PROCOTYL L. Acetabular Cup System

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PROCOTYL® L

Acetabular Cup System

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PROCOTYL

®

_{L Acetabular Cup System}

Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects.

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PROCOTYL® L Acetabular Cup System

Design

Rationale

The PROCOTYL® L Acetabular Cup System provides unsurpassed surgical flexibility for shell fixation and bearing material choices. The shells are manufactured from titanium alloy, the material of choice for bio-compatibility. An irregularly layered porous titanium bead coating enhances initial fixation and long term bone

apposition. An average porosity of 30% allows for enhanced bone on-growth. Cups are available with or without additional hydroxyapatite coating. Three screw holes located in one quadrant of the cup allow for surgical flexibility.

Intra-operative flexibility: PROCOTYL® L Acetabular Cup System system accepts ceramic, metal and and A-CLASS® advanced cross-linked poly liners. Liners are securely locked by the RIM-LOCK fixation system and the 18° internal taper.

PROCOTYL® L acetabular components are recommended to be used in conjunction with PROFEMUR® femoral components and their unique modular neck system. Modular necks allow for optimal restoration of patient’s original hip biomechanics. Independent of the femoral shaft position, it allows control over leg length, offset, alignment and version.

Today’s orthopedic surgeons face many challenges with acetabular fixation. As improved mechanical designs, bearing materials and techniques diminish short term failures, the focus has moved to long term survivorship.

The PROCOTYL® L Acetabular Cup System has integrated several design features to address contemporary issues. The intrinsic design features that address contemporary two-piece acetabular cup issues, coupled with multiple liner configurations, make the PROCOTYL® L Acetabular Cup System the choice for surgeons requiring a wide range of primary, revision and bearing material options. The unique internal taper and RIM-LOCKlocking groove allows polyethylene, metal, or ceramic bearing liners to be used in a single shell design. A 14° rim flare geometry transfers load to the periphery of the acetabulum, providing long term intrinsic stability. Cups come with three holes for additional fixation by means of screws. From size 44 and up these holes are provided with a plug, including the apical hole.

The 3 in-line screw holes are positioned away from the dome of the cup to achieve a maximum lever arm, optimal purchase in the illiac wing and thereby maximizing stability. The screws have a 200 freedom of direction.

X-ray courtesy of Dr. E. Tozzi, Pisa-Calambrone, Italy

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3 PROCOTYL® L Acetabular Cup System

Design Features of the

PROCOTYL® L Cup

Ordering Information

Templates LNG2CL01E 00 Lip Liner LNG2CL02E 150 Lip Liner Surgical

Technique EH002-807E Instruments APH04400

Implants PLPCKITA non coated cups PLHAKITA HA-coated cups CERAKITB ceramic liners XLINKITB poly liners METAKITB metal liners SUFIKITA metal heads CERAKITA ceramic heads

Secure initial stability Additional screw fixation

Increase ball bearing diameters 46mm cup - 32mm head 52mm cup - 36mm head Comes in sizes 42 - 68 (2 mm increments) Ceramic liner • Alumina Matrix composite • 00 lip • Standard offset • Taper locking • 28, 32 and 36mm inside diameters Metal liner • Cobalt Chrome • 00 lip • Standard offset • Taper locking • 28, 32 and 36mm inside diameters Proven on-growth surface

Sintered Titanium beads 30% Porosity - avg. 114 µm pore size

Proven outer geometry • Hemi-spherical - Single radius 152°

• Flattened dome • Equatorial rim flare (140)

A-Class® Advanced X-linked Poly liner • 00 and 150 lip options • 3600 lip position • 28, 32 and 36mm inside diameters

PROCOTYL® L cup

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Chapter 2 Pre-operative Planning

2

Pre-operative

Planning

Pre-operative Planning

Pre-operative assessment of the appropriate size and position of the acetabular component will provide intra-operative guidance for acetabular reaming. A bilateral A/P x-ray of the pelvis will aid in leg length and offset assessment and management. Leg length discrepancies should be determined pre-operatively and addressed intra-operatively.

Radiographic overlays for the PROCOTYL® L Acetabular Cup System are available in 15% magnification, with 0° or 15° liners. To determine the acetabular cup size and position, place the overlay outline at approximately 45° of abduction and the center of rotation within the anatomic center of the acetabular image.

Note: The use of a magnification marker will aid in determining the x-ray magnification.

Caution: Pre-operative templating is intended for estimation purposes only. Final component size and position should be determined intra-operatively.

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5 Chapter 3 Surgical Technique

3

Surgical

Technique

Preparation of the Acetabulum

Osteophytes should be removed to enable assessment of the true acetabular rim. Reaming should be sequential and start with the smallest reamer that conforms to the acetabular cavity. Reaming to the edge of the reamer will mimic a full

hemisphere. Gradually enlarge the acetabulum by reaming articular cartilage until a continuous surface of cancellous bone is exposed.

Note: PROCOTYL® L shells come in 2mm increments, ranging from 42 - 68 mm.

Ream to the size of the component to be implanted. This will provide a 2mm press fit at the rim, and a 1mm press fit at the dome.

Reaming depth, acetabular shape and size can be confirmed by using a trial shell sizer.

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PROCOTYL® L Cup Reaming Guide

For equatorial press-fit of 1mm

ream to 2mm ream to PROCOTYL® L size 42 43mm 42mm PROCOTYL® L size 44 45mm 44mm PROCOTYL® L size 46 47mm 46mm PROCOTYL® L size 48 49mm 48mm PROCOTYL® L size 50 51mm 50mm PROCOTYL® L size 52 53mm 52mm PROCOTYL® L size 54 55mm 54mm PROCOTYL® L size 56 57mm 56mm PROCOTYL® L size 58 59mm 58mm PROCOTYL® L size 60 61mm 60mm PROCOTYL® L size 62 63mm 62mm PROCOTYL® L size 64 65mm 64mm PROCOTYL® L size 66 67mm 66mm PROCOTYL® L size 68 69mm 68mm

A trial shell adapter (APA09310) is put onto the tip of the cup inserter instrument before mounting the trial shell which corresponds with the final reamer. The adapter is kept in place by a locking ring; the shell is fixed by turning the central rod of the cup inserter clock-wise. Following trialing the shell and adapter are to be removed from the cup inserter instrument.

Use of the PROCOTYL® L trial acetabular components is strongly suggested in order to verify depth of reaming as the initial stability of the acetabular component is predominatly provided by its rim flare. Reaming therefore needs to be performed sufficiently deep in order to fully seat the cup within the bony cavity.

Note: The trial shells are equal in dimensions to the corresponding final implant but without rim flare and porous coating.

Note: In cases where hard (sclerotic) bone is encountered and/or most of the subchondral plate is kept intact, the user may experience some difficulty inserting the trial shell. This may indicate a very tight fit with the shell and it is recommended that the cavity is reamed up by 1mm. In cases where there is no hard bone and the trial cup can easily be inserted but nevertheless initial final implant stability can not be obtained, it may be of help to ream the acetabular cavity slightly deeper with the last used reamer.

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Inserting the Shell

A full series of cup size dedicated adapters (APA09303 - APA09309) is available in the instrument kit. The adapter corresponding to the preferred cup size is put onto the tip of the cup impactor, followed by the acetabular component. The pins on both arms of the adapter are to match the dimples in the face of the cup. This method of stabilization provides full control over the position of the cup at impaction.

Note: The face of the shell has three laser marked lines that correspond to the screw hole locations. Position the marks between the plane of the anterior-superior and the anterior-inferior iliac spine.

Seat the shell with a series of firm mallet blows on the end of the impactor.

Once seated, the cup inserter instrument can be removed by turning the central rod counter-clockwise. Complete seating of the implant can be confirmed through the apical hole.

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Inserting the Shell

(continued)

Screw placement can begin once the shell component is securely positioned and the impactor is removed.

In case re-positioning of the cup is required, the cup inserter instrument can be mounted again and the cup can be removed, re-oriented and re-implanted. If a deeper seating is preferred, it might help to attach the cup impactor tip to the universal rod and use this as a cup inserter device. The flat of the cup impactor tip is to be positioned properly against the flat of the cup dome before hitting the universal handle with a hammer.

Two alignment rods (APA09302) can be mounted on the inserter to aid in positioning the implant at 45° of abduction and 15° of ante-version. Position the longitudinal guide rod 90° to the midline of the patient to position the shell at 45°. Position the transverse guide rod parallel to the midline of the patient as this will place the implant at 15° of inclination. Positions given are based on a posterior approach / affected side up.

Note: The patient might have shifted during surgery and the alignment rods can therefore only be seen as an orientation guide.

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Screw Placement and Fixation

PROCOTYL® L shells are designed to allow additional fixation by means of screws; the shells come pre-plugged except for size 42 mm shell. Determine screw location and select a suitable length drill bit. Drill bits are provided in 3.2 and 4.5mm diameters; the drill guide is also available in 3.2 and 4.5mm diameters. Insert the drill into the guide and carefully drill through the acetabular cortex.

Use the screw depth gauge to determine the appropriate screw length.

Caution: Due to intra-pelvic vascular structures, screw placement in the medial aspect of the acetabulum must be carefully considered.

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Chapter 3 Surgical Technique

Grasp the screw head with the screw holding forceps and utilize the hex screwdiver to orient and fixate the screw. Centralize the screw to protect the threads from abrasion and assures countersinking of the screw head within the hole. Release the screw holding forceps to allow for countersinking of the screw head, which allows full seating of the prosthetic liner. Full seating of the liner can be confirmed with the use of a trial liner prior to impacting the prosthetic liner, or by manually examining the inner surface of the shell to check if the screw head is proud.

Caution: To ensure proper prosthetic liner seating in the shell, all screw heads must be seated below the inner surface of the shell. Full and unobstructed seating is crucial to implant fit and longevity.

Trial Liner Placement

Trial liners that match the prosthetic implant are available to evaluate the optimum position of the implant and the preferred liner. With the prosthetic shell secured within the reamed cavity, insert the trial liner into the shell.

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Note:Care should be taken to avoid neck / liner impingement in all potential positions. The acetabular component should be repositioned as necessary to relieve impingement. Alternatively, a change of modular neck could possibly solve the impingement phenomenon. Position the trial liner in the desired orientation and secure it with the captured screw using a 3.5mm hex screwdriver. If a lipped liner is to be used, a reference mark should be made on the acetabulum to aid in proper positioning of the final liner implant.

Note: The hard-on-hard liners allow for larger bearing diameters than polyethylene liners, which causes an ‘overlap’ in the femoral head size range. The difference between group C 28/32 and group E 32/36 is made clear by trial liner colour coding.

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Dome Plug Insertion

After a satisfactory trial reduction and assessment of joint stability, seal the dome hole with the special plug.

Whereas the screw hole plugs are pre-mounted, the dome hole plug comes separate in the packaging (except size 42 mm). The plug can be attached to the tip of the straight hex driver shaft and will be kept in place by the retaining mechanism.

Note: The dome hole plug should not be inserted until a trial reduction with the trial liner is completed.

Liner Placement

Assemble a 0° or 15° lipped liner positioner to the impactor handle. Place the liner and hold it by hand.

Place the liner in the selected position making sure the face of the liner is parallel to the face of the shell. Apply a series of firm mallet blows to fully seat the liner, followed by removal of the inserter.

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Caution: Improper position and impaction of the liner will damage the liner.

Hard-on-hard bearing liners are inserted by hand. The inserter handle with mounted liner positioner is applied and fixation is achieved by some light taps.

Note: Make sure that the rim of the liner is circumferentially flush with the face of the shell before final seating.

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X-linked Poly Liner Removal

To remove a poly liner, a flexible drill bit with an acetabular drill guide is used to drill a hole slightly off center from the liner apex. Using a 3.5mm hex screwdriver, a cancellous screw (20mm) is then advanced into the drilled hole until the liner is removed.

Ceramic / Metal Liner Removal

To remove a ceramic or metal liner a liner extractor is used. Position the tip of the liner extractor in a dimple in the face of the cup and apply some short mallet strokes. This results in a counteraction loosening the liner; repetitive action might be necessary.

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Technique

Overview

Chapter 3 Surgical Technique 1. Preparation of the Acetabulum - reaming 4. Screw Placement - drilling 7.Trial Liner Insertion 1. Preparation of the Acetabulum - trial shell to check reamed cavity 3. Inserting the Shell 5. Screw Placement - fixation 8. Dome Plug Insertion 6. Trial Liner Evaluation 9. Liner Placement Liner Options: • XLPE 00 and 150 • Ceramic • Metal

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Appendix A Ordering Information

A

ppendix A

PROCOTYL® L Cups

PLPCKITA

Catalog# Cup_Size Inner_Ø Group Equatorial_Diameter Sph. R Height

PHA06202 42* 35 A 44 21.5 20.5 PHA06204 44 37 B 46 22.5 21.5 PHA06206 46 39 C 48 23.5 22.5 PHA06208 48 39 C 50 24.5 23.5 PHA06210 50 41 D 52 25.5 24.5 PHA06212 52 44 E 54 26.5 25.5 PHA06214 54 44 E 56 27.5 26.5 PHA06216 56 48 F 58 28.5 27.5 PHA06218 58 48 F 60 29.5 28.5 PHA06220 60 52 G 62 30.5 29.5 PHA06222 62 52 G 64 31.5 30.5 PHA06224 64 52 G 66 32.5 31.5 PHA06226 66 52 G 68 33.5 32.5 PHA06228 68 52 G 70 34.5 33.5 With

HA Coating CupSize InnerØ Group EquatorialDiameter Sph. R Height

PHA06252 42* 35 A 44 21.5 20.5 PHA06254 44 37 B 46 22.5 21.5 PHA06256 46 39 C 48 23.5 22.5 PHA06258 48 39 C 50 24.5 23.5 PHA06260 50 41 D 52 25.5 24.5 PHA06262 52 44 E 54 26.5 25.5 PHA06264 54 44 E 56 27.5 26.5 PHA06266 56 48 F 58 28.5 27.5 PHA06268 58 48 F 60 29.5 28.5 PHA06270 60 52 G 62 30.5 29.5 PHA06272 62 52 G 64 31.5 30.5 PHA06274 64 52 G 66 32.5 31.5 PHA06276 66 52 G 68 33.5 32.5 PHA06278 68 52 G 70 34.5 33.5

* Does not possess screw / dome hole plugs

Ordering

Information

PROCOTYL® L HA Coated Cups

PLHAKITA

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17 Appendix A Ordering Information

RIM-LOCK Ceramic Liners

CERAKITB

Catalog # Group _Diam.Head Cup Size

PHA04502 A 28 42 PHA04504 B 44 PHA04506 C 32 46 - 48 PHA04508 D 50 PHA04510 E 36 52 - 54 PHA04512 F 56 - 58 PHA04514 G 60 - 62 - 64 - 66 - 68

RIM-LOCK Metal Liners

METAKITB

150 Lip 00 Lip Group _Diam.Head Cup Size PE at the dome_{in mm} PE at 450_{in mm}

PHA04654 PHA04604 B 28 44 5.4 6.7 PHA04656 PHA04606 C 46 - 48 5.9 7.2 PHA04658 PHA04608 D 32 50 5.4 6.5 PHA04660 PHA04610 E 52 - 54 6.4 7.6 PHA04662 PHA04612 F 36 56 - 58 5.9 7.4 PHA04664 PHA04614 G 60 - 62 - 64 _{66 - 68} 7.9 9.9

RIM-LOCK X-linked Poly Liners

XLINKITB

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Titanium Cancellous Screws 6.5mm Ø / 3.5mm hex

Catalog # Length Catalog # Length

18080300 15mm 18080304 35mm 18080301 20mm 18080305 40mm 18080302 25mm 18080306 45mm 18080303 30mm 18080307 50mm Catalog # Size 26000017 28mm - 3.5 26000018 28mm + 0.0 26000019 28mm + 3.5 26000020 28mm + 7.0 26000021 32mm - 3.5 26000022 32mm + 0.0 26000023 32mm + 3.5 26000024 32mm + 7.0 26000025 36mm - 3.5 26000026 36mm + 0.0 26000027 36mm + 3.5 26000028 36mm + 7.0

CoCr Super Finish Head

SUFIKITA Catalog # Size PHA04402 28mm - 3.5 PHA04404 28mm + 0.0 PHA04406 28mm + 3.5 PHA04408 32mm - 4.0 PHA04410 32mm + 0.0 PHA04412 32mm + 4.0 PHA04414 36mm - 3.5 PHA04416 36mm + 0.0 PHA04418 36mm + 3.5

BIOLOX Delta Head

CERAKITA

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19 Appendix B Instrumentation

Instrumentation

APH04400

_A

ppendix B

Cup Impactor Orientation Rod

Trial Cup Impactor Adapter Cup Impactor Adapter Group A - B - C - D - E - F - G

Trial Acetabular Cup

Sizes 42- 68 RIM-LOCK Trial Liners 150 Lip

Tommy Bar Ceramic / Metal

Liner Extractor RIM-LOCK Trial Liners

00 Lip

Universal handle for liners

positioner Final Cup Impactor Tip Ceramic and Metal Liner positioners Ø 28 - 32 - 36 Poly Liner Positioners

Ø 28 - 32 - 36 Poly Lipped Liner Positioners

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Appendix B Instrumentation

Ratchet screwdriver handle with quick

connection Screw holder

Flexible screw depth gauge Fixed angle drill guide

3.2mm / 4.5mm Flexible drill / screw

shaft Hex driver shaft

straight solid 3.5mm

Universal joint 3.5mm hex driver

shaft

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Catalog # Description Quantity

LNG2CL01E X-ray templates 15% magnification 00 lip liner 1 LNG2CL02E X-ray templates 15% magnification150 lip liner 1

FNA00470 Sterilization container 1 (empty) 1

FNA00473 Lid for tray 1 1

APA09301 Cup impactor 1

APA09302 Orientation rod 2

APA09310 Trial cup impactor adapter 1

APA09303 APA09304 APA09305 APA09306 APA09307 APA09308 APA09309

Cup impactor adapter group A Cup impactor adapter group B Cup impactor adapter group C Cup impactor adapter group D Cup impactor adapter group E Cup impactor adapter group F Cup impactor adapter group G

1 1 1 1 1 1 1 APA09322 APA09324 APA09326 APA09328 APA09330 APA09332 APA09334 APA09336 APA09338 APA09340 APA09342 APA09344 APA09346 APA09348

Trial acetabular cup size 42 Trial acetabular cup size 44 Trial acetabular cup size 46 Trial acetabular cup size 48 Trial acetabular cup size 50 Trial acetabular cup size 52 Trial acetabular cup size 54 Trial acetabular cup size 56 Trial acetabular cup size 58 Trial acetabular cup size 60 Trial acetabular cup size 62 Trial acetabular cup size 64 Trial acetabular cup size 66 Trial acetabular cup size 68

1 1 1 1 1 1 1 1 1 1 1 1 1 1

PPB31902 Tommy bar 1

PPR68030 Universal handle for:Poly standard / lipped liner positioner Ceramic / metal liner positioner

1 PPR68038

APA04565 APA09313

Ceramic / metal liner positioner ø 28 Ceramic / metal liner positioner ø 32 Ceramic / metal liner positioner ø 36

1 1 1

Note: Reamers are not included in the PROCOTYL® L instruments set.

PROCOTYL® L Instruments

APH04400

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APA07054 APA07056 APA09311

Poly liner positioner ø 28 Poly liner positioner ø 32 Poly liner positioner ø 36

1 1 1 APA07060 APA07062 APA09312

Poly lipped liner positioner ø 28 Poly lipped liner positioner ø 32 Poly lipped liner positioner ø 36

1 1 1 APA09382 APA09384 APA09386 APA09388 APA09390 APA09392 APA09394 APA09396 APA09398

RIM-LOCK Trial liner 00 lip 28 Group A RIM-LOCK Trial liner 00 lip 28 Group B RIM-LOCK Trial liner 00 lip 28 Group C RIM-LOCK Trial liner 00 lip 32 Group C RIM-LOCK Trial liner 00 lip 32 Group D RIM-LOCK Trial liner 00 lip 32 Group E RIM-LOCK Trial liner 00 lip 36 Group E RIM-LOCK Trial liner 00 lip 36 Group F RIM-LOCK Trial liner 00 lip 36 Group G

1 1 1 1 1 1 1 1 1 APA09364 APA09366 APA09368 APA09370 APA09372 APA09374

RIM-LOCK Trial liner 150 lip 28 Group B RIM-LOCK Trial liner 150 lip 28 Group C RIM-LOCK Trial liner 150 lip 32 Group D RIM-LOCK Trial liner 150 lip 32 Group E RIM-LOCK Trial liner 150 lip 36 Group F RIM-LOCK Trial liner 150 lip 36 Group G

1 1 1 1 1 1

APA09314 Ceramic / Metal liner extractor 1

PPR68070 Final cup impactor tip 1

4820SH0000 Screw holder 1

8400DG01 Fixed angle drill guide 3.2mm / 4.5mm 1

8400FD01 Flexible drill / screw shaft 1

8400FD05 8400FD06 8400FD08 8400FD09 Drill bit 3.2 x 25mm Drill bit 3.2 x 35mm Drill bit 4.5 x 25mm Drill bit 4.5 x 35mm 1 1 1 1 2002-QCRH Ratchet screwdriver handle with quick _connection 1 8400SD03 Universal joint 3.5mm hex driver shaft 1 8400SD06 Hex driver shaft straight solid 3.5mm 1

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Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone 800.238.7188 toll-free www.wmt.com

Wright Medical EMEA Krijgsman 11

1186 DM Amstelveen The Netherlands 00.31.20.545.0100 phone www.wmt-emea.com

™Trademarks and ®Registered marks of Wright Medical Technology, Inc. Patents pending.

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PROFEMUR® Total Hip System

PROCOTYL® O

Acetabular Cup System

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PROFEMUR® Total Hip System

PROCOTYL

®

_{O Acetabular Cup System}

Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects.

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PROCOTYL® O Acetabular Cup System

Design

Rationale

The PROCOTYL® O acetabular component is a hemi-spherical design. It has a flattened polar region to facilitate easier seating of the component.

Initial stability is obtained by the scratch-fit of the plasma sprayed porous titanium layer in combination with the 12 equatorial fins. The porosity of the 400 micron titanium layer varies between 20 and 65%, thereby providing a well-accepted matrix for bone in-growth, resulting in long term fixation. In case initial stability is limited up to 3 screws can be used for extra fixation. Components are available in 2 styles: with and without an additional layer of hydroxylapatite with an average thickness 80 micron.

Intra-operative flexibility - PROCOTYL® O Acetabular Cup System is the only system on the market which accepts ceramic, metal and A-Class® advanced X-linked poly liners. Liners are securely locked by the RIM-LOCK fixation system and the 18° internal taper.

PROCOTYL® O acetabular components are recommended to be used in conjunction with PROFEMUR® femoral components and their unique Modular Neck system. Modular Necks allow for optimal restoration of patient’s original hip biomechanics. Independent of the femoral shaft position, it allows control over leg length, offset, alignment and version.

The 3 in-line screw holes are positioned away from the dome of the cup to achieve a maximum lever arm, optimal purchase in the illiac wing and thereby maximizing stability. The screws have a 200 freedom of direction. X-ray courtesy of Dr. E. Tozzi, Pisa-Calambrone, Italy

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3 PROCOTYL® O Acetabular Cup System

Design Features of the

PROCOTYL® O Cup

Ordering Information

Templates PTC4CL01E 00 Lip Liner PTC4CL02E 150 Lip Liner Surgical

Technique EH003-807E

Instruments APH04400

Implants POPCKITA non coated cups POHAKITA HA-coated cups CERAKITB ceramic liners XLINKITB poly liners METAKITB metal liners SUFIKITA metal heads CERAKITA ceramic heads

Secure initial stability

Additional screw fixation

Increase ball bearing diameters 46mm cup - 32mm head 52mm cup - 36mm head Comes in sizes 42 - 68 (2 mm increments) Ceramic liner • Alumina Matrix composite • 00 lip • Standard offset • Taper locking • 28, 32 and 36mm inside diameters Metal liner • Cobalt Chrome • 00 lip • Standard offset • Taper locking • 28, 32 and 36mm inside diameters In-growth surface • 20-65% Porosity – 400 µm thickness • Plasma sprayed Titanium powder Outer geometry • Hemi-spherical - Single radius 180° • 12 Equatorial fins • Flattened dome A-Class® Advanced X-linked Poly liner

• 00 and 150 lip options • 3600 lip position • 28, 32 and 36mm inside diameters

PROCOTYL® O cup

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Chapter 2 Pre-operative Planning

2

Pre-operative

Planning

Pre-operative Planning

Pre-operative assessment of the appropriate size and position of the acetabular component will provide intra-operative guidance for acetabular reaming. A bilateral A/P x-ray of the pelvis will aid in leg length and offset assessment and management. Leg length discrepancies should be determined pre-operatively and addressed intra-operatively.

Radiographic overlays for the PROCOTYL® O Acetabular Cup System are available in 15% magnification, with 0° or 15° liners. To determine the acetabular cup size and position, place the overlay outline at approximately 45° of abduction and the center of rotation within the anatomic center of the acetabular image.

Note: The use of a magnification marker will aid in determining the x-ray magnification.

Caution: Pre-operative templating is intended for estimation purposes only. Final component size and position should be determined intra-operatively.

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3

Surgical

Technique

Preparation of the Acetabulum

Osteophytes should be removed to enable assessment of the true acetabular rim. Reaming should be sequential and start with the smallest reamer that conforms to the acetabular cavity. Reaming to the edge of the reamer will mimic a full

hemisphere. Gradually enlarge the acetabulum by reaming articular cartilage until a continuous surface of cancellous bone is exposed.

Note: PROCOTYL® O shells come in 2mm increments, ranging from 42 - 68 mm.

Ream to the size of the final component will provide a 0.5mm overall press-fit.

Reaming depth, acetabular shape and size can be confirmed by using a trial shell sizer.

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PROCOTYL® O Cup Reaming Guide

For hemispherical press-fit of 1mm

ream to 2mm ream to PROCOTYL® O size 42 42mm 41mm PROCOTYL® O size 44 44mm 43mm PROCOTYL® O size 46 46mm 45mm PROCOTYL® O size 48 48mm 47mm PROCOTYL® O size 50 50mm 49mm PROCOTYL® O size 52 52mm 51mm PROCOTYL® O size 54 54mm 53mm PROCOTYL® O size 56 56mm 55mm PROCOTYL® O size 58 58mm 57mm PROCOTYL® O size 60 60mm 59mm PROCOTYL® O size 62 62mm 61mm PROCOTYL® O size 64 64mm 63mm PROCOTYL® O size 66 66mm 65mm PROCOTYL® O size 68 68mm 67mm

A trial shell adapter (APA09310) is put onto the tip of the cup inserter instrument before mounting the trial shell which corresponds with the final reamer. The adapter is kept in place by a locking ring; the shell is fixed by turning the central rod of the cup inserter clockwise. Following trialing the shell and adapter are to be removed from the cup inserter instrument.

Note: The trial shells are equal in dimensions to the corresponding final implant but without fins or plasma coating.

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Inserting the Shell

A full series of cup size dedicated adapters (APA09303 - APA09309) is available in the instrument kit. The adapter corresponding to the preferred cup size is put onto the tip of the cup impactor, followed by the acetabular component. The pins on both arms of the adapter are to match the dimples in the face of the cup. This method of stabilization provides full control over the position of the cup at impaction.

Note: The face of the shell has three laser marked lines that correspond to the screw hole locations. Position the marks between the plane of the anterior-superior and the anterior-inferior iliac spine.

Seat the shell with a series of firm mallet blows on the end of the impactor.

Once seated, the cup inserter instrument can be removed by turning the central rod counter-clockwise. Complete seating of the implant can be confirmed through the apical hole.

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8

Inserting the Shell (continued)

Screw placement can begin once the shell component is securely positioned and the impactor is removed.

In case re-positioning of the cup is required, the cup inserter instrument can be mounted again and the cup can be removed, re-oriented and re-implanted. If a deeper seating is preferred, it might help to attach the cup impactor tip to the universal rod and use this as a cup inserter device. The flat of the cup impactor tip is to be positioned properly against the flat of the cup dome before hitting the universal handle with a hammer.

Two alignment rods (APA09302) can be mounted on the inserter to aid in positioning the implant at 45° of abduction and 15° of ante-version. Position the longitudinal guide rod 90° to the midline of the patient to position the shell at 45°. Position the transverse guide rod parallel to the midline of the patient as this will place the implant at 15° of inclination. Positions given are based on a posterior approach / affected side up.

Note: The patient might have shifted during surgery and the alignment rods can therefore only be seen as an orientation guide.

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9

Screw Placement and Fixation

PROCOTYL® O shells are designed to allow additional fixation by means of screws; the shells come pre-plugged except for size 42 mm shell. Determine screw location and select a suitable length drill bit. Drill bits are provided in 3.2 and 4.5mm diameters; the drill guide is also available in 3.2 and 4.5mm diameters. Insert the drill into the guide and carefully drill through the acetabular cortex.

Use the screw depth gauge to determine the appropriate screw length.

Caution: Due to intra-pelvic vascular structures, screw placement in the medial aspect of the acetabulum must be carefully considered.

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10

Grasp the screw head with the screw holding forceps and utilize the hex screwdiver to orient and fixate the screw. Centralize the screw to protect the threads from abrasion and assures countersinking of the screw head within the hole. Release the screw holding forceps to allow for countersinking of the screw head, which allows full seating of the prosthetic liner. Full seating of the liner can be confirmed with the use of a trial liner prior to impacting the prosthetic liner, or by manually examining the inner surface of the shell to check if the screw head is proud.

Caution: To ensure proper prosthetic liner seating in the shell, all screw heads must be seated below the inner surface of the shell. Full and unobstructed seating is crucial to implant fit and longevity.

Trial Liner Placement

Trial liners that match the prosthetic implant are available to evaluate the optimum position of the implant and the preferred liner. With the prosthetic shell secured within the reamed cavity, insert the trial liner into the shell.

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11

Note: Care should be taken to avoid neck / liner impingement in all potential positions. The acetabular component should be repositioned as necessary to relieve impingement. Alternatively, a change of modular neck could possibly solve the impingement phenomenon.

Position the trial liner in the desired orientation and secure it with the captured screw using a 3.5mm hex screwdriver. If a lipped liner is to be used, a reference mark should be made on the acetabulum to aid in proper positioning of the final liner implant.

Note: The hard-on-hard liners allow for larger bearing diameters than polyethylene liners, which causes an ‘overlap’ in the femoral head size range. The difference between group C 28/32 and group E 32/36 is made clear by trial liner colour coding.

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12

Dome Plug Insertion

After a satisfactory trial reduction and assessment of joint stability, seal the dome hole with the special plug.

Whereas the screw hole plugs are pre-mounted, the dome hole plug comes separate in the packaging (except size 42 mm). The plug can be attached to the tip of the straight hex driver shaft and will be kept in place by the retaining mechanism.

Note: The dome hole plug should not be inserted until a trial reduction with the trial liner is completed.

Liner Placement

Assemble a 0° or 15° lipped liner positioner to the impactor handle. Place the liner and hold it by hand.

Place the liner in the selected position making sure the face of the liner is parallel to the face of the shell. Apply a series of firm mallet blows to fully seat the liner, followed by removal of the inserter.

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Caution: Improper position and impaction of the liner will damage the liner.

Hard-on-hard bearing liners are inserted by hand. The inserter handle with mounted liner positioner is applied and fixation is achieved by some light taps.

Note: Make sure that the rim of the liner is circumferentially flush with the face of the shell before final seating.

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14

X-linked Poly Liner Removal

To remove a poly liner, a flexible drill bit with an acetabular drill guide is used to drill a hole slightly off center from the liner apex. Using a 3.5mm hex screwdriver, a cancellous screw (20mm) is then advanced into the drilled hole until the liner is removed.

Ceramic / Metal Liner Removal

To remove a ceramic or metal liner a liner extractor is used. Position the tip of the liner extractor in a dimple in the face of the cup and apply some short mallet strokes. This results in a counteraction loosening the liner; repetitive action might be necessary.

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15

Technique

Overview

Chapter 3 Surgical Technique 1. Preparation of the Acetabulum - reaming 4. Screw Placement - drilling 7.Trial Liner Insertion 1. Preparation of the Acetabulum - trial shell to check reamed cavity 3. Inserting the Shell 5. Screw Placement - fixation 8. Dome Plug Insertion 6. Trial Liner Evaluation 9. Liner Placement Liner Options: • XLPE 00 and 150 • Ceramic • Metal

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16

A

ppendix A

PROCOTYL® O Cups

POPCKITA

* Does not possess screw / dome hole plugs

Ordering

Information

PROCOTYL® O HA Coated Cups

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17 Appendix A Ordering Information

RIM-LOCK Ceramic Liners

CERAKITB

RIM-LOCK Metal Liners

METAKITB

RIM-LOCK X-linked Poly Liners

XLINKITB

150 Lip 00 Lip Group _Diam.Head Cup Size PE at the dome_{in mm} PE at 450_{in mm}

PHA04654 PHA04604 B 28 44 5.4 6.7 PHA04656 PHA04606 C 46 - 48 5.9 7.2 PHA04658 PHA04608 D 32 50 5.4 6.5 PHA04660 PHA04610 E 52 - 54 6.4 7.6 PHA04662 PHA04612 F 36 56 - 58 5.9 7.4 PHA04664 PHA04614 G 60 - 62 - 64 _{66 - 68} 7.9 9.9

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18

Titanium Cancellous Screws 6.5mm Ø / 3.5mm hex

Catalog # Length Catalog # Length

18080300 15mm 18080304 35mm 18080301 20mm 18080305 40mm 18080302 25mm 18080306 45mm 18080303 30mm 18080307 50mm Catalog # Size 26000017 28mm - 3.5 26000018 28mm + 0.0 26000019 28mm + 3.5 26000020 28mm + 7.0 26000021 32mm - 3.5 26000022 32mm + 0.0 26000023 32mm + 3.5 26000024 32mm + 7.0 26000025 36mm - 3.5 26000026 36mm + 0.0 26000027 36mm + 3.5 26000028 36mm + 7.0

CoCr Super Finish Head

SUFIKITA Catalog # Size PHA04402 28mm - 3.5 PHA04404 28mm + 0.0 PHA04406 28mm + 3.5 PHA04408 32mm - 4.0 PHA04410 32mm + 0.0 PHA04412 32mm + 4.0 PHA04414 36mm - 3.5 PHA04416 36mm + 0.0 PHA04418 36mm + 3.5

BIOLOX Delta Head

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Instrumentation

APH04400

_A

ppendix B

Cup Impactor Orientation Rod

Trial Cup Impactor Adapter Cup Impactor Adapter Group A - B - C - D - E - F - G

Trial Acetabular Cup

Sizes 42- 68 RIM-LOCK Trial Liners

150 Lip

Tommy Bar Ceramic / Metal

Liner Extractor RIM-LOCK Trial Liners

00 Lip

Universal handle for liners

positioner Final Cup Impactor Tip Ceramic and Metal Liner positioners Ø 28 - 32 - 36 Poly Liner Positioners

Ø 28 - 32 - 36 Poly Lipped Liner Positioners

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20

Ratchet screwdriver handle with quick

connection Screw holder

Flexible screw depth gauge Fixed angle drill guide

3.2mm / 4.5mm Flexible drill / screw

shaft Hex driver shaft

straight solid 3.5mm Universal joint 3.5mm hex driver

shaft

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PTC4CL01E X-ray templates 15% magnification 00 lip liner 1

PTC4CL02E X-ray templates 15% magnification150 lip liner 1

APA09301 Cup impactor 1

APA09302 Orientation rod 2

APA09310 Trial cup impactor adapter 1

APA09303 APA09304 APA09305 APA09306 APA09307 APA09308 APA09309

Cup impactor adapter group A Cup impactor adapter group B Cup impactor adapter group C Cup impactor adapter group D Cup impactor adapter group E Cup impactor adapter group F Cup impactor adapter group G

1 1 1 1 1 1 1 APA09322 APA09324 APA09326 APA09328 APA09330 APA09332 APA09334 APA09336 APA09338 APA09340 APA09342 APA09344 APA09346 APA09348

Trial acetabular cup size 42 Trial acetabular cup size 44 Trial acetabular cup size 46 Trial acetabular cup size 48 Trial acetabular cup size 50 Trial acetabular cup size 52 Trial acetabular cup size 54 Trial acetabular cup size 56 Trial acetabular cup size 58 Trial acetabular cup size 60 Trial acetabular cup size 62 Trial acetabular cup size 64 Trial acetabular cup size 66 Trial acetabular cup size 68

1 1 1 1 1 1 1 1 1 1 1 1 1 1

PPB31902 Tommy bar 1

PPR68030 Universal handle for:Poly standard / lipped liner positioner Ceramic / metal liner positioner

1 PPR68038

APA04565 APA09313

Ceramic / metal liner positioner ø 28 Ceramic / metal liner positioner ø 32 Ceramic / metal liner positioner ø 36

1 1 1

Note: Reamers are not included in the PROCOTYL® O instruments set.

PROCOTYL® O Instruments

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22

APA07054 APA07056 APA09311

Poly liner positioner ø 28 Poly liner positioner ø 32 Poly liner positioner ø 36

1 1 1 APA07060 APA07062 APA09312

Poly lipped liner positioner ø 28 Poly lipped liner positioner ø 32 Poly lipped liner positioner ø 36

1 1 1 APA09382 APA09384 APA09386 APA09388 APA09390 APA09392 APA09394 APA09396 APA09398

RIM-LOCK Trial liner 00 lip 28 Group A RIM-LOCK Trial liner 00 lip 28 Group B RIM-LOCK Trial liner 00 lip 28 Group C RIM-LOCK Trial liner 00 lip 32 Group C RIM-LOCK Trial liner 00 lip 32 Group D RIM-LOCK Trial liner 00 lip 32 Group E RIM-LOCK Trial liner 00 lip 36 Group E RIM-LOCK Trial liner 00 lip 36 Group F RIM-LOCK Trial liner 00 lip 36 Group G

1 1 1 1 1 1 1 1 1 APA09364 APA09366 APA09368 APA09370 APA09372 APA09374

RIM-LOCK Trial liner 150 lip 28 Group B RIM-LOCK Trial liner 150 lip 28 Group C RIM-LOCK Trial liner 150 lip 32 Group D RIM-LOCK Trial liner 150 lip 32 Group E RIM-LOCK Trial liner 150 lip 36 Group F RIM-LOCK Trial liner 150 lip 36 Group G

1 1 1 1 1 1

APA09314 Ceramic / Metal liner extractor 1

PPR68070 Final cup impactor tip 1

4820SH0000 Screw holder 1

8400DG01 Fixed angle drill guide 3.2mm / 4.5mm 1

8400FD01 Flexible drill / screw shaft 1

8400FD05 8400FD06 8400FD08 8400FD09 Drill bit 3.2 x 25mm Drill bit 3.2 x 35mm Drill bit 4.5 x 25mm Drill bit 4.5 x 35mm 1 1 1 1 2002-QCRH Ratchet screwdriver handle with quick _connection 1

8400SD03 Universal joint 3.5mm hex driver shaft 1

8400SD06 Hex driver shaft straight solid 3.5mm 1

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23

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24

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Wright Medical EMEA Krijgsman 11

1186 DM Amstelveen The Netherlands 00.31.20.545.0100 phone www.wmt-emea.com

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PROCOTYL® C

Cemented Acetabular Cup System

• Hemispherical design

• Circumferential fixation grooves

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1

Design

Overview

Pr

efac

e

PROCOTYL® C Cemented Acetabular Cup System

PROCOTYL® C

Cemented Acetabular Cup System

» Hemispherical design

» A-Class™ Advanced Cross-Linked Poly » Circumferential fixation grooves » Radiological marker

» Large range of motion

PROCOTYL® C

Implant CupSize HeadSize

PHA06602 46 32 PHA06604 48 36 PHA06606 50 36 PHA06608 52 36 PHA06610 54 36 PHA06612 56 36 PHA06614 58 36 PHA06616 60 36 PHA06618 62 36 PHA06620 64 36

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1 chapt

er

Surgical

Technique

2

Chapter 1 Surgical Technique

Preparation of the acetabulum

• Following the preferred surgical exposure, the acetabular cavity is reamed with hemispherical reamers, preferably with 2 mm increments.

• The direction of the reaming is supero-posterially. Avoid over reaming. Increase reamer size until contact is made with the anterior and posterior wall.

• Multiple small anchoring holes drilled into the subchondral bone will enhance fixation.

• The acetabular component and acetabular trial component size match the size of the last acetabular reamer.

• Fix the trial cup to the inserter handle.

• Slide the aiming device over the handle of the inserter instrument and screw the anteversion rod into the left of the right screw hole - operated size depending.

• Insert the trial cup into the acetabulum. With the aiming device as illustrated. The rim of the trial cup will be orientated at 200 of anteversion and 450 of inclination | Figure 1

• Checkthat the edge of the cup is now flush with or within the acetabular rim

| Figure 2

Figure 1

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3

Chapter 1 Surgical Technique

Cementing of the acetabular component

• After trial insertion, the acetabulum is cleaned

• The cup inserter handle must be prepared for cup placement. Screw the cup pusher head onto the instrument, followed by the 32 or 36 mm hemispherical positioning hat | Figure 3

• Depending on the surgeon’s preference for a specific cement mantle thickness a cup size is chosen. The sizes of the cups are in nominal value.

• The bone cement is handled in the preferred manner and the cement is applied into the acetabulum.

• The cup is inserted into the doughy cement mass and pushed down to the preferred level | Figure 4. Excess cement will escape when the cup is driven home and needs to be removed.

• Hold the cup stable and remove the inserter.

• Remove the positioning hat and reapply the inserter into the cup | Figure 5

• Hold still and maintain applying pressure onto the cup until the cement has fully set.

Note: The technique shown above illustrates a posterior approach.

Figure 4 Figure 3

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chapt

er

Chapter 2 Ordering Information

2 Ordering

Information

4

PROCOTYL® C Implants

» Material: A-Class™ Advanced Cross -Linked Poly

» Sterilization: Ethylene Oxide

» Packaging: Double blister

Catalogue # Cup Size Head Size

PHA06602 46 32 PHA06604 48 36 PHA06606 50 36 PHA06608 52 36 PHA06610 54 36 PHA06612 56 36 PHA06614 58 36 PHA06616 60 36 PHA06618 62 36 PHA06620 64 36

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chapt

er

Chapter 3 Instrumentation 5

3 PROCOTYL® C Instruments

APH04500

Catalogue # Description Quantity

APA11002 Cup Inserter Handle 1 APA11004 Cup Inserter Handle Guide 1 APA11006 Orientation rod 1 APA11008 Cup positioning hat ø 32 1 APA11010 Cup positioning hat ø 36 1 APA11012 Cup pusher head ø 26 1 APA11016 APA11018 APA11020 APA11022 APA11024 APA11026 APA11028 APA11030 APA11032 APA11034 APA11036 APA11038

PROCOTYL® C Trial Cup Size 46 PROCOTYL® C Trial Cup Size 48 PROCOTYL® C Trial Cup Size 50 PROCOTYL® C Trial Cup Size 52 PROCOTYL® C Trial Cup Size 54 PROCOTYL® C Trial Cup Size 56 PROCOTYL® C Trial Cup Size 58 PROCOTYL® C Trial Cup Size 60 PROCOTYL® C Trial Cup Size 62 PROCOTYL® C Trial Cup Size 64 PROCOTYL® C Trial Cup Size 66 PROCOTYL® C Trial Cup Size 68

1 1 1 1 1 1 1 1 1 1 1 1 PCC1CL02E PROCOTYL® C Templates 15%

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Wright Medical EMEA

Krijgsman 11 1186 DM Amstelveen The Netherlands 00.31.20.545.0100 phone www.wmt-emea.com

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MH447-809

Wright Medical Technology, Inc.

5677 Airline Road Arlington, TN 38002 901.867.9971 phone 800.238.7188 toll-free www.wmt.com

Wright Medical EMEA

Krijgsman 11 1186 DM Amstelveen The Netherlands 011.31.20.545.0100 www.wmt-emea.com

Undetectable Free Radicals

• Wright’s A-CLASS® Polyethylene manufacturing process utilizes

remelting to quench free radicals and increases cross-link density.

○ Cross-linking process balances improved wear and

strength properties.

○ Remelting removes more free radicals than

melt-annealing3

No Oxidation

• The A-CLASS® fi nishing process utilizes Ethylene Oxide (EtO)

sterilization to maintain the oxidative stability of polyethylene.

○ EtO does not add free radicals to polyethylene1

○ EtO sterilization preserves oxidative stability in the material

Oxidation Analysis of Aged Wear Test Components:

• Oxidation index was measured on 3 A-CLASS® 28mm liners (5 million cycles wear)

○ Components were aged in air for over 3 years

○ Oxidation profi les conducted at high stress points.

• No detectable oxidation!2

A-CLASS

®

Cross-Linked Polyethylene

Wear Less.

92% or Greater Reduction in Wear

Compared to Conventional Polyethylene

400 300 200 100 0

W

ear (mm

3

)

0 1 2 3 4 5

Million Cycles

Conventional Poly

A-CLASS® Cross-Link Polyethylene

Laboratory testing confi rms a 92% reduction in wear or greater for A-CLASS® Cross-Linked Polyethylene compared with Wright conventional Polyethylene (Data on fi le at Wright)

1. Kurtz, CORR, Vol 453: 47-57. 2. Data on fi le at Wright.

3. Gomez-Barrena, Acta Orthopaedica, Vol. 79, No. 6, Pages 832-840.

PROCOTYL L. Acetabular Cup System

PROCOTYL® L

Acetabular Cup System

Contents

PROCOTYL

L Acetabular Cup System

1

chapt

er

Design

Rationale

Design Features of the

PROCOTYL® L Cup

chapt

er

2

Pre-operative

Planning

Pre-operative Planning

chapt

er

3

Surgical

Technique

Preparation of the Acetabulum

PROCOTYL® L Cup Reaming Guide

Inserting the Shell

Inserting the Shell

Screw Placement and Fixation

Trial Liner Placement

Dome Plug Insertion

Liner Placement

X-linked Poly Liner Removal

Ceramic / Metal Liner Removal

Technique

Overview

A

ppendix A

PROCOTYL® L Cups

Ordering

Information

PROCOTYL® L HA Coated Cups

RIM-LOCK Ceramic Liners

RIM-LOCK Metal Liners

RIM-LOCK X-linked Poly Liners

Titanium Cancellous Screws 6.5mm Ø / 3.5mm hex

CoCr Super Finish Head

BIOLOX Delta Head

Instrumentation

APH04400

A

ppendix B

PROCOTYL® L Instruments

APH04400

PROCOTYL® O

Acetabular Cup System

Contents

PROCOTYL

O Acetabular Cup System

1

chapt

er

Design

Rationale

Design Features of the

PROCOTYL® O Cup

chapt

er

2

Pre-operative

Planning

Pre-operative Planning

chapt

er

3

Surgical

Technique

Preparation of the Acetabulum

PROCOTYL® O Cup Reaming Guide

Inserting the Shell

_{L Acetabular Cup System}

_A

_{O Acetabular Cup System}

_A