design rationale/surgical technique gription tf...1.02 1.00 0.98 0.96 0.94 0.92 0.90 0.88 0.86 0.84...

Design Rationale/Surgical TechniqueGRIPTION® TF

2

Table OFcONTeNTS

Augment, Shim, and Buttress Portfolio .........................................4

GRIPTION® TF Augments System Overview ...................................5

GRIPTION TF Buttress System Overview .........................................6

GRIPTION TF Shim System Overview .............................................7

Advanced Materials .......................................................................8

Advanced Fixation .......................................................................10

Advanced Instrumentation ..........................................................12

Advanced Modularity ..................................................................14

Key Bone Stock and Landmark Considerations ...........................15

Treatment by Defect Algorithm ...................................................16

Pre-operative Planning and Templating .......................................17

GRIPTION TF Surgical Technique ..................................................18

Acetabular Preparation ................................................................19

Implant Insertion .........................................................................22

Buttress Plate/Shim Surgical Technique ........................................27

Ordering Information ..................................................................30

References ...................................................................................36

Filling the gap in acetabular revision surgery

Advanced

InstrumentationAdvanced

Fixation

Advanced

Materials

GRIPTION® TF

DePuy’s GRIPTION TF Acetabular Revision

System is an innovative technology for

addressing bone defects in complex

acetabular revision surgery. It represents

the latest advances in materials, fixation

and instrumentation technologies. Combined

with other elements of the PINNACLE® Hip

Solutions portfolio – including the leading

acetabular cup system and advanced bearing

options – the result is a winning solution to

help restore motion for today’s revision patients.

GRIPTION® TFaugment, Shim,

and buttress Portfolio

advanced geometry provides

increased surface area

for bone contact.

5

GRIPTION® TF augments System Overview

The GRIPTION TF Augments are designed to

act as a defect filling implant in the case of

severe bone loss in the acetabulum.

advanced geometry provides

increased surface area

for bone contact.

Directional screw holes engineered to maximize fixation capability.

Pin holes enhance visualization & assessment of augment fit and suitability.

Screwhole cutaways to optimize fit with PINNacle cup System.

Proprietary TRUebOND™

locking slot to help mechanically secure

augment to acetabular shell.

Tight radius inner diameter on augment to achieve precise fit with cup.

6

GRIPTION® TF buttressSystem Overview

GRIPTION® TF ShimSystem Overview

The GRIPTION TF Buttress is designed to

support the shell in a similar manner as the

Augments, however the Buttress implant

spans the defect in the acetabulum and

is cemented to the shell.

Tapered curved surface for ease of implantation

Screw holes for use with 5.5mm locking/non-locking cortical screws

Screw holes for use with 6.5mm cancellous screws

curved spherical radius to mate with acetabular Shell

Neutral, left and right configurations available for different implant positioning

GRIPTION® TF ShimSystem Overview

The GRIPTION TF Shim implants are designed

to mate with the Buttress to raise the end

of the Buttress when pelvic geometries

require support.

Oversized holes for clearance of locking/ non-locking screws

available in 5, 10 and 15-degree configurations

Advanced


Fixation

Advanced

Materials

advanced Materials

Coefficient of Friction

1.02

1.00

0.98

0.96

0.94

0.92

0.90

0.88

0.86

0.84

0.82GRIPTION TF Augments1

Zimmer™ Augments2

Compressive Yield Strength

250

200

150

100

50

0GRIPTION TF Augments1

Zimmer™ Augments3

Bone-like Modulus of Elasticity

20

15

10

5

0

GPa

MPa

GRIPTION TF1 Zimmer™ 4 CorticalBone

CancellousBone

The GRIPTION TF material is a completely

porous structure made from commercially

pure titanium. It provides a modulus of

elasticity similar to bone, and a coefficient

of friction that allows for initial scratch fit.

Advanced


Fixation

Advanced

Materials

9


1.02

1.00

0.98

0.96

0.94

0.92

0.90

0.88

0.86

0.84


Zimmer™ Augments2


250

200

150

100

50


Zimmer™ Augments3


20

15

10

5

0

GPa

MPa


CancellousBone


1.02

1.00

0.98

0.96

0.94

0.92

0.90

0.88

0.86

0.84


Zimmer™ Augments2


250

200

150

100

50


Zimmer™ Augments3


20

15

10

5

0

GPa

MPa


CancellousBone

10

advanced Fixation

locking Screw OptionGRIPTION TF implants have the ability to use

locking screws to fixate the Augment or

Buttress to the cup and bone. Locking screws

help prevent the screw from becoming loose

and backing out of the Augment and cup.

This helps eliminate the risk of compromising

the fixation as a result of screw migration.

In addition, GRIPTION TF allows surgeons to

implant diverging locking screws for even

stronger fixation to the host bone.

Advanced


Fixation

Advanced

Materials

Advanced


Fixation

Advanced

Materials

cement, cementless or

Hybrid Fixation Options

Prior to the availability of the GRIPTION TF Augments, the only

method of fixating the Augment to the cup was with bone

cement. The introduction of the GRIPTION TF Augments allow

surgeons to select between cementless, cemented and hybrid

options of Augment to cup fixation.

TRUebOND™ cementless Technology

cemented

Hybrid Fixation

advanced Instrumentation

The DePuy GRIPTION TF Revision

System is the only Augment and

Buttress system that provides

specialized instruments to

prepare a customized bone

envelope for the GRIPTION TF

implants. The GRIPTION TF

Revision System allows surgeons

to select two methods of

preparing the acetabular bone

with their choice of modular

or finishing rasps. Featuring

easy connect technology, the

GRIPTION TF system-specific

instruments are user-friendly

and innovative, making them

a valuable complement to

your technique.

Advanced


Fixation

Advanced

Materials

Advanced


Fixation

Advanced

Materials

13

Finishing rasp

Modular rasp

14

advanced Modularity

bantam 38-46mm

100 series 44-66mm

The DePuy GRIPTION TF Augments and Buttresses

are compatible with the PINNACLE Hip Solutions

Acetabular system. The PINNACLE Hip Solutions

provide the largest selection of advanced bearing

technologies, biological and mechanical

fixation alternatives. With more implant designs

and choices than any competitive system, you’ll

never have to compromise when meeting the

individual needs of patients.

Gription*

Porocoat

Du

oFix*G

rip

tio

n

Gription

Gri

pti

on

Poro

coat

Porocoat Poro

coat

DuoFix

Du

oFix

DuoFix

Marathon

Marathon

Marathon

Marathon

Ultamet

AltrX

AltrX

AltrX

Standard Metal Ultamet

Ultamet

AltrX

BIOLOX deltaaSphere M-Spec

M-Spec

* Gription and DuoFix are currently not indicated for use with the CoMplete™ Acetabular Hip System.

Sector 48-66mm

Multi-Hole 48-72mm

Revision 54-80mm

Deep Profile 54-72mm

Gription*

Porocoat

Du

oFix*G

rip

tio

n

Gription

Gri

pti

on

Poro

coat

Porocoat Poro

coat

DuoFix

Du

oFix

DuoFix

Marathon

Marathon

Marathon

Marathon

Ultamet

AltrX

AltrX

AltrX

Standard Metal Ultamet

Ultamet

AltrX

BIOLOX deltaaSphere M-Spec

M-Spec

* Gription and DuoFix are currently not indicated for use with the CoMplete™ Acetabular Hip System.

Key bone Stock and landmark considerations

Radiographic landmarks can be helpful in

assessing the acetabular bone stock. It can

also be useful to order a CT scan of the

area with a metal suppression technique.

A CT scan will often indicate significantly

more lysis than what is apparent on plain

radiographs, and can also aid in determining

pelvic discontinuities or loss of structural bone.

bone Stock considerationsCompletely supportive acetabulum –

PINNACLE Hip Solutions Shell

Partially supportive acetabulum –

PINNACLE Hip Solutions Shell with

GRIPTION TF Augments

Non-supportive –

PINNACLE Hip Solutions Shell with possible

need for Augment, Buttress or cage

Anatomic landmarks

1. Acetabular teardrop – integrity of medial wall and inferior portion of anterior and posterior column

2. Kohler’s line – integrity of medial wall and superior anterior column

3. Ischial lysis – integrity of posterior wall and posterior column

Type 1

• anterior/posterior columns are intact and supportive

• Greater than 70 percent of host bone to hemispherical shell contact

Type 2a

• anterior/posterior columns are intact and supportive

• Superior migration less than 2cm

• Up to 30 percent of the cup may be uncovered superiorly

Type 2b

• Superior migration less than 2cm

• anterior/posterior columns are supportive

• Greater than 50 percent of host bone to hemispherical shell contact

Type 2c

• Rim is intact but distorted

• Medial wall defect and superior head center migration (<2cm)

• Teardrop is obliterated

Type 3a

• 30-60 percent of rim unsupportive

• Greater than 2cm superior migration

• less than 50 percent of host bone to hemispherical shell contact

Type 3b

• Greater than 60 percent of rim unsupportive

• Significant lysis and loss of posterior column bone stock

• Risk of pelvic discontinuity

Possible Surgical Solutions by Defect classification

The Paprosky Classification is the most

widely used defect classification.5

17

Surgical Technique

Pre-operative Planning and TemplatingUsing the standard DePuy PINNACLE acetabular shell

templates, the surgeon can determine the approximate

size of the revision shell that may be required, including

the possibility of jumbo cups (>66mm diameter), deep

profile cups, or acetabular Augments. Assessing the

acetabular bone stock is of great importance in helping

the surgeon to anticipate the possible structural defects

that may be encountered during the surgery.

18

GRIPTION® TFSurgical

Technique

Once the acetabulum has been exposed and evaluated

preparation for the acetabular construct can begin.

Start by reaming the acetabulum with an undersized

reamer at a level that will restore the appropriate center

of rotation. Ream concentrically with progressively larger

reamers – maintaining appropriate opening abduction

and anteversion. Reaming should stop when adequate rim

contact has been obtained excluding the defect region.

At this point, the surgeon has 3 options for preparing the

acetabular defect to accept the GRIPTION TF Augment:

• Finishing Rasp

• Modular Rasp

• Free hand Technique

acetabular Preparation

Finishing Rasp TechniqueOnce the acetabular cavity has been prepared, place the

hemispherical acetabular trial into the prepared bed at

the correct center of rotation.

Choose the appropriately sized finishing rasp and start

preparing the acetabular defect by keeping the inside

diameter of the finishing rasp against the outer surface

of the acetabular trial.

Advance the rasp slowly until the desired seating level

is obtained. If it appears that there is not intimate bone

contact with the rasp, increasing to the next size of rasp

may be necessary, repeating the steps above until

adequate bone contact has been obtained. Once the

defect has been prepared satisfactorily, tap the

appropriate GRIPTION TF Augment trial into place.

If the trial is stable, then the defect is appropriately

prepared. If adequate bone contact is not obtained,

or the trial is not stable, further preparation with larger

rasps may be needed. If the defect is such that adequate

bone contact and stability cannot be obtained, then

consideration should be given to utilizing a GRIPTION

TF Buttress to span the defect or possibly inverting the

acetabular Augment and using it as a Buttress.

acetabular Preparation

continued

Modular Rasp TechniqueOnce the acetabular cavity has been prepared, utilize the

half shell trial that is undersized by 1mm from the last

reamer or acetabular trial that was used. Place the trial

in the prepared acetabular cavity at the correct center of

rotation. Attach the modular rasp to the dovetail of the

trial and rotate the construct so that the rasp will prepare

the defect appropriately. Starting with the smallest size

rasp, prepare the defect utilizing progressively larger

rasps until the defect has been satisfactorily prepared to

accept the appropriate size Augment. Remove the half

shell trial and insert the appropriate full hemispherical

acetabular trial. The GRIPTION TF Augment trial can now

be placed into the defect and can be tapped into place.

If the trial is stable, the defect is appropriately prepared.

If adequate bone contact is not appreciated or the trial

is not stable, then further preparation with larger rasps

may be needed. If the defect is such that adequate bone

contact and stability cannot be obtained, then

consideration should be given to utilizing a

GRIPTION TF Buttress to span the defect.

21

Once appropriate stability has been obtained for the

Augment trial, the real Augment is ready to be placed.

Free Hand TechniqueOnce the acetabular cavity has been prepared,

a hand held burr can be utilized to prepare and

shape the remaining acetabular defect in order

to accommodate the GRIPTION TF Augment trial.

Care should be taken to remove only the minimum

amount of bone necessary to accommodate the

trial Augment. Frequently test the defect to avoid

unnecessary bone removal using the trial.

22

Implant Insertion

Once the acetabulum and the acetabular defect

have been prepared to accept the acetabular shell

and Augment, the surgeon can decide to place

either the shell first and then the Augment, or

the Augment can be placed initially and the shell

placed secondarily. In addition, at the time of

insertion of the shell and Augment, the surgeon

should decide whether cement fixation or

mechanical fixation will be utilized to join the

Augment to the acetabular shell. It is important

at the time of shell insertion to orient the shell

appropriately so that a screw can be placed

through one of the screw holes in the shell and

also through the fixation slot in the Augment if

mechanically mating.

acetabular Shell-First TechniqueAfter preparation of the acetabulum and

accompanying defect has been completed,

insert the acetabular shell in accordance with

the PINNACLE Acetabular Cup system technique.

Note: Acetabular shells should be

placed at 45 degrees of abduction

and 15 degrees of anteversion.

acetabular Shell-First Technique, continuedScrews for supplemental fixation may be placed at this

point if necessary. The surgeon should pay close attention

to any shift in position of the shell that may occur

secondary to placing and tightening down the screws.

If the shell requires placement of the Augment to provide

stability of the construct, tightening the screws before

placing the Augment may shift the shell slightly. This may

cause difficulty in placing the Augment if the acetabular

defect has been prepared in a precise manner. If a shift

in position of the acetabular shell is noted, the screws

should be backed out slightly to allow the appropriate

placement of the Augment and then re-tighten. If the

shell is stable without initial screw fixation the screws

can be placed after the Augment has been inserted.

Once the acetabular shell is in place, if cement mating

of the two components is desired, a bead of doughy

cement should be placed on the outer surface of the

shell prior to placing the Augment.

The Augment inserter tip should be placed on the

flat surface of the Augment in the two center holes.

The Augment can then be tapped into place behind

the acetabular shell and into the prepared defect.

Tip:

Use the 3.8 drill bit for the

6.5mm cancellous screws.

Use the 3.8 drill bit for the

5.5mm locking screw.

If using 5.0 screw, use the 3.2

drill bit which is utilized

with the PINNACLE

Revision System.

Implant Insertion

continued

acetabular Shell-First Technique, continuedAdditional screw fixation of the Augment can then

be performed. The knurled, threaded pins can be

used to help stabilize the Augment during screw

insertion if necessary.

Alternatively, the surgical assistant can stabilize the

Augment with the inserter tip until provisional screw

fixation is obtained. Tapered head, 5.5mm locking

or 5.0mm non-locking screws should then be placed

utilizing the standard technique.

If mechanical mating of the shell and Augment is

desired, then once the shell and Augment are in

place, a standard PINNACLE 6.5mm screw can be

placed through the shell and the fixation slot of the

Augment. Special care should be taken to ensure

that the head of the screw is fully seated within

the acetabular shell.

Tip:

Use the 3.8 drill bit for the 6.5mm cancellous screws.

Use the 3.8 drill bit for the 5.5mm locking screw.

If using 5.0 screw, use the 3.2 drill bit which is utilized

with the PINNACLE Revision System.

25

augment-First TechniqueAfter the preparation of the acetabulum and

accompanying defect has been completed, the

acetabular Augment can now be placed. Using

the Augment 90-degree inserter tip, place the

inserter into the holes on the inside diameter

of the Augment.

The Augment can now be impacted into the defect

or held in place with the inserter. Insert the knurled,

threaded pins through the holes in the flat face of

the Augment to provide provisional fixation.

Screw fixation utilizing either 5.5mm locking or

5.0 mm non-locking screws can now be performed.

If desired, supplemental fixation utilizing the inside

diameter holes of the Augment can now be

performed as well. Special care should be taken to

ensure that the screw heads are fully seated and

flush or countersunk slightly when utilizing the

inner diameter fixation holes.

Tip:

For pre-drilling the inner diameter screw,

the angled 45-degree drill bit may be easier

to use than a straight drill bit.

26

buttress/ Shim

Surgical Technique

augment-First Technique, continuedIf cement mating of the shell and Augment is

desired, a bead of doughy cement can now be

placed on the inner diameter of the Augment and

the acetabular shell can be impacted in the standard

fashion. Supplemental screw fixation of the shell can

now be undertaken in the standard fashion.

If hybrid mating of the shell and Augment is also

desired, the shell should be carefully positioned

during impaction so that the fixation slot of the

Augment lines up with an appropriate dome hole in

the acetabular shell. The shell should be impacted

utilizing the standard PINNACLE acetabular cup

surgical technique. Once the shell is in position,

supplemental screw fixation of the shell can be car-

ried out in the standard fashion. Additional 6.5mm

screws may be placed through the appropriate dome

hole in the shell and through the fixation slot in the

Augment. Special care should be taken to ensure

that this screw head is fully seated within the inside

diameter of the shell.

Tip:

Bone wax on the tip of the inserter may assist holding

the Augment on the inserter device.

Implant Insertion

continued

In some cases, the acetabular defect will require a

Buttress rather than a simple acetabular Augment in

order to provide appropriate stabilization of the acetabular

construct. Once this has been determined, exposure of

the iliac wing is required. In most cases a large elevator

can be used to subperiosteally elevate the abductor

musculature from the ilium to adequately allow placement

of the Buttress in the correct position. In cases where

exposure is difficult it may be necessary to perform some

type of trochanteric osteotomy or trochanteric slide or a

variant thereof to aid in exposure of the iliac wing in the

supra-acetabular area.

The initial preparation of the acetabulum should be carried

out as noted above in the technique for the standard

Augment. A hemishpherical trial should then be inserted.

Different Buttress trials should then be evaluated to see

which configuration – straight, anterior column or posterior

column best addresses the defect. Since pelvic geometries

differ significantly, shims can be trialed as well to help

position, raise and angulate the Buttress so that it

accommodates both the defect and its apposition to the

acetabular shell optimally. The shim trials snap onto the

Buttress trials to aid in the ease of trialing, especially in

the face of a difficult exposure. The shims can be oriented

in 90 degree increments since the screw holes in the shims

match up with those in the Buttress.

buttress/ Shim

Surgical Technique

Tip:

Select screws that are longer than the

combined thickness of the Buttress and Shim.

buttress/ Shim

Surgical Technique

continued

It should be noted that, since the Buttress does not

have to be in intimate contact with the acetabular

shell being used, a Buttress which is smaller or larger

than the acetabular shell can be utilized if they

appear to provide a more appropriate fit.

buttress InsertionOnce the appropriate position of the Buttress has

been determined, the surgeon has the choice of

which to implant first: the acetabular shell or the

Buttress. If the acetabular shell is placed first, it is

impacted in the standard fashion and supplemental

screw fixation is utilized if necessary. If a shim is to be

utilized on the Buttress, the two components must

be cemented together utilizing bone cement in a

doughy phase with the shim in the same position in

which it was trialed. Care should be taken to remove

any excess cement from the fixation holes in the

shim and Buttress. Once the cement has hardened,

a bead of cement should be placed on the surface

of the acetabular shell which will abut the contact

area of the Buttress. Again, the Buttress does not

have to make intimate contact with the shell if

leaving a small gap results in a better fit.

29

buttress Insertion, continuedThe Buttress construct can then be placed and held in

position with the knurled, threaded guide pins while

screw fixation is being performed or alternatively it can be

held manually. 6.5mm screws are then utilized in the two

holes closest to the acetabular shell and either 5.5mm

locking or 5.0mm non-locking screws can be utilized in

the 4 holes that are more proximal. The distal holes of the

Buttress allow for divergent placement of the screws to

aid in obtaining the best bony fixation possible.

Alternatively, if the Buttress is to be placed first, the

above technique can be utilized as well. Once the

Buttress has been anchored, a bead of cement is placed

on the contact area of the Buttress and the acetabular

shell is then inserted utilizing the standard technique.

Care should be taken when inserting screws into the

Buttress plate to avoid potential neurovascular injury.

30

GRIPTION® TF augmentsCatalog Code Description

1217-10-150 GRIPTION TF Augment size 50/52 x 10
























GRIPTION® TF buttressCatalog Code Description

1217-00-156 GRIPTION TF Buttress 56 Neutral

1217-00-256 GRIPTION TF Buttress 56 Left

1217-00-356 GRIPTION TF Buttress 56 Right







GRIPTION® TF ShimsCatalog Code Description

1217-00-105 GRIPTION TF Shim 5 Degrees



GRIPTION® TF InstrumentsCase One: Trial Case

Catalog Code Description

8299-13-505 5.5mm LOCKING SCREW CADDY


2217-10-150 GRIPTION TF Augment size 50/52 x 10 Trial
























GRIPTION® TF InstrumentsCase One: Trial Case


2217-00-156 GRIPTION TF Buttress 56 Neutral Trial

2217-00-256 GRIPTION TF Buttress 56 Left Trial

2217-00-356 GRIPTION TF Buttress 56 Right Trial







2217-00-105 GRIPTION TF Shim Trial 5 Degrees



2366-83-000 45-Degree Angle Drill

2274-36-000 Duraloc Depth Gauge

2274-09-000 Duraloc Drill Bit 3.8 Dia 10mm

2366-84-000 3.8mm Drill Bit 25mm

2274-12-000 Duraloc Drill Bit 3.8 Dia 40mm

2366-85-000 3.8mm Drill Bit 50mm

2217-01-518 Headed Drill PINNACLE 15mm







9505-02-071 HP Power PINNACLE Driver

2217-01-501 Augment Insert Tip Top

2217-01-502 Augment Insert Tip 90 Degree

2217-01-517 Rasping Power Adaptor

2217-01-516 Rasping Strike Plate

2217-01-503 Augment Rasping Handle

2217-01-500 Augment Adjustable Handles

33

GRIPTION® TF InstrumentsCase Two: Finishing Rasp Case


2217-10-550 PINN AUGMENT FIN RASP 50X10


















2217-30-550 PINN AGUMENT FIN RASP 50X30






Case Three: Modular Rasp Case


2217-01-550 PINN AUGMENT MOD RASP 50/52






34

GRIPTION® TF InstrumentsCase Three: Modular Rasp Case


2217-01-649 HALF SHELL TRIAL 49mm






2217-01-580 PINN AUGMENT RASP +5mm OFFSET



Buttress Screw Options: 6.5mm Cancellous Screws


121715500 PINN CAN BONE SCREW 6.5mmX15mm












Buttress Screw Options: 5.5mm PolyAxial Locking Screws


815355014 5.5mm POLYAXIAL SCREW FT 14mm








GRIPTION® TF InstrumentsAugment Screw Options: 5.5mm PolyAxial Locking Screws












Augment Screw Options: 5.5mm PolyAxial Non-Locking Screws


815455040 5.5mm NONLOCK SCREW PT 40mm







Augment Screw Options: 5.0mm Cancellous Screws


125725000 5.0mm DIA TPRD HD PER SCRW 25










36

DePuy GRIPTION® TF acetabular augment System IMPORTANTThis Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

INDICATIONS The DePuy GRIPTION TF Acetabular Augments, Buttresses and Shims are indicated for use with the PINNACLE Acetabular Cup System, the PINNACLE Bantam Acetabular Cup System and the PINNACLE Revision Acetabular Cup System for total hip replacement in the following conditions:

severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery; and certain cases of ankylosis.

INTENDED USEThe porous GRIPTION TF titanium acetabular Augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled Augment/acetabular cup construct is intended for cemented or cementless use.

The porous GRIPTION TF titanium shim is affixed to the mating Buttress using bone cement. This porous GRIPTION TF titanium Buttress is affixed to the mating acetabular cup using bone cement. The assembled Buttress/acetabular cup construct is intended for cemented or cementless use.

CONTRAINDICATIONSAbsolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and/or 7) vascular insufficiency, muscular atrophy, or neuromuscular disease.

WARNINGS AND PRECAUTIONSCeramic-coated femoral stem prostheses are indicated for uncemented press fit fixation.

CAUTION: DO NOT USE BONE CEMENT FOR FIXATION OF A CERAMIC COATED PROSTHESIS.

Components labeled for “Cemented Use Only” are to be implanted only with bone cement. The following conditions tend to adversely affect hip replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, history of infections, severe deformities leading to impaired fixation or improper positioning, tumors of the supporting bone structures, allergic reactions to materials, tissue reactions, and disabilities of other joints.

ADVERSE EVENTS The following are the most frequent adverse events after hip arthroplasty, change in position of the components, loosening of components, wear or fracture of components, dislocation, infection, peripheral neuropathies, tissue reaction.

REFERENCES1. DePuy Orthopaedics, Inc. Data on file.

2. Zhang Y, Ahn PB, Fitzpatrick DC, Heiner AD, Poggie RA, Brown TD. “Interfacial frictional behavior: cancellous bone, cortical bone, and a novel porous tantalum biomaterial.” J Musculoskel Res. 1999;3(4):245-251.

3. Krygier JJ, Bobyn JD, Poggie RA, et al. “Mechanical characterization of a new porous tantalum biomaterial for orthopaedic reconstruction.” Proc SIROT (International Research Society of Orthopaedic Surgery and Traumatology). Sydney Australia, 1999.

4. http://www.zimmer.com/z/ctl/op/global/action/1/id/9193/template/MP/prcat/M6/prod/y

5. Paprosky, W.G., P.G. Perona and M.J. Lawrence. “Acetabular Defect Classification and Surgical Reconstruction in Revision Arthroplasty: A 6-Year Follow-Up Evaluation.” The Journal of arthroplasty 9(1),1994:33-44.

DePuy Orthopaedics, Inc.700 Orthopaedic Drive Warsaw, IN 46581-0988USATel: +1 (800) 366 8143Fax: +1 (574) 267 7196

www.depuy.com

©DePuy Orthopaedics, Inc. 2011. All rights reserved.

0612-04-511

design rationale/surgical technique gription tf...1.02 1.00 0.98 0.96 0.94 0.92 0.90 0.88 0.86 0.84...

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