMPL SIZE 53999800155 ASR UNI FEMORAL IMPL SIZE 55

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

48For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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US codesIDE Study (In progress)Part Number US IDE DescriptionIDE/PMA ASR Acetabular Cups 9998‐00‐044 TOTAL ASR ACET IMP SIZE 449998‐00‐046 TOTAL ASR ACET IMP SIZE 469998‐00‐048 TOTAL ASR ACET IMP SIZE 489998‐00‐050 TOTAL ASR ACET IMP SIZE 509998‐00‐052 TOTAL ASR ACET IMP SIZE 529998‐00‐054 TOTAL ASR ACET IMP SIZE 549998‐00‐056 TOTAL ASR ACET IMP SIZE 569998‐00‐058 TOTAL ASR ACET IMP SIZE 589998‐00‐060 TOTAL ASR ACET IMP SIZE 609998‐00‐062 TOTAL ASR ACET IMP SIZE 629998‐00‐064 TOTAL ASR ACET IMP SIZE 649998‐00‐066 TOTAL ASR ACET IMP SIZE 669998‐00‐068 TOTAL ASR ACET IMP SIZE 689998‐00‐070 TOTAL ASR ACET IMP SIZE 70IDE ASR femoral heads ‐ obsolete9998‐01‐532 TOTAL ASR FEM IMP SIZE 399998‐01‐534 TOTAL ASR FEM IMP SIZE 419998‐01‐536 TOTAL ASR FEM IMP SIZE 439998‐01‐538 TOTAL ASR FEM IMP SIZE 459998‐01‐539 TOTAL ASR FEM IMP SIZE 469998‐01‐540 TOTAL ASR FEM IMP SIZE 479998‐01‐540 TOTAL ASR FEM IMP SIZE 479998‐01‐542 TOTAL ASR FEM IMP SIZE 499998‐01‐544 TOTAL ASR FEM IMP SIZE 519998‐01‐546 TOTAL ASR FEM IMP SIZE 539998‐01‐548 TOTAL ASR FEM IMP SIZE 559998‐01‐550 TOTAL ASR FEM IMP SIZE 579998‐01‐552 TOTAL ASR FEM IMP SIZE 599998‐01‐554 TOTAL ASR FEM IMP SIZE 619998‐01‐556 TOTAL ASR FEM IMP SIZE 63PMA ASR femoral heads 9998‐03‐039 TOTAL ASR FEM IMP SIZE 399998‐03‐041 TOTAL ASR FEM IMP SIZE 419998‐03‐043 TOTAL ASR FEM IMP SIZE 439998‐03‐045 TOTAL ASR FEM IMP SIZE 459998‐03‐046 TOTAL ASR FEM IMP SIZE 469998‐03‐047 TOTAL ASR FEM IMP SIZE 479998‐03‐049 TOTAL ASR FEM IMP SIZE 499998‐03‐051 TOTAL ASR FEM IMP SIZE 519998‐03‐053 TOTAL ASR FEM IMP SIZE 539998‐03‐055 TOTAL ASR FEM IMP SIZE 559998‐03‐057 TOTAL ASR FEM IMP SIZE 579998‐03‐059 TOTAL ASR FEM IMP SIZE 599998‐03‐061 TOTAL ASR FEM IMP SIZE 619998‐03‐063 TOTAL ASR FEM IMP SIZE 63

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

49For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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International CodesInternational Part Number Commercial DescriptionInternational ASR Acetabular Cups 999803944 TOTAL ASR ACET IMP SIZE 44999804146 TOTAL ASR ACET IMP SIZE 46999804348 TOTAL ASR ACET IMP SIZE 48999804550 TOTAL ASR ACET IMP SIZE 50999804652 TOTAL ASR ACET IMP SIZE 52999804754 TOTAL ASR ACET IMP SIZE 54999804956 TOTAL ASR ACET IMP SIZE 56999805158 TOTAL ASR ACET IMP SIZE 58999805360 TOTAL ASR ACET IMP SIZE 60999805562 TOTAL ASR ACET IMP SIZE 62999805764 TOTAL ASR ACET IMP SIZE 64999805966 TOTAL ASR ACET IMP SIZE 66999806168 TOTAL ASR ACET IMP SIZE 68999806370 TOTAL ASR ACET IMP SIZE 70International ASR femoral primary heads999803239 TOTAL ASR FEM IMP SIZE 39999803441 TOTAL ASR FEM IMP SIZE 41999803643 TOTAL ASR FEM IMP SIZE 43999803845 TOTAL ASR FEM IMP SIZE 45999803946 TOTAL ASR FEM IMP SIZE 46999804047 TOTAL ASR FEM IMP SIZE 47999804047 TOTAL ASR FEM IMP SIZE 47999804249 TOTAL ASR FEM IMP SIZE 49999804451 TOTAL ASR FEM IMP SIZE 51999804653 TOTAL ASR FEM IMP SIZE 53999804855 TOTAL ASR FEM IMP SIZE 55999805057 TOTAL ASR FEM IMP SIZE 57999805359 TOTAL ASR FEM IMP SIZE 59999805561 TOTAL ASR FEM IMP SIZE 61999805763 TOTAL ASR FEM IMP SIZE 63International ASR fem modular XL heads999890139 ASR UNI FEMORAL IMPL SIZE 39999890141 ASR UNI FEMORAL IMPL SIZE 41999890143 ASR UNI FEMORAL IMPL SIZE 43999890145 ASR UNI FEMORAL IMPL SIZE 45999890146 ASR UNI FEMORAL IMPL SIZE 46999890147 ASR UNI FEMORAL IMPL SIZE 47999890149 ASR UNI FEMORAL IMPL SIZE 49999890151 ASR UNI FEMORAL IMPL SIZE 51999890153 ASR UNI FEMORAL IMPL SIZE 53999890155 ASR UNI FEMORAL IMPL SIZE 55999890157 ASR UNI FEMORAL IMPL SIZE 57999890159 ASR UNI FEMORAL IMPL SIZE 59999890161 ASR UNI FEMORAL IMPL SIZE 61999890163 ASR UNI FEMORAL IMPL SIZE 63

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

50For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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International CodesInternational Part Number Commercial Description

999800200 ASR TAP SLV ADAP 11/13 +0 999800203 ASR TAP SLV ADAP 11/13 +3 999800206 ASR TAP SLV ADAP 11/13 +6 999800209 ASR TAP SLV ADAP 11/13 +9 999800102 ASR TAP SLV ADAP 12/14 +2 999800105 ASR TAP SLV ADAP 12/14 +5 999800300 ASR TAP SLV ADAP 9/10 0999800303 ASR TAP SLV ADAP 9/10 +3999800313 ASR TAP SLV ADAP 9/10 ‐3999800201 ASR TAP SLV ADAP 11/13‐3999800207 ASR TAP SLV ADAP 12/14 ‐1999800108 ASR TAP SLV ADAP 12/14 +8 

999899039 ASR XL Anatomic Head Size 39999899041 ASR XL Anatomic Head Size 41999899043 ASR XL Anatomic Head Size 43999899045 ASR XL Anatomic Head Size 45999899046 ASR XL Anatomic Head Size 46999899047 ASR XL Anatomic Head Size 47999899049 ASR XL Anatomic Head Size 49999899051 ASR XL Anatomic Head Size 51999899051 ASR XL Anatomic Head Size 51999899053 ASR XL Anatomic Head Size 53999899055 ASR XL Anatomic Head Size 55999899057 ASR XL Anatomic Head Size 57999899059 ASR XL Anatomic Head Size 59999899061 ASR XL Anatomic Head Size 61999899063 ASR XL Anatomic Head Size 63

999899018 ASR XLA +8 Sleeve 12/14 ‐3.5999899028 ASR XLA +8 Sleeve 12/14 ‐1999899038 ASR XLA +8 Sleeve 12/14 +2999899048 ASR XLA +8 Sleeve 12/14 +5999899058 ASR XLA +8 Sleeve 12/14 +8999899014 ASR XLA +4 Sleeve 12/14 ‐3.5999899024 ASR XLA +4 Sleeve 12/14 ‐1999899034 ASR XLA +4 Sleeve 12/14 +2999899044 ASR XLA +4 Sleeve 12/14 +5999899054 ASR XLA +4 Sleeve 12/14 +8

510k ASR 300 cups (same as US)  999830744 ASR 300 Size 44999830746 ASR 300 Size 46999830748 ASR 300 Size 48

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

51For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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International CodesInternational Part Number Commercial Description999830750 ASR 300 Size 50999830752 ASR 300 Size 52999830754 ASR 300 Size 54999830756 ASR 300 Size 56999830758 ASR 300 Size 58999830760 ASR 300 Size 60999830762 ASR 300 Size 62999830764 ASR 300 Size 64999830766 ASR 300 Size 66999830768 ASR 300 Size 68999830770 ASR 300 Size 70

Additional  International Codes999800238 Modular Femoral Head 38999800240 Modular Femoral Head 40999800242 Modular Femoral Head 42999800244 Modular Femoral Head 44999800245 Modular Femoral Head 45999800246 Modular Femoral Head 46999800248 Modular Femoral Head 48999800250 Modular Femoral Head 50999800252 Modular Femoral Head 52999800252 Modular Femoral Head 52999800254 Modular Femoral Head 54999800256 Modular Femoral Head 56999800258 Modular Femoral Head 58999800260 Modular Femoral Head 60999800262 Modular Femoral Head 62

256688236 ASR Total Femoral Implant Size 55 RSA256688371 ASR Total Femoral Implant Size 49 RSA256688402 ASR Total Femoral Implant Size 57 RSA256688495 ASR Total Femoral Implant Size 47 RSA256688628 ASR Total Femoral Implant Size 51 RSA256688799 ASR Total Femoral Implant Size 53 RSA812899170 ASR Total Acetabular Implant RSA Size 54812899207 ASR Total Acetabular Implant RSA Size 54812899226 ASR Total Acetabular Implant RSA Size 54812899337 ASR Total Acetabular Implant RSA Size 54812899456 ASR Total Acetabular Implant RSA Size 54812899532 ASR Total Acetabular Implant RSA Size 54

Additional codes999800046 ASR ACETABULAR IMPLANT 46999800048  ASR ACETABULAR IMPLANT 48999800050 ASR ACETABULAR IMPLANT 50

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

52For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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International codesInternationalPart Number Commercial Description999800052 ASR ACETABULAR IMPLANT 52999800054 ASR ACETABULAR IMPLANT 54999800056 ASR ACETABULAR IMPLANT 56999800058 ASR ACETABULAR IMPLANT 58999800060 ASR ACETABULAR IMPLANT 60999800062 ASR ACETABULAR IMPLANT 62999800064 ASR ACETABULAR IMPLANT 64999800066 ASR ACETABULAR IMPLANT 66999800068 ASR ACETABULAR IMPLANT 68999801534 TOTAL ASR FEM IMP SIZE  41999801536 TOTAL ASR FEM IMP SIZE  43999801538 TOTAL ASR FEM IMP SIZE  45999801540 TOTAL ASR FEM IMP SIZE  47999801542 TOTAL ASR FEM IMP SIZE  49999801544 TOTAL ASR FEM IMP SIZE  51999801546 TOTAL ASR FEM IMP SIZE  53999801548 TOTAL ASR FEM IMP SIZE  55999801550 TOTAL ASR FEM IMP SIZE  57999801552 TOTAL ASR FEM IMP SIZE  59999801554 TOTAL ASR FEM IMP SIZE  61

DPYUS 20 19 October 2011

ASR Hip System Recall Part Code Listing

53For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com/India

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