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Affinis ® Fracture Affinis ® Fracture Inverse Surgical technique

Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

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Page 1: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

Affinis® Fracture Affinis® Fracture InverseSurgical technique

Page 2: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,
Page 3: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

3

Contents

1. Introduction 4

2. Indications 5

3. Pre-operative planning 6

4. Instruction for surgery 7

5. Surgical technique Affinis Fracture 10

6. Conversion of primary fracture 15

7. Implants Affinis Fracture 17

8. Instruments Affinis Fracture 18

9. Intraoperative choice 19

10. Surgical technique Affinis Fracture Inverse 20

11. Conversion of a inversed fracture 28 12. Implants Affinis Fracture Inverse 30

13. Instruments Affinis Fracture Inverse 32

Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

NotePlease make yourself familiar with the handling of the instruments, the product-related surgical technique and the warnings, the safety notes as well as the recommendations of the instruction leaflet before using an implant manufactured by Mathys Ltd Bettlach. Make use of the Mathys user training and proceed ac-cording to the recommended surgical technique.

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4 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

1. Introduction

1.1 Introduction The field of shoulder prostheses has undergone rapid development in the last few years. Based on many years of very positive expe-rience with the Articula prosthesis, the next generations, Affinis Fracture and Affinis Fracture Inverse, has been developed.

The aim of fracture prosthesis is to restore mobility and to eliminate pain, so that the patient can manage the activities of everyday life.

A main objective here is the anatomical reconstruction of the rota-tor cuff, which is achieved through the precise and secure fixation of the tuberosities to the shaft of the humerus and the prosthesis.

You can continue to rely on the existing benefits such as continu-ously variable adjustment of height and retroversion, as well as primary stability provided by the spikes. Based on CT-models the prosthesis has been anatomically redesigned. Additionally the lat-est findings in refixation techniques have been incorporated. On growth of the tuberosities is furthermore improved by the newly added bioactive CaP coating.

The result will please you too:

Affinis Fracture & Affinis Fracture Inverse

1.2 Features and proven advantages • Simple and precise instrumentation• Bioactive CaP coating of the central part• Proven spike structure improves adhesion and osteointegration• Primary cementing of the stem, without the use of trial prostheses• Optimised refixation concept• Continuously variable height adjustment• Continuously variable retroversion adjustment• Optimum ligamentous balance• Same stem for Affinis Fracture and Affinis Fracture Inverse

Affinis Fracture Inverse• Glenosphere in two sizes• 2-Peg Metaglene

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5Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

2.1 Indications • Multi-fragment and comminute fractures of the humeral head with a

threat of a vascularisation disorder of the fragments• Fractures of the proximal humerus that cannot be treated with osteosyn-

thesis • Secondary fragment dislocation following osteosynthesis in the proximal

humerus in order to retain the joint function • In certain tumour related modifications of the proximal humerus

2.2 Contraindications • Acute or chronic infection, whether local or systemic (or the existence of a

corresponding case history)• Simultaneous paresis of the rotator cuff • Any concomitant affection and addictions that could jeopardise the func-

tion of the implant • Bone tumours in the region where the implant is anchored • Neurogenic joint destruction (syringomyelia, Charcot) • Defective humeral stem bone substance • Hypersensitivity to the raw materials used, above all to metal (e.g. cobalt,

chromium, nickel, etc.). To avoid allergic reactions, ceramic components are offered

• Immaturity of the skeleton

2. Indications

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30°

Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Transparent templates of the implants are available in the usual scale of 1.10:1, for pre-operative determination of the dimensional ratios of the shaft, head, and glenoid, if applicable.

The following X-rays of the affected shoulder are recommended:• a.p. image centred on the joint cavity• axial image• CT image

3. Pre-operative planning

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7Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Fig. 1

Fig. 2

4. Instructions for surgery

4.1 PositioningThe ideal position of the patient is in a half-sitting position, in the «beach-chair position», with the shoulder that is to be oper-ated upon projecting over the operating table. Make sure that the medial border of the scapula is still supported by the table.• The arm is wrapped in a sterile manner and can be laid on an

arm rail – but must remain freely movable• The shoulder joint should remain accessible from all sides,

including function testing and X-ray checks with the image converter

• The trunk component of the table should be raised by about 35°• Angle the lower leg component• Position and secure the head in the head support

4.2 ApproachThe delto-pectoral skin incision should be made from the tip of the coracoid process, along the anterior edge of the deltoid muscle, to the insertion on the shaft of the humerus. If neces-sary, the skin incision can be extended to the lateral third of the clavicle (as indicated by the broken line).

Other approaches are possible at the surgeons’ discretion.

The lateral skin flap is mobilised and the fascia is incised over the cephalic vein. This vein is usually retracted laterally, together with the deltoid muscle.

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8 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Fig. 3

Fig. 4

Fig. 5

This is followed by the vertical incision of the clavipectoral fascia.

After mobilisation of the coraco-brachial tendon group in a me-dial direction, the musculo-cutaneous nerve is palpated postero-medial to the tendons. The nerve should be held to the side with the tendons.

For better exposure, the insertion of the pectoralis major muscle can be notched close to the humerus (approx. 2 cm). In this case, please mark the highest point of its insertion beforehand. This will allow you to use the insertion as a reference point later.

The long biceps tendon serves as a guide for identifying the lesser and greater tuberosity.

The incision over the tendon proceeds in a proximal direction as far as the coraco-acromial ligament, which can be partially notched in contracted situations. The rotator cuff is then split in line with the fracture up to the base of the coracoid process. If not possible, the interval between the subscapularis and the supraspinatus should be split.

The biceps tendon should be tenotomised and reinforced with non-absorbable threads for later tenodesis on the proximal shaft (sulcus area). The intra-articular stump is resected.

After that, the axillary nerve is palpated at the front and under-side of the subscapularis. If the fracture extends into the shaft, the nerve must be exposed and held away.

Identification can be difficult in the case of older fractures and adhesions.

The axillary nerve must be protected throughout the entire op-eration.

Page 9: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

9Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

The head fragment, the tuberosities and the attached parts of the rotator cuff are now prepared carefully. It is important here to protect the periosteum on the proximal shaft.

Depending on the shape of the fragments, the initial situations can vary widely. If a fracture has resulted in an isolated greater tuberosity fragment and a lesser tuberosity fragment, these are reinforced with holding sutures. The mostly flat but compact calotte fragment is often tipped in a dorsal or medial direction. It must be extracted carefully, and used for obtaining cancel-lous bone. The glenoid is now assessed, and can likewise be replaced if necessary. The implantation of a glenoid component is described in the surgical technique for the Affinis total shoul-der prosthesis.

There is often a connection between the calotte and the dorsal parts of the greater tuberosity, which is osteotomised close to the head fragment, leaving the tuberosity and rotator cuff frag-ments.

The «4-fragment fracture» diagnosed pre-operatively is not always found. Often, the tuberosities themselves are also frag-mented. In this case, the smaller partial fragments should also be securely reinforced.

Tension-proof reinforcement of the tuberosities is very helpful for further manipulation during the implantation of the Affinis Fracture.

Fixation of the tuberosities should be carried out at the bone/tendon transition, with non-absorbable sutures, using the Masen-Allen or modified Kirschmayr technique.

Fig. 6

Fig. 7

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10 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

5.1 Humerus preparation and Stem implantation The humerus shaft is exposed, sparing the periosteum. Coagu-lations and any bone splinters are carefully removed from the intramedullary canal. The medullary space is now drilled step by step using the Medullary Reamer, until the desired stem size is reached. The stem size always corresponds to the numbering of the Medullary Reamer:

Medullary Reamer Ø in mm Stem size

6 6

9 9

12 12

Four holes are subsequently drilled at the edge of the shaft of the humerus, and two sutures are placed in a U-shape. These should be inserted medially and laterally of the sulcus, before the prosthesis stem is cemented in.

Before cementing the Central Part is mounted in a central position (laser marking) onto the Stem. This means that after cementing, it is still possible to displace the Central Part of the prosthesis 5 mm caudally or cranially respectively, for the pur-poses of exact anatomical positioning.

The Adjusting Screw is used to fix the Central Part and Stem temporarily. The use of a medullary plug is recommended.

Fig. 8

Fig. 9

Fig. 10

5. Surgical technique Affinis Fracture

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56 mm 43 mm

13 mm

Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

5.2 Height positioningPrimary landmarks for correct height adjustment:• The Central Part is placed on the medial calcar, which usually

remains static and is very suitable as a starting point for height adjustment. Calcar remnants on the humeral head have to be included in the calculation for the correct length adjustment.

• If there is an extreme comminution of the medial metaphysis, the anatomical repositioning using the medial calcar can be-come impossible. A further possibility for setting the correct height is then provided by the measurement method after Murachovsky et al (JSES 2006, 15, 675-678): Here, the height from the upper edge of the pectoralis major muscle attachment on the shaft of the humerus to the upper edge of the pros-thesis head is measured. According to the anatomical study, this is 56 mm on average. For simplification, the distance from the pectoralis major to the shoulder of the central part can be measured, with the adjustment value here being 43 mm.

Bone cement is introduced into the medullary space, the ante-rior Fixation Screw or the Retrotorsion Pointer is aligned to the lower arm, and the pre-mounted prosthesis (Central Part and Stem) is inserted. The alignment towards the lower arm corre-sponds to a retroversion of 30° to the lower arm and 20° to the transepicondylar axis.

Bone cement must be removed, so as not to hinder adjustment of the central part. Any cavities remaining distally can be filled up with chips of cancellous bone.

After the bone cement has hardened, the Trial Head is mounted (the size depends on the calotte that has been removed). In order to avoid overstuffing, in cases of doubt the smaller head should be used.

The fine adjustment of height and retroversion is now carried out in accordance with the anatomical circumstances, with the aim of achieving an optimum ligament tension, as well as cen-tring of the prosthesis to the glenoid.

For this, in a neutral position, the Central Part Adjusting Screw is aligned to the lower arm. Alternatively, the Retrotorsion Pointer can also be used. With both methods, a retrotorsion of 30° to the lower arm or accordingly 20° to the transepicondylar axis is ensured.

The Adjusting Screw should be tightened as soon as the opti-mum setting has been achieved.

Fig. 11

Fig. 12

Fig. 13

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12 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Caution!The Central Part must completely cover the slits on the Stem (bracing mechanism).

To perform reduction The Adjusting Screw is loosened, and the Affinis Fracture is ad-justed so as to be anatomically correct in terms of length and rotation.

Opportunities for monitoring during surgery:• Checking is performed laterally through the placement of the

greater tuberosity. The upper edge of the greater tuberosity should come to rest 5–8 mm below the calotte height, and as far as possible it should lie edge to edge on the lateral shaft.

• The acromio-humeral distance should be approx. 10 mm (rule of thumb: forefinger width between tendon and acromion).

After the desired position has been achieved, the Adjusting Screw is tightened and the following parameters are checked by moving the arm whilst monitoring with an image converter:• The distance between the greater tuberosity and the head

(5–8 mm)• The degree of retroversion (centring to the glenoid)• The size of the head• The prosthesis height (subacromial space, ligamentous ten-

sion).

Fig. 14

Fig. 15

Fig. 16

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13Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

The Trial Head is now removed and the final fixation of the Central Part to the Stem is ensured with the following steps:

1st step:Pre-fixation of the Central Part with the Allen key, until a re-sistance is encountered.

2nd step:The Counter Wrench is mounted, to secure the Central Part against rotation, and the Torque Wrench is inserted.

The use of the Counter Wrench is mandatory.

The Counter Wrench and the Torque Wrench must be used by the same person, as this is the only way to be sure of avoiding Stem rotation in the cement socket.

Tensioning takes place by turning the Torque Wrench clock-wise. When the indicator of the Torque Wrench points next to the wrench handle, permanent bracing has been achieved.

The Adjusting Screw can now be removed.

The definitive prosthesis head (corresponding to the size of the Trial Head) is then fixed through firm mounting and slight turning.

Fig. 17

Fig. 18

Fig. 19

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14 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

The following steps lead to stable refixation:

Holding or fixation sutures1. Fixation of the greater tuberosity takes place in the bone/

tendon transition in the lateral drilled hole for reintegration of the tuberosity close to the Head (red suture). This ensures the anatomical transition of the supraspinatus to the pros-thesis head. Where possible, the lesser tuberosity should be included in this fixation.

2. The positioning and fixation of the two tuberosities is now carried out in anatomical position relative to one another and to the shaft (green suture).

Fixation or compression sutures3. Using the sutures placed in the shaft at the outset, the tu-

berosities are now fixed on the shaft of the humerus. These sutures must be tightened forcefully.

4. The whole package is then compressed onto the bioactively coated Central Part, by means of encircling suture or cable. A high degree of primary stability is thereby achieved. The course of the suture runs through the medial drilled hole, through the tendon/bone interval, and is fixed over the two tuberosities.

For the fixation of the tuberosities, cable (encompassing circular suture) and/or non-absorbable sutures should be used.

Additional fragments and cancellous bone are introduced into any remaining cavities and gaps, and are included in the fixation where possible. Secure and anatomically correct fixation of the tuberosity fragments is of greatest importance for the func-tional outcome of the operation.

Finally, tenodesis of the biceps tendon is carried out in the sulcus area. A functional check, where possible using an image con-verter with image documentation, and wound closure via Redon drainage, is recommended.

Fig. 20

Fig. 21

Fig. 22

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15Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

6. Conversion of primary fracture

Fig. 23

Fig. 24

To make revision from primary fracture arthoplasty easier and less invasive, we have developed a unique and dedicated Fracture Inverse implant. Failed primary fracture implants can now be changed to an inverse arthroplasty whilst leaving the Stem in place.

6.1 Removal of the prosthesis implant head To remove the prosthesis Head, perform light blows to the edges of the prosthesis Head.

6.2 Removal of Fracture Central PartThe Counter Wrench is mounted, to secure the implant against rotation, and the Torque Wrench is inserted.

The use of the Counter Wrench is mandatory.

The Counter Wrench and the Torque Wrench must be used by the same person, as this is the only way to be sure of avoiding Stem rotation in the cement socket. Disconnection takes place by turning the Torque Wrench counter-clockwise. Remove the Central Part and check the stability of the Stem. If the Stem is still fixed well in the cement mantle, the Stem may be left in place. Before continuing with the Central Part, the implantation of the Metaglene has to be performed (see chapter 10). When the Metaglene is implanted, the appropriate Trial Gleno-sphere can be mounted and secured. Afterwards the Inverse trial implants must be mounted. The height (10 mm) and retro-version of the Central Part can now be adjusted as in the Affinis Fracture. By using the different sizes of the central com-ponents, the height can additionally be chosen (either 0 or +3 mm). Please check correct implant size with the trials.

The Adjustment Screw can help to primary fix the Central Part on the stem.

To minimise the risk of infection we recommend to exchange the spreading screw with the: Affinis Fracture Revision Screw 62.34.0078

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16 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Fig. 25

Revision instruments

Item no. Description

61.34.0050 Affinis Slide Hammer

61.34.0051 Articula Stem Adapter

61.34.0053 Affinis Fracture Stem Adapter

6.3 Explantation of Fracture StemIn some revision cases the Stem may no longer be sufficiently fixed in the shaft. The Stem must then be removed and re-placed by a new implant.

In those cases our extraction instrumentation can be used:Unscrew the Fixation Screw in the prosthesis stem. Screw the Revision Adapter into the Stem and reject the prosthesis stem with the Sledge Hammer.

Revision instruments are not included in the standard case.

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17Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

7. Implants Affinis Fracture

Affinis Fracture Head

Item no. Description

60.25.0042 Affinis Fracture Head 42

60.25.0045 Affinis Fracture Head 45

60.25.0048 Affinis Fracture Head 48

Affinis Fracture Central Part

Item no. Description

60.21.0000 Affinis Fracture Central Part 1

60.21.0001 Affinis Fracture Central Part 2

Affinis Fracture Stem

Item no. Description

60.21.0006 Affinis Fracture Stem 6/125

60.21.0009 Affinis Fracture Stem 9/125

60.21.0012 Affinis Fracture Stem 12/125

60.21.0209 Affinis Fracture Stem 9/200

60.21.0212 Affinis Fracture Stem 12/200

62.34.0078 Affinis Fracture Revision Screw

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18 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

8. Instruments Affinis Fracture

Affinis Fracture Instrument Set item no. 60.01.0100

Item no. Description

5241.00.3 Handle

6008.00.04 Adjusting Screw

502.06.10.06.0 Affinis Medullary Reamer 6

502.06.10.09.0 Affinis Medullary Reamer 9

502.06.10.12.0 Affinis Medullary Reamer 12

6020.00 Torque Wrench

61.34.0048 Affinis Counter Wrench Inverse/Fracture

60.02.1010 Affinis Fracture Retrotorsion Pointer left

60.02.1011 Affinis Fracture Retrotorsion Pointer right

504.99.04.00.0 Affinis Hexagonal Screwdriver

60.02.1042 Affinis Fracture Trial Head 42

60.02.1045 Affinis Fracture Trial Head 45

60.02.1048 Affinis Fracture Trial Head 48

60.03.0100 Affinis Fracture Tray

60.03.0102 Affinis Fracture Lid

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19Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

9. Intraoperative choice

3–4 part Fracture

No RC defectIndication

Revision

With RC defect

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Fig. 26

Fig. 27

10. Surgical technique Affinis Fracture Inverse

10.1 Glenoid preparation and Metaglene implantationMount the Holding/Rotation Rod onto the Metaglene Drill Guide.Use the Metaglene Drill Guide to position the central Kirschner Wire.The inferior border of the guide must be flush with the inferior border of the glenoid. This will lead to an implant overhang of at least 4.5 mm to reduce primary notching.

Use Glenoid Reamer 28 over the Kirschner Wire to ream the glenoid.

Stay in the subchondral bone. Never ream into the cancellous bone.

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21Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Fig. 28

Fig. 29

Fig. 30

The Glenoid Reamer 42 is required to avoid conflicts between the Glenosphere and any distant bone of the glenoid. Make sure that the rim of the glenoid does not have any bony promi-nences that could interfere with the Glenosphere.

To prepare the peg holes, slide the Metaglene Drill Guide over the Kirschner Wire and correctly align the guide.

Use the Peg Drill Metaglene to drill the superior anchoring hole first.

The drill has an automatic stop.

Remove the drill and position the Fixation Peg to prevent rota-tion of the guide.

Use the Peg Drill Metaglene to drill the inferior anchoring hole.

Important !When using the Revision Metaglene with one peg, take care to use the drill bit marked with “revision” to drill the superior hole.

Remove the instruments.

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22 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Fig. 31

Fig. 32

Slide the Metaglene on the Metaglene Impactor.

Set the Metaglene and gently impact it with the Metaglene Impactor.Make sure to be working in the same direction as the drilled peg holes. Do not incline the instrument.

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23Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Hold the Lag Screw Drill Guide against the correspondent metaglene hole (anterior and posterior). The Lag Screws can be directed in an angular freedom of 10° (+/- 5°). Insert the 3.2 mm drill bit and drill the holes for the Lag Screws parallel or slightly convergent to the pegs. Fix these two screws (4.5 mm) first in alternating mode. This will ensure that the Metaglene becomes flush on the reamed glenoid.

The superior screw can be drilled with an angular freedom of 30° (+/- 15°). Using the Locking Screw Drill Guide in direction of the base of the coracoid process, drill with the 2.5 mm Drill Bit.

Important!Make sure to position the Drill Guide flush and central on the bone.

Exceeding this angular freedom (+/- 15°) impairs the screw fixation.

Block the Metaglene with the superior Locking Screw (4.0 mm)to secure the fixation.

Fig. 33

Fig. 34

Fig. 35

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24 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

If wished the Trial Glenosphere can be mounted and secured to perform trial reduction.

Fig. 37

10.2 Implantation of Affinis Fracture Stem The humerus shaft is exposed, sparing the periosteum. Coagu-lations and any bone splinters are carefully removed from the intramedullary canal. The medullary space is now drilled step by step using the Medullary Reamer, until the desired stem size is reached. The stem size always corresponds to the numbering of the Medullary Reamer:

Medullary Reamer Ø in mm Stem size

6 6

9 9

12 12

Four holes are subsequently drilled at the edge of the shaft of the humerus, and two sutures are placed in a U-shape. These should be inserted medially and laterally of the sulcus, before the prosthesis stem is cemented in.

Fig. 36

Fig. 38

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Before cementing, the Fracture Inverse Trial is mounted in a central position onto the Stem that is to be implanted. This means that after cementing, it is still possible to displace the Central Part of the prosthesis 5 mm caudally or cranially re-spectively, for the purposes of exact anatomical positioning.The Retrotorsion Guide does make retroversion of 0° if aligned with the forearm.

The use of a medullary plug is recommended.Perform reduction and verify the function.

Attention!The Central Part must completely cover the slits on the Stem (bracing mechanism).

Bone cement must be removed, so as not to hinder adjustment of the Central Part. Any cavities remaining distally can be filled up with chips of cancellous bone.

10.3 Implantation of Glenosphere and final insertAfter having chosen the Glenosphere and inlay sizes screw the Metaglene Assembly Rod onto the Metaglene.

Secure it with the Assembly Rod Holder …

... or with the handle of the Glenosphere Pusher.

Fig. 39

Fig. 40

Fig. 41

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26 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Slide the Glenosphere carefully over the Metaglene Assembly Rod. Slide, and then screw the Glenosphere Pusher on the rod. This will push the Glenosphere onto the Metaglene. Stop as soon as you have to push with increased force. Turn back the Glenosphere Pusher and check if the Glenosphere is fully seated on the Metaglene. The Glenosphere will come off easily, if not fully seated.

Optionally, it is possible to first place the Glenosphere onto the Metaglene. Next, screw in the Metaglene Assembly Rod and press the Glenosphere onto the Metaglene using the Gleno-sphere Pusher.

The full connection between Glenosphere and Metaglene can additionally be checked through the following parameters:

1. The superior cut out of the Glenosphere needs to be flush with the metal back.

2. The inferior border of the Glenosphere must be flush with the backside of the Metaglene.

Finally, screw in the Fixation Screw to secure the snap-in of Gle-nosphere. If the screw can not be fixed down, the Glenosphere may not be fully fixed on the Metaglene and the seating has to be checked again.

Fig. 42

Fig. 43

Fig. 44

Fig. 45

Page 27: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

27Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

The Affinis Fracture Inverse or Articula Inverse Central Part is mounted on the shaft and the appropriate height and retrover-sion is adjusted.The Adjusting Screw is used to fix the Central Part and Stem temporarily.When the correct positioning has been reached, the Counter Wrench is introduced into the medial hole to secure the Central Part against rotation, and the Torque Wrench is inserted.

The use of the Counter Wrench is mandatory.

The Counter Wrench and the Torque Wrench must be used by the same person, as this is the only way to be sure of avoiding stem rotation in the cement socket.After having secured the Central Part, it is recommended to reattach remaining tuberosities and/or rotator cuff tendons to improve rotation and stability of the shoulder joint.

The following steps lead to a stable refixation:

Positioning sutures1. The positioning and fixation of the two tuberosities is carried out in anatomical position relative to one another (green suture).

Fixation or compression sutures2. Using the sutures placed in the shaft at the outset, the tuber-osities are now fixed on the shaft of the humerus. These sutures must be tightened forcefully.

3. The whole package is then compressed onto the bioactively coated Central Part, by means of encircling suture or cable.

A high degree of primary stability is thereby achieved. The course of the suture runs through the medial drilled hole, through the tendon/bone interval, and is fixed over the two tuberosities.For the fixation of the tuberosities, cable (encompassing circular suture) and/or non-absorbable sutures should be used.Additional fragments and cancellous bone are introduced into any remaining cavities and gaps, and are included in the fixa-tion where possible. Secure and anatomically correct fixation of the tuberosity fragments is of greatest importance for the func-tional outcome of the operation.

Finally, tenodesis of the biceps tendon is carried out in the sul-cus area. A functional check, where possible using an image converter with image documentation, and wound closure via Redon drainage, is recommended.

Fig. 46

Fig. 47

Page 28: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

28 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

11. Conversion of a inversed fracture

Fig. 48

11.1 Removal of Fracture Inverse Central PartThe Counter Wrench is mounted, to secure the Central Part against rotation, and the Torque Wrench is inserted.

The use of the Counter Wrench is mandatory.

The Counter Wrench and the Torque Wrench must be used by the same person, as this is the only way to be sure of avoiding stem rotation in the cement socket. Disconnection takes place by turning the Torque Wrench counter-clockwise. Remove the Central Part and check the stability of the Stem. If the Stem is still fixed well in the cement mantle, the Stem may be left in place.

11.2 Glenosphere removalRemove the Fixation Screw of the Glenosphere.

Screw the Glenosphere Extractor into the Glenosphere. The re-vision device removes the Glenosphere from the Metaglene.

Providing the stability of the Metaglene is secure a new Gleno-sphere can be implanted. Otherwise the Metaglene has to be revised too.

Affinis Inverse Metaglene Extractor 61.34.0055

Fig. 50

Fig. 49

Page 29: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

29Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Mount new Central Part and adjust height (10 mm) and retro-version.

To minimise the risk of infection we recommend to exchange the spreading screw with the: Affinis Fracture Revision Screw 62.34.0078

The Adjustment Screw can help to primary fix the Central Part on the Stem.

The definitive prosthesis Head (corresponding to the size of the Trial Head) is then fixed through firm mounting and slight turning.

11.3 Explantation of Fracture StemIn some revision cases the Stem may no longer be sufficiently fixed in the shaft. The Stem must then be removed and replaced by a new implant.

In those cases our extraction instrumentation can be used:Unscrew the Fixation Screw in the prosthesis stem. Screw the Revision Adapter into the Stem and reject the prosthesis stem with the Sledge Hammer.

Revision instruments are not included in the standard case.

Fig. 51

Fig. 52

Revision instruments

Item no. Description

61.34.0050 Affinis Slide Hammer

61.34.0051 Articula Stem Adapter

61.34.0053 Affinis Fracture Stem Adapter

61.34.0055 Affinis Inverse Metaglene Extractor

Page 30: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

30 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

12. Implants Affinis Fracture Inverse

Affinis Inverse Metaglene

Item no.

60.30.3150

Affinis Inverse Revision Metaglene

Item no.

60.30.3151

Affinis Inverse Glenosphere

Item no. Description

60.30.3039 Affinis Inverse Glenosphere 39

60.30.3042 Affinis Inverse Glenosphere 42

Affinis Inverse Lag Screw

Item no. Description

60.30.4418 Affinis Inverse Lag Screw 4.5x18

60.30.4422 Affinis Inverse Lag Screw 4.5x22

60.30.4426 Affinis Inverse Lag Screw 4.5x26

60.30.4430 Affinis Inverse Lag Screw 4.5x30

60.30.4434 Affinis Inverse Lag Screw 4.5x34

60.30.4438 Affinis Inverse Lag Screw 4.5x38

Affinis Inverse Locking Screw

Item no. Description

60.30.5424 Affinis Inverse Locking Screw 4.0x24

60.30.5430 Affinis Inverse Locking Screw 4.0x30

60.30.5436 Affinis Inverse Locking Screw 4.0x36

60.30.5442 Affinis Inverse Locking Screw 4.0x42

60.30.5448 Affinis Inverse Locking Screw 4.0x48

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31Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Articula Inverse

Item no. Description

60.30.9390 Articula Inverse 39+0

60.30.9393 Articula Inverse 39+3

60.30.9420 Articula Inverse 42+0

60.30.9423 Articula Inverse 42+3

Affinis Fracture Stem

Item no. Description

60.21.0006 Affinis Fracture Stem 6/125

60.21.0009 Affinis Fracture Stem 9/125

60.21.0012 Affinis Fracture Stem 12/125

60.21.0209 Affinis Fracture Stem 9/200

60.21.0212 Affinis Fracture Stem 12/200

62.34.0078 Affinis Fracture Revision Screw

Affinis Fracture Inverse

Item no. Description

60.30.6390 Affinis Fracture Inverse 39+0

60.30.6393 Affinis Fracture Inverse 39+3

60.30.6420 Affinis Fracture Inverse 42+0

60.30.6423 Affinis Fracture Inverse 42+3

Page 32: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

32 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

13. Instruments Affinis Fracture Inverse

Needed instruments of the Affinis Inverse Set:

Item no. Description

292.250 Kirschner Wire 2.5/150

5223.00 Impactor

60.02.2034 Affinis Inverse Holding/Rotation Rod

60.02.2032 Affinis Inverse Screwdriver 3.5

61.34.0001 Affinis Inverse Metaglene Drill Guide

61.34.0002 Affinis Inverse Glenoid Reamer 28

61.34.0003 Affinis Inverse Glenoid Reamer 42

61.34.0005 Affinis Inverse Metaglene Assembly Rod

61.34.0006 Affinis Inverse Glenosphere Pusher

61.34.0007 Affinis Inverse Peg Drill Metaglene

61.34.0009 Affinis Inverse Metaglene Impactor

61.34.0012 Affinis Inverse Trial Glenosphere 39

61.34.0013 Affinis Inverse Trial Glenosphere 42

61.34.0014 Affinis Drill Guide Locking Screw

61.34.0015 Affinis Metaglene Revision Drill

61.34.0018 Affinis Inverse Fixation Peg

61.34.0019 Affinis Inverse Depth Gauge

61.34.0020 Affinis Inverse Drill-Guide Lag Screws

61.34.0021 Affinis Inverse Core-Hole Drill Bit 3.2

61.34.0022 Affinis Inverse Core-Hole Drill Bit 2.5

61.34.0023 Affinis Inverse Screwdriver 2.5

61.34.0024 Affinis Inverse Glenosphere Extractor

61.34.0025 Affinis Fracture Inverse Trial Inlay 39+0

61.34.0026 Affinis Fracture Inverse Trial Inlay 39+3

61.34.0027 Affinis Fracture Inverse Trial Inlay 42+0

61.34.0028 Affinis Fracture Inverse Trial Inlay 42+3

61.34.0029 Affinis Fracture Inverse Trial Body

61.34.0030 Articula Inverse Trial Body

61.34.0033 Affinis Inverse Assembly Rod Holder

61.34.0048 Affinis Counter-Wrench Inverse/Fracture

Affinis Inverse 60.01.3000Affinis Fracture 60.01.0100

Page 33: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

33Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Notes

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34 Mathys Ltd Bettlach • Güterstrasse 5 • P.O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com

Notes

Page 35: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,
Page 36: Affinis Fracture Affinis Fracture Inverse · Fracture and Affinis Fracture Inverse, has been developed. The aim of fracture prosthesis is to restore mobility and to eliminate pain,

Local Marketing Partners in over 25 countries worldwide...

Australia Mathys Orthopaedics Pty Ltd Lane Cove West, NSW 2066 Tel: +61 2 9417 9200 [email protected]

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Belgium Mathys Orthopaedics Belux N.V.-S.A. 3001 Leuven Tel: +32 16 38 81 20 [email protected]

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P. R. China Mathys Ltd Bettlach Shanghai Representative Office Shanghai, 200041 Tel: +86 21 6217 2526 [email protected]

Switzerland Mathys Ltd Bettlach 2544 Bettlach Tel: +41 32 644 1 644 [email protected]

United Kingdom Mathys Orthopaedics Ltd Alton, Hampshire GU34 2QL Tel: +44 8450 580 938 [email protected]

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