COPYRIGHT © 2004 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED

Increasing Patient Safety and Orthopaedic Device

Quality via Adverse Event Reporting Mechanisms

BY MICHAEL TANNER, MS, AND GLORIA BRADLEY, BSN, RN

Introductionecent advances in orthopaedic implant developmenthave increased the expected in vivo longevity of suchdevices and are the result of extensive research and

development activities, including the evaluation of ortho-paedic implants retrieved at the time of revision surgery1.Therefore, to help to ensure continued innovation, it is im-portant for the hospital to appropriately notify the devicemanufacturer of adverse events such as implant revisions. Infact, the United States Food and Drug Administration’s(FDA) Safe Medical Device Act (SMDA)2 requires the hospi-tal to notify the device manufacturer of adverse events, andan implant revision meets the definition of an adverse event.There is generally perceived to be a low level of providercompliance with adverse event reporting requirements3,which may negatively impact patient safety. For example,higher reporting rates could lead to implant recalls being is-sued earlier, saving patients from an unnecessary procedure.While physicians generally agree with the importance of ad-verse event reporting activities4, many are unaware of the re-porting tools available to them. This paper will demonstratehow adverse event reporting can affect patient safety and willidentify reporting tools that are readily available to mem-bers of the health-care industry.

FDA regulations require hospitals to report adverseevents that result in patient death to the FDA as well as to themedical device manufacturer2. Hospitals also are required to re-port to the medical device manufacturer any adverse events thatresult in serious injury. Serious injuries include those that arelife-threatening, those that require initial or prolonged hospital-ization, and those that require medical intervention to preventpermanent damage, disability, or congenital anomaly2.

Materials and Methodse reviewed adverse event reports by accessing the FDA’sMAUDE (Manufacturer and User Facility Device Expe-

rience) Database. The number of reported revisions of theSulzer Inter-Op acetabular implant was compared with thenumber of revisions of this implant as well as the number ofcomponents affected by the recall reported in the popularpress5 during the same time-period.

Results he earliest domestic report of an adverse event involvingthe Inter-Op implant was filed in 1999, at least a year be-

fore Sulzer issued its voluntary recall in December 2000. Thenumber of reports filed with the FDA through March 2001was 104 (Table I). At least forty-five of these reports were filedwith the FDA before the recall. However, through April 2001,Sulzer disclosed that at least 1700 revision procedures hadbeen performed, more than a sixteenfold increase over thenumber of revisions reported as adverse events.

The number of components affected by the recall (andtherefore at risk for revision) was disclosed to be 17,500. How-ever, many of those devices may have been implanted withbone cement and therefore would not have been subject to theloosening phenomena associated with the press-fit construct.

Discussionhe reporting results for the Inter-Op implant clearly dem-onstrate a trend toward underreporting of revision as an

adverse event.Errors such as the misspelling of the manufacturer’s

name (“Silzer”) by the individual who filed the report for thehospital often make it difficult to search for products, firmnames, and other important information in the adverse eventdatabase (Fig. 1).

R

W

T

T

TABLE I Data on Inter-Op Acetabular Revisions*

Number of domestic Inter-Op revisions through April 2001

1700+

Number of domestic Inter-Op medical device reports filed with the FDA through March 2001

104

Affected products implanted 17,500

*The number of domestic revisions of the Inter-Op acetabularimplant substantially exceeded the number that was reported tothe FDA.

TH E JO U R NA L OF BONE & JOINT SURGER Y · JBJS .ORG

VO LU M E 86-A · SUPPLEMENT 2 · 2004IN C REA S I N G PA T I E N T SA FE T Y AND OR TH OPA E D IC DE V ICE QUALIT Y V IA ADVERS E EVENT REP OR T ING ME CH A N I S M S

Adverse event reporting is a simple process. Informationand forms are readily available at www.fda.gov/cdrh. One mayalso complete and submit the forms online. In addition, third-party entities (in partnership with the FDA and at no cost tothe hospital) exist to enhance the quality of hospitals’ adverseevent reporting. One such example is the Medical ProductSurveillance Network (MedSun) (https://www.medsun.net),which is a pilot program that was begun in 2002 as a means offacilitating the electronic sharing of adverse event informationbetween hospitals and the FDA. Currently, approximately 180hospitals participate in this no-cost program, and additionalhospitals are being sought to participate.

Conclusionhe results of the present review suggest that revisions ofthe Sulzer Inter-Op acetabular implant were underre-

ported as adverse events. Had hospitals been more compliantwith the reporting requirements, Sulzer may have recognizedthis problem and issued a recall earlier, thereby keeping somepatients from undergoing the procedure with this implant and

thus saving them from an unnecessary revision. Patient safetymay be optimized by educating hospital stakeholders in therecognition of adverse events and the value of communicat-ing these events appropriately to the FDA, the device manu-facturer, or the local institutional review board. It is alsoimportant to recognize events that may not be defined as re-portable adverse events in order to prevent dilution of valu-able information. �

Corresponding author: Michael Tanner, MSBarnum Center, PO Box 3005, Birmingham, MI 48012-3005. E-mail address: mgtanner@beaumonthospitals.com

The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive pay-ments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

References

1. Hirakawa K, Jacobs JJ, Urban R, Saito T. Mechanisms of failure of total hip replacements: lessons learned from retrieval studies. Clin Orthop. 2004;420:10-7.

2. Department of Health and Human Services, Food and Drug Administration. Medical devices: medical device user facility and manufacturer reporting, certification and registration. Fed Regist. 1995;60:63577-606.

3. Castro FP Jr, Chimento G, Munn BG, Levy RS, Timon S, Barrack RL. An anal-

ysis of Food and Drug Administration medical device reports relating to total joint components. J Arthroplasty. 1997;12:765-71.

4. Engh GA, Wolf R. Responsibilities when confronting a defective surgical implant. Clin Orthop. 2003;407:54-8.

5. Sulzer warns about insurance for implants. Austin Business Journal 2001 May 21. www.bizjournals.com/austin/stories/2001/05/21/daily18.html.

T

Fig. 1

A screenshot of an adverse event re-

port submitted to the FDA. In this re-

port, Sulzer is misspelled as “Silzer”.

Errors such as this one contribute

to the difficulty of performing trends

analyses.