acetabular cup system - mediservis · contents 1 design rationale design features of the procotyl®...

PROCOTYL® LAcetabular Cup System

S U R G I C A L T E C H N I Q U E

Contents

1

Design Rationale

Design Features of the PROCOTYL® L Cup

Pre-operative Planning

Surgical Technique PROCOTYL® L Cup

Preparation of the Acetabulum

PROCOTYL® L Reaming Guide

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

Ordering Information

PROCOTYL® L Cups

RIM-LOCK Ceramic Liners

RIM-LOCK Metal Liner

RIM-LOCK X-linked Poly Liner

BIOLOX Delta Heads

CoCr Super Finish Heads

Screws

Instrumentation

Chapter 1 2

3

Chapter 2 4

Chapter 3 5

5

6

7

9

10

12

12

14

14

15

Appendix A 16

16

17

17

17

18

18

18

Appendix B 19

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.

1chapter

2PROCOTYL® 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-LOCK locking 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

3PROCOTYL® L Acetabular Cup System

Design Features of the PROCOTYL® L Cup


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 stabilityAdditional screw fixation

Increase ball bearing diameters46mm cup - 32mm head52mm 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 surfaceSintered Titanium beads30% 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 accommodates 3 types of liners

chap

ter

4Chapter 2 Pre-operative Planning

2Pre-operative Planning

Pre-operative PlanningPre-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.

chap

ter

5Chapter 3 Surgical Technique

3Surgical Technique

Preparation of the AcetabulumOsteophytes 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.

6

PROCOTYL® L Cup Reaming Guide

For equatorial press-fit of 1mm

ream to

2mm

ream to

PROCOTYL® L size 42 43mm 42mm














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.

Chapter 3 Surgical Technique


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.

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.


9

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.



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 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.

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.


12

Dome Plug InsertionAfter 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 PlacementAssemble 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.



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.


X-linked Poly Liner RemovalTo 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 RemovalTo 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.

15

Technique Overview


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

16Appendix A Ordering Information

App

endi

x A

PROCOTYL® L CupsPLPCKITA

Catalog# CupSize

InnerØ 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



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



PROCOTYL® L HA Coated CupsPLHAKITA


RIM-LOCK Ceramic LinersCERAKITB

Catalog # Group HeadDiam. Cup Size

PHA04502 A28

42

PHA04504 B 44

PHA04506 C32

46 - 48

PHA04508 D 50

PHA04510 E

36

52 - 54

PHA04512 F 56 - 58

PHA04514 G 60 - 62 - 64 - 66 - 68

RIM-LOCK Metal LinersMETAKITB


PHA04702 A28

42

PHA04704 B 44

PHA04706 C32

46 - 48

PHA04708 D 50

PHA04710 E

36

52 - 54

PHA04712 F 56 - 58

PHA04714 G 60 - 62 - 64 - 66 - 68

150 Lip 00 Lip Group HeadDiam. Cup Size PE at the dome

in mmPE at 450

in mm

PHA04654 PHA04604 B28

44 5.4 6.7

PHA04656 PHA04606 C 46 - 48 5.9 7.2

PHA04658 PHA04608 D32

50 5.4 6.5

PHA04660 PHA04610 E 52 - 54 6.4 7.6

PHA04662 PHA04612 F36

56 - 58 5.9 7.4

PHA04664 PHA04614 G 60 - 62 - 64 66 - 68 7.9 9.9

RIM-LOCK X-linked Poly LinersXLINKITB


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

19Appendix B Instrumentation

Instrumentation APH04400

App

endi

x 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 / MetalLiner Extractor

RIM-LOCK Trial Liners00 Lip

Universal handle for liners

positioner

Final Cup Impactor Tip

Ceramic and Metal

Liner positionersØ 28 - 32 - 36

Poly Liner PositionersØ 28 - 32 - 36

Poly LippedLiner Positioners

Ø 28 - 32 - 36


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

Drill bits


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














1

1

1

1

1

1

1

1

1

1

1

1

1

1



PPB31902 Tommy bar 1

PPR68030Universal handle for:Poly standard / lipped liner positionerCeramic / metal liner positioner

1

PPR68038

APA04565

APA09313

Ceramic / metal liner positioner ø 28



1

1

1

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

PROCOTYL® L Instruments

APH04400



APA07054

APA07056

APA09311

Poly liner positioner ø 28



1

1

1

APA07060

APA07062

APA09312

Poly lipped liner positioner ø 28



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 D

RIM-LOCK Trial liner 00 lip 32 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







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




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

8400SG01 Flexible screw depth gauge 1

23

Notes

24

Notes

Wright Medical Technology, Inc.5677 Airline RoadArlington, TN 38002901.867.9971 phone800.238.7188 toll-freewww.wmt.com

Wright Medical EMEAKrijgsman 111186 DM AmstelveenThe Netherlands00.31.20.545.0100 phonewww.wmt-emea.com

™Trademarks and ®Registered marks of Wright Medical Technology, Inc. Patents pending.©2010 Wright Medical Technology, Inc. All Rights Reserved. EH002-807E Rev 04

PROFEMUR® Total Hip System

PROCOTYL® OAcetabular Cup System

S U R G I C A L T E C H N I Q U E


Contents

1

Design Rationale

Design Features of the PROCOTYL® O Cup

Pre-operative Planning

Surgical Technique PROCOTYL® O Cup

Preparation of the Acetabulum

PROCOTYL® O Reaming Guide

Inserting the Shell

Screw Placement and Fixation


Dome Plug Insertion

Liner Placement

X-linked Poly Liner Removal

Ceramic / Metal Liner Removal

Technique Overview


PROCOTYL® O Cups

RIM-LOCK Ceramic Liners

RIM-LOCK Metal Liner

RIM-LOCK X-linked Poly Liner

BIOLOX Delta Heads

CoCr Super Finish Heads

Screws

Instrumentation

Chapter 1 2

3

Chapter 2 4

Chapter 3 5

5

6

7

9

10

12

12

14

14

15

Appendix A 16

16

17

17

17

18

18

18

Appendix B 19

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.

1chapter

2PROCOTYL® 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

3PROCOTYL® O Acetabular Cup System

Design Features of the PROCOTYL® O Cup


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 stabilityAdditional screw fixation

Increase ball bearing diameters46mm cup - 32mm head52mm 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 accommodates 3 types of liners

chap

ter

4Chapter 2 Pre-operative Planning

2Pre-operative Planning

Pre-operative PlanningPre-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.

chap

ter


3Surgical Technique

Preparation of the AcetabulumOsteophytes 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.

6

PROCOTYL® O Cup Reaming Guide

For hemispherical press-fit of 1mm

ream to

2mm

ream to

PROCOTYL® O size 42 42mm 41mm














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.



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.

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.


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.



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 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.

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.


12

Dome Plug InsertionAfter 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 PlacementAssemble 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.



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.


X-linked Poly Liner RemovalTo 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 RemovalTo 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.

15

Technique Overview


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


App

endi

x A

PROCOTYL® O CupsPOPCKITA

Catalog# CupSize



PHA06402 42* 35 A 43 21.5 20.8

PHA06404 44 37 B 45 22.5 21.8

PHA06406 46 39 C 47 23.5 22.8

PHA06408 48 39 C 49 24.5 23.8

PHA06410 50 41 D 51 25.5 24.8

PHA06412 52 44 E 53 26.5 25.8

PHA06414 54 44 E 55 27.5 26.8

PHA06416 56 48 F 57 28.5 27.8

PHA06418 58 48 F 59 29.5 28.8

PHA06420 60 52 G 61 30.5 29.8

PHA06422 62 52 G 63 31.5 30.8

PHA06424 64 52 G 65 32.5 31.8

PHA06426 66 52 G 67 33.5 32.8

PHA06428 68 52 G 69 34.5 33.8

Catalog# CupSize



PHA06452 42* 35 A 43 21.5 20.8

PHA06454 44 37 B 45 22.5 21.8

PHA06456 46 39 C 47 23.5 22.8

PHA06458 48 39 C 49 24.5 23.8

PHA06460 50 41 D 51 25.5 24.8

PHA06462 52 44 E 53 26.5 25.8

PHA06464 54 44 E 55 27.5 26.8

PHA06466 56 48 F 57 28.5 27.8

PHA06468 58 48 F 59 29.5 28.8

PHA06470 60 52 G 61 30.5 29.8

PHA06472 62 52 G 63 31.5 30.8

PHA06474 64 52 G 65 32.5 31.8

PHA06476 66 52 G 67 33.5 32.8

PHA06478 68 52 G 69 34.5 33.8




PROCOTYL® O HA Coated CupsPOHAKITA


RIM-LOCK Ceramic LinersCERAKITB


PHA04502 A28

42

PHA04504 B 44

PHA04506 C32

46 - 48

PHA04508 D 50

PHA04510 E

36

52 - 54

PHA04512 F 56 - 58

PHA04514 G 60 - 62 - 64 - 66 - 68

RIM-LOCK Metal LinersMETAKITB


PHA04702 A28

42

PHA04704 B 44

PHA04706 C32

46 - 48

PHA04708 D 50

PHA04710 E

36

52 - 54

PHA04712 F 56 - 58

PHA04714 G 60 - 62 - 64 - 66 - 68

RIM-LOCK X-linked Poly LinersXLINKITB

150 Lip 00 Lip Group HeadDiam. Cup Size PE at the dome

in mmPE at 450

in mm

PHA04654 PHA04604 B28

44 5.4 6.7

PHA04656 PHA04606 C 46 - 48 5.9 7.2

PHA04658 PHA04608 D32

50 5.4 6.5

PHA04660 PHA04610 E 52 - 54 6.4 7.6

PHA04662 PHA04612 F36

56 - 58 5.9 7.4

PHA04664 PHA04614 G 60 - 62 - 64 66 - 68 7.9 9.9


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


Instrumentation APH04400

App

endi

x 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 / MetalLiner Extractor

RIM-LOCK Trial Liners00 Lip

Universal handle for liners

positioner

Final Cup Impactor Tip

Ceramic and Metal

Liner positionersØ 28 - 32 - 36

Poly Liner PositionersØ 28 - 32 - 36

Poly LippedLiner Positioners

Ø 28 - 32 - 36


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

Drill bits



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

PTC4CL02E X-ray templates 15% magnification150 lip liner 1



APA09301 Cup impactor 1


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















1

1

1

1

1

1

1

1

1

1

1

1

1

1



PPB31902 Tommy bar 1

PPR68030Universal handle for:Poly standard / lipped liner positionerCeramic / metal liner positioner

1

PPR68038

APA04565

APA09313




1

1

1

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

PROCOTYL® O Instruments

APH04400



APA07054

APA07056

APA09311




1

1

1

APA07060

APA07062

APA09312




1

1

1

APA09382

APA09384

APA09386

APA09388

APA09390

APA09392

APA09394

APA09396

APA09398

RIM-LOCK Trial liner 00 lip 28 Group A









1

1

1

1

1

1

1

1

1

APA09364

APA09366

APA09368

APA09370

APA09372

APA09374







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





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

8400SG01 Flexible screw depth gauge 1

23

Notes

24

Notes

PROCOTYL® CCemented Acetabular Cup System

• Hemisphericaldesign

• Circumferentialfixationgrooves

• Radiologicalmarker

1

Design Overview Pr

efac

e

PROCOTYL® C Cemented Acetabular Cup System

PROCOTYL® CCemented 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

1chap

ter

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

• Check that the edge of the cup is now flush with or within the acetabular rim | Figure 2

Figure 1

Figure 2


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

Figure 5

chap

ter

Chapter 2 Ordering Information

2Ordering 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

chap

ter

Chapter 3 Instrumentation5

3

PROCOTYL® C Instruments

APH04500

Catalogue # Description Quantity

APA11002 Cup Inserter Handle 1

APA11004 Cup Inserter Handle Guide 1


APA11008 Cup positioning hat ø 32 1

APA11010 Cup positioning hat ø 36 1

APA11012 Cup pusher head ø 26 1

APA11016APA11018APA11020APA11022APA11024APA11026APA11028APA11030APA11032APA11034APA11036APA11038

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

111111111111

PCC1CL02E PROCOTYL® C Templates 15%

Instrumentation

™Trademarks and ®Registered marks of Wright Medical Technology, Inc.©2009 Wright Medical Technology, Inc. All Rights Reserved. MH447-809

Wright Medical Technology, Inc.

5677 Airline RoadArlington, TN 38002901.867.9971 phone800.238.7188 toll-freewww.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 below-the-

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 WearCompared to Conventional Polyethylene

400

300

200

100

0

We

ar

(mm

3)

0 1 2 3 4 5Million Cycles

Conventional PolyA-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.

acetabular cup system - mediservis · contents 1 design rationale design features of the procotyl®...

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