EP-FIT PLUS® - CMM SL

EP-FIT PLUS® - CMM SL EP-FIT PLUS® - CMM SL

Know-how brings motion back to life. SM<br />

<strong>EP</strong>-<strong>FIT</strong> PLUS ®<br />

Non-cemented<br />

press-fit Acetabular Cup System<br />

Surgical Technique


Table of Contents<br />

1 Foreword 3<br />

2 Indications 4<br />

3 Contraindications 4<br />

4 Case Study 5<br />

5 Preoperative Planning 5<br />

6 Surgical Technique 6<br />

7 Postoperative Treatment 18<br />

8 Sterilisation 18<br />

9 References 19<br />

10 Implants 20<br />

11 Instrumentation 26


1. Foreword<br />

Shells conceived on the basis of the press-fit principle<br />

offer a number of advantages for total hip<br />

replacement, including ease of manipulation and a<br />

minimum degree of bone resection. In an acetabulum<br />

that is not deformed, the implantation of a<br />

hemispherical press-fit shell without oversizing<br />

results in a large percentage of the mechanical load<br />

being borne by the central region of the acetabulum.<br />

Moreover, the peripheral ring – especially its lower<br />

section – will in part remain free of loading. For this<br />

reason hemispherical shells often have a limited<br />

stability. Additional measures to improve stability, for<br />

instance the use of screws or mandrels and/or the<br />

use of shells with oversizing (Lachiewicz et al., 1989),<br />

can introduce other problems.<br />

In contrast, a hemispherical press-fit shell will bring<br />

greater stability in a patient with protrusio acetabuli.<br />

Here, the mechanical loading is primarily on the<br />

peripheral zone (Adler et al., 1992). It is therefore a<br />

logical step to optimise the intrinsic stability of the<br />

press-fit shell by reproducing the protrusio situation.<br />

We have therefore developed a shell that is not<br />

spherical throughout, with a patented Triple Radius<br />

Profile and which has proven itself over years of use<br />

of the <strong>EP</strong>F ® -PLUS‚ and PLUS-<strong>FIT</strong> TM acetabular cups.<br />

<strong>EP</strong>-<strong>FIT</strong> PLUS ® is the latest generation of both these<br />

cup systems with direct anchorage for hard articulating<br />

surfaces and with a greater surface roughness.<br />

After implantation of the shell, the Triple Radius<br />

Profile results in a gap of approximately 2 mm<br />

between the roof of the shell and the hemispherical<br />

reamed acetabulum. The actual dimensions of the<br />

gap will vary, however, depending on the quality<br />

and elasticity of the bone. This results in a close contact<br />

in the peripheral zone of the shell and a relatively<br />

low contact in the pole region, yielding a favorable<br />

prestressing of the wall of the acetabulum.<br />

These stress gradients, declining from the rim towards<br />

the dome of the acetabulum, result in a large percentage<br />

of the mechanical loading being transferred<br />

to the wall of the acetabulum. This is in contrast to<br />

oversized hemispherical cups, where only a narrow<br />

area along the acetabular rim is subject to loading,<br />

and so may result in overloading of the bone in this<br />

area.<br />

In summary, the <strong>EP</strong>-<strong>FIT</strong> PLUS ® system has the advantage<br />

of reducing the risk of fracture of the acetabulum<br />

during implantation, whilst maintaining excellent<br />

primary stability through connection to bone<br />

over a large area along the wall of the acetabulum.<br />

3


2. Indications<br />

All forms of osteoarthritis.<br />

Progressive loss of function of the hip joint as a result of a degenerative post-traumatic or<br />

inflammatory/rheumatic destruction of the joint.<br />

Femoral head necrosis.<br />

Proximal femoral fractures (especially femoral neck).<br />

Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies,<br />

arthrodesis or failed joint replacement.<br />

3. Contraindications<br />

Acute or chronic infections, local or systemic.<br />

Severe damage to muscles, nerves or vessels that are a risk to the affected extremity.<br />

Severe bone defects or poor bone quality, endangering the stability of the implant.<br />

Associated disorders that could interfere with the functioning of the implant.<br />

Remark<br />

Using hard-hard pairings, it is imperative to follow the specifications in the particular chapters.<br />

The above-mentioned indications and contraindications apply for both primary interventions<br />

and revisions.<br />

If a revision is performed then preferably an oversized implant should be chosen. Multihole<br />

cups can be used for difficult cases.<br />

4


4. Case Study<br />

Preoperative<br />

Postoperative<br />

Female patient with dysplastic hip with OA.<br />

<strong>EP</strong>-<strong>FIT</strong> PLUS ® shell with <strong>SL</strong>-PLUS ® stem in a female<br />

patient with dysplastic hip with OA.<br />

Restoration of leg length.<br />

5. Preoperative Planning<br />

The surgeon uses the radiographic template (15% enlarged) to plan<br />

The intended size of the implant.<br />

The ideal position of the shell in relation to the acetabular teardrop figure.<br />

Note<br />

Exact determination of the size of a shell preoperatively using radiographic templates is only<br />

possible to a certain degree.<br />

In general, the removed femoral head gives a good indication of the size of the acetabular cup.<br />

With a normal acetabulum, the definitive size of the shell is 4 – 6 mm larger than the anteroposterior<br />

diameter of the removed femoral head.<br />

The correct shell size is finally judged on the basis of the definitive reamer size/the correct<br />

trial shell.<br />

5


6. Surgical Technique<br />

Note<br />

Users of minimally invasive surgical techniques, please work through the following surgical<br />

instructions additionally: postero-lateral approach (Lit. No. 1426); antero-lateral approach<br />

(Lit. No. 1483); anterior approach (Lit. No. 1494).<br />

1. Position of patient and approach<br />

Surgery is performed with the patient in an extended<br />

supine or lateral position.<br />

Surgical approach – lateral or dorsolateral – is determined<br />

on the basis of the patient data established in<br />

advance and preference of the surgeon.<br />

2. Removal of the femoral head<br />

An osteotomy of the femoral neck is performed in<br />

accordance with the preoperative planning for the<br />

corresponding stem system.<br />

3. Preparation of the acetabulum<br />

The joint capsule is opened and sufficiently resected,<br />

fully if necessary.<br />

The acetabulum is exposed to allow a good view and<br />

sufficient room for reaming instruments.<br />

6


4. Assembly of the reamer<br />

The reamer is placed on the drive shaft using pressure<br />

and turned clockwise until the locking mechanism<br />

snaps in.<br />

5. Reaming of the acetabulum<br />

The acetabulum is reamed using a spherical original<br />

Plus Orthopedics reamer with increasing diameter<br />

until the cartilage layer is fully removed and the subchondral<br />

bone bleeds uniformly.<br />

Note<br />

It is recommended to begin with a reamer size equal to or 2 mm smaller than the head size<br />

and that reaming is continued down to the base of the fovea acetabuli (teardrop figure).<br />

As much hard sclerotic bone as possible should be removed from the pole region, but retained<br />

in the peripheral zone. It may be advisable to choose a reamer that is in relation to the cup<br />

size 1 mm larger to avoid fissures and ensure optimal seating.<br />

Excessive reaming of the periphery should at all times be avoided as this would result in a<br />

level of bone loss, especially at the anterior and posterior columns of the acetabulum, that is<br />

too high.<br />

The bone slurry that remains in the last reamer can be used to fill in the gap between the<br />

acetabulum and the implant later on.<br />

Reamers with 1 mm increments are available (see page 37).<br />

7


6. Determination of the implant size using the<br />

trial shell<br />

Screw the trial shell onto the shell inserter (130707).<br />

An alignment guide (130728) may be used for orientation<br />

purposes relative to the cup position. The<br />

assembled alignment guide is mounted on the shell<br />

inserter with the trial shell.<br />

The aim is an anteversion of 10° and an inclination<br />

of 45°. Align the shell inserter in such a way that rod<br />

(1) is perpendicular to the coronal plane and rod (2)<br />

is perpendicular to the sagittal plane of the patient.<br />

If the patient is lying in the supine position (see illustration,<br />

here: using the example of a right hip) the<br />

long edge of the table can serve as an orientation<br />

guide.<br />

The trial shell is placed in the reamed acetabulum by<br />

exerting pressure on the shell inserter (but without<br />

using an impacting tool).<br />

Verification of correct seating in the acetabulum. After removal of the shell inserter the cup<br />

position and depth can be checked. The trial shell is then removed with the shell inserter<br />

screwed back in.<br />

Note<br />

In contrast to the original implants the trial shells are not oversized. If the desired degree of<br />

stability is not attained then the depth of the bone bed has to be increased (see No. 5. Reaming<br />

of the acetabulum) or the next largest size of trial shell chosen.<br />

8


7. Implantation of the titanium shell with trial shell inserter<br />

Bone slurry from the last reaming procedure can be<br />

uniformly distributed in the acetabulum to compensate<br />

for possible gaps.<br />

Mount the shell, of predetermined size, on the shell<br />

inserter (130707).<br />

If necessary, mount the alignment guide (130728)<br />

on the shell inserter.<br />

Position the cup shell in the acetabulum and align<br />

the shell inserter as described in No. 6.<br />

The inclination should ideally be 40 – 50º and anteversion<br />

10 – 20º to achieve optimum results. Final<br />

acetabular component orientation must also consider<br />

the position of the femoral implant, the stability and<br />

degree of bone coverage as well as correct soft tissue<br />

tensioning, to achieve the optimal result for each<br />

patient. Any inclination of the shell greater than 50º<br />

must be avoided because of possible impingement<br />

and/or a tendency towards dislocation. It may be<br />

advantageous to use a reliable navigation system to<br />

position the cup as this would considerably improve<br />

the accuracy of positioning.<br />

If no screws are used the cup should be oriented<br />

with screw holes inferiorly. The implant is inserted<br />

into the acetabulum by impaction with the shell<br />

inserter and the impaction/extraction hammer<br />

(130705).<br />

Note<br />

The information on the use of ceramic, metal and<br />

PE inserts must be followed without fail (see nos. 13<br />

to 15).<br />

9


8. Implantation of the titanium shell using the<br />

shell inserter (US version)<br />

The shell inserter (130987) can be used instead of<br />

the trial shell inserter.<br />

9. Verification of position in the acetabulum<br />

The distance (1 –2 mm) between the implant and<br />

the acetabulum is measured using the depth gauge<br />

for shell (130731) through the apex hole.<br />

Note<br />

Additional fixation of the <strong>EP</strong>-<strong>FIT</strong> PLUS ® press-fit shell<br />

by screws is not routinely necessary, but may be<br />

required routinely in certain circumstances.<br />

10. Fixation of the shell with screws<br />

The procedure is the same as for No. 7 above, but<br />

the screw-holes should be aligned in a superolateral<br />

position upon insertion of the shell.<br />

Drill the intended holes using the drill guide<br />

(130847) and flexible drill shaft (130490).<br />

Insert the screws into the pelvis with the screwdriver<br />

(130710). An anterior or central position of<br />

the screws must at all times be avoided as this could<br />

result in damage to the large pelvic vessels and<br />

nerves.<br />

Note<br />

Only Plus Orthopedics cancellous bone screws<br />

(25281 – 25286) with a low head profile are to be<br />

used.<br />

10


11. Optionally: trial reduction using trial insert<br />

(standard 130826 – 130837/ hooded 130850 – 130857)<br />

The trial stem is inserted in the femur after the femur<br />

has been prepared (see corresponding surgical procedure).<br />

Disassemble the inserter (130818).<br />

Inner section<br />

Outer section<br />

Screw the corresponding size of trial insert (standard<br />

and hooded) into the inner section of the seating<br />

instrument.<br />

Insert the trial insert into the implanted shell.<br />

Unscrew the inner part of the inserter. Check the<br />

seating of the insert in the shell, reduce and manipulate.<br />

Check the correct positioning of the PE insert within<br />

the shell.<br />

Screw the internal part of the seating instrument<br />

back into the trial insert, then loosen and remove it<br />

through a gentle tilting action.<br />

12. Thoroughly rinse the implanted shell and carefully remove the bone debris.<br />

11


13.a Placement of the standard polyethylene<br />

insert using the inserter/impactor<br />

To position the polyethylene insert, it is recommended<br />

to use the inserter/impactor (130818).<br />

The inserter/impactor must be reassembled to do so.<br />

Screw the adapter for the PE insert and the impactor<br />

head onto the inserter/impactor. Retract the internal<br />

section of the inserter/impactor and mount the PE<br />

insert on the three nipples.<br />

Insert the PE in the shell by impacting the inner section<br />

of the inserter/impactor.<br />

Optionally<br />

Check the fit of the PE insert in the shell using a raspatory.<br />

Note<br />

The PE insert must not be re-used.<br />

Rim osteophytes must be carefully removed to prevent<br />

anterior or lateral impingement, tendencies to<br />

dislocation or restriction of movement.<br />

12


13.b Insertion of the hooded polyethylene insert using the inserter/impactor<br />

It is recommended to insert the hooded polyethylene insert using the inserter/impactor (130818).<br />

The procedure for the hooded polyethylene insert and the inserting device is analogous to the<br />

description under 13.a.<br />

Note<br />

The position of the shoulder of the hooded PE inserts can be changed in 30º increments.<br />

14. Use of the BIOLOX ® forte ceramic insert<br />

Indications and contraindications<br />

The same indications and contraindications apply to the use of the BIOLOX ® forte cup inserts<br />

as for total hip arthroplasty with other articulating surfaces.<br />

The following additional contraindications apply to ceramic inserts:<br />

The inclination should not be substantially above or below the range 40 – 50º.<br />

The anteversion must not be above or below the range 10 – 20º.<br />

If the angle of inclination is below 30º or above 50º BIOLOX ® forte insert must not be used.<br />

Plus Orthopedics standard and hooded PE inserts are available for such cases.<br />

Ceramic cup inserts should similarly not be used for cups in a retroversion mode.<br />

Risk of impingement should at all times be avoided.<br />

Implantation<br />

A trial insert should be used before a ceramic insert is implanted. Trial heads of the intended<br />

diameter must then be used to ensure an adequate range of motion (ROM) in all directions and<br />

to check the stability of the joint. The artificial joint must not dislocate in the course of movement<br />

or subluxate through impingement of the implant components or soft tissue.<br />

The alignment guide (130728) should always be used with BIOLOX ® forte ceramic inserts in<br />

order to obtain the necessary level of accuracy.<br />

It is advisable to use computer-assisted navigation systems intra-operatively for documentation<br />

and verification of the implant position and to get exact information on the ROM.<br />

13


Placement of the ceramic insert<br />

The procedure for the trial insert is the same as<br />

described under No. 11.<br />

Before insertion it must be ensured that the inner<br />

surface of the metal shell is dry and free of any<br />

debris.<br />

Remove the BIOLOX ® forte ceramic insert with the<br />

premounted CeraLock ® insertion aid from its packaging.<br />

Remove the transparent Plexiglas triggering<br />

protection and dispose of it.<br />

Place the CeraLock ® insertion aid on the front face of<br />

the metal shell so that all 3 arms lie on the edge and<br />

the BIOLOX ® forte ceramic insert cannot tilt.<br />

Exert force on the CeraLock ® plateau and press the<br />

BIOLOX ® forte ceramic insert home into the shell.<br />

The instrument will have now released the<br />

BIOLOX ® forte insert. Remove the CeraLock ® insertion<br />

aid and dispose of it. It is intended for single<br />

usage only and must not be resterilised.<br />

The correct position of the insert in the metal shell<br />

must be checked. Using the tip of the fingers, touch<br />

the 2 front faces of the insert and metal shell. If the<br />

position of the insert over its entire circumference is<br />

level to the metal edge then it is correctly positioned<br />

in the shell.<br />

14


Note<br />

To ensure that the BIOLOX ® forte ceramic insert is inserted correctly, it is supplied with a premounted<br />

CeraLock ® insertion aid.<br />

If the patients anatomy does not allow or limit the use of the CeraLock ® to a certain degree,<br />

the ceramic insert can be carefully placed in the cup by hand and pressed home.<br />

Prevention of fracture of a ceramic component<br />

If a ceramic component damage is discovered intraoperatively or a damage is suspected for<br />

good reasons, a ceramic insert must not be used. If already implanted, it must be removed.<br />

A new ceramic inlay must only be used if the internal cone of the shell is free of damage.<br />

Revision involving a broken ceramic insert<br />

In case of acetabular cup revision in which a broken conically fixed ceramic insert is removed a<br />

ceramic insert must not be used again. The cone of the cup may have been damaged during<br />

the reoperation and would then no longer satisfy the requirements placed on plug connections<br />

for conically fixed ceramic inserts. The risk of a fracture is above average.<br />

A polyethylene insert should be used as an alternative.<br />

Revision of a broken ceramic femoral head<br />

On a femoral prosthesis left in situ after revision of a ceramic femoral head, Plus Orthopedics<br />

recommends the use of a BIOLOX ® OPTION (Material: BIOLOX ® delta) femoral head with metal<br />

sleeve (Material: TiAl6V4) to be inserted. The BIOLOX ® OPTION system can be used with any<br />

acetabular insert of the BIOLOX ® family as well as with Plus Orthopedics Polyethylen/Rexpol ®<br />

inserts.<br />

If both components (ball head and insert) are made of ceramic, in case of revision following a<br />

fracture of one of the two components both the insert and the ball head have to be replaced.<br />

15


15. Use of the PLUSMET ® metal insert<br />

Indications and contraindications<br />

Basically the same indications, contraindications and recommendations applying for THR with<br />

other articulating surfaces, also apply for PLUSMET ® metal inserts.<br />

The following additional contraindications have to be considered for metal inserts:<br />

Patients with chronic renal failure, renal insufficiency or on dialysis.<br />

Patients with known allergies of any kind or occupational exposure to Cobalt, Chrome or<br />

Molybdenum.<br />

If angle of inclination is below 30º or above 50º, the PLUSMET ® metal insert must not be used.<br />

If angle of anteversion underruns 10º or exeeds 20º the PLUSMET ® metal insert must not<br />

be used. Plus Orthopedics standard and hooded PE inserts are available for such cases.<br />

If a stable reduction cannot be achieved.<br />

If cup is positioned in a retroversion mode.<br />

Risk of impingement should at all times be avoided.<br />

Implantation<br />

A trial insert should be used before a metal insert is implanted. Trial heads of the intended<br />

diameter must then be used to ensure an adequate range of motion (ROM) in all directions of<br />

movement and to check the stability of the joint. The artificial joint must not dislocate in the<br />

course of movement or subluxate through impingement of the implant components or soft tissue.<br />

Pressure of the neck of the prosthesis at the edge of the metal insert may cause point loads<br />

that increase the risk of abrasion.<br />

The alignment guide (130728) should always be used with PLUSMET ® metal inserts in order to<br />

obtain the necessary level of accuracy.<br />

It is advisable to use computer-assisted navigation systems intraoperatively for documentation<br />

and verification of the implant position, and to get exact information on the ROM.<br />

16


Placement of the metal insert (ME)<br />

Proceed with the trial insert as described in section 11.<br />

Before insertion it must be ensured that the internal<br />

surface of the metal shell is dry and free of any contamination.<br />

Screw the adapter for ME-inserts (130989 – 130993)<br />

and the impactor head onto the inserter/impactor.<br />

Attach the implant onto the adapter.<br />

Place the 3 arms of the adapter on the front face of<br />

the metal shell so that the PLUSMET ® metal insert is<br />

not tilting.<br />

Insert it into the shell by gently hitting the inserter/<br />

impactor.<br />

Note<br />

To impact the metal/insert only the above described<br />

adapter respectively inserter/impactor must be used.<br />

17


16. Revision of the metal/ceramic insert<br />

Screw the extraction instrument for metal/ceramic<br />

inserts onto the inserter/impactor (130818).<br />

Position the extraction instrument on the edge of<br />

the metal/ceramic insert with care. Fit the 3 tips into<br />

the lateral recess in the shell – they are correctly<br />

positioned when lateral torsion is not possible.<br />

Release the metal/ceramic insert by impaction of the<br />

inserter/impactor and remove it.<br />

7. Postoperative Treatment<br />

The treatment of the patient after surgery will depend on several factors (in particular the surgical<br />

approach, the stem prosthesis used and any attendant diseases). If the patient has a good<br />

bone quality and the primary implantation of both prosthesic components is stable, then it is<br />

recommended that the patient use walking aids for 6 – 12 weeks after surgery.<br />

However, the exact degree of walking assistance required will have to be decided by the physician<br />

for each individual patient.<br />

8. Sterilisation<br />

Implants<br />

All the implants described in this Operating Technique are sterile when they are delivered by<br />

the manufacturer. Re-sterilisation is not allowed.<br />

Instruments<br />

System components and instruments are not sterile when they are delivered. Before use they<br />

must be cleaned by the usual methods in accordance with internal hospital regulations and<br />

sterilised in an autoclave in accordance with the legal regulations and guidelines applicable in<br />

the relevant country. (For detailed information please refer to leaflet Lit. No. 1363.)<br />

The correct settings are given in the instructions for use issued by the autoclave manufacturer.<br />

Instrument manufacturers and dealers accept no responsibility for sterilisation of products by<br />

the customer.<br />

18


9. References<br />

Zwartelé RE, Brand R, Doets HC<br />

Increased risk of dislocation after primary total hip arthroplasty in inflammatory arthritis –<br />

prospective observational study of 410 hips<br />

Acta Orthop Scand, 2004; 12<br />

Adler E, Stuchin A, Kummer FJ<br />

Stability of Press-Fit acetabular cup.<br />

J Arthroplasty 1992; 7:295-301<br />

Doets HC, Olsthoorn PGM, Schmotzer H<br />

Medium-term results with the Enhanced Press-Fit Cup in osteoarthrosis, rheumatoid arthritis<br />

and revision arthroplasty, 2003.<br />

Engh CA, Griffin WL, Marx CL<br />

Cementless acetabular components.<br />

J Bone Joint Surg (Br) 1990; 72B:53-59<br />

Lachiewicz PF, Suh PB, Gilbert JA<br />

In vitro initial fixation of porous-coated acetabular total hip components. A biomechanical<br />

comparative study.<br />

J Arthroplasty 1989; 4:201-205<br />

Lintner F, Zweymüller K, Brand G<br />

Tissue reactions to titanium endoprostheses.<br />

J Arthroplasty 1986; Vol. 1, No. 3:183-95<br />

McKenzie JR, Callaghan JJ, Pedersen P, Brown TD<br />

Areas of contact and extent of gaps with implantation of oversized acetabular components<br />

in Total Hip Arthroplasty.<br />

Clin Orthop 1984; 208:127-136<br />

Snorrason F, Kärrholm PJ<br />

Migration of fully threaded acetabular components.<br />

A roentgen stereo-photogrammetic analysis.<br />

J Bone Joint Surg 1990; 72B:647-652<br />

19


10. Implants<br />

Shells<br />

Shell Ti-plasma,<br />

without screwholes<br />

Shell Ti-plasma with hydroxyapatite<br />

coating, without screwholes<br />

Art. No.<br />

Size<br />

Art. No.<br />

Size<br />

15300 40<br />

15301 42<br />

15302 44<br />

15303 46<br />

15304 48<br />

15305 50<br />

15306 52<br />

15307 54<br />

15308 56<br />

15309 58<br />

15310 60<br />

15311 62<br />

15340 40<br />

15341 42<br />

15342 44<br />

15343 46<br />

15344 48<br />

15345 50<br />

15346 52<br />

15347 54<br />

15348 56<br />

15349 58<br />

15350 60<br />

15351 62<br />

Shell Ti-plasma,<br />

with screwholes<br />

Art. No. Size No. of<br />

holes<br />

15320 40 2<br />

15321 42 2<br />

15322 44 2<br />

15323 46 2<br />

15324 48 2<br />

15325 50 2<br />

15326 52 2<br />

15327 54 2<br />

15328 56 3<br />

15329 58 3<br />

15330 60 3<br />

15331 62 3<br />

15332 64 3<br />

15333 66 3<br />

15334 68 3<br />

Shell Ti-plasma with hydroxyapatite<br />

coating, with screwholes<br />

Art. No. Size No. of<br />

holes<br />

15360 40 2<br />

15361 42 2<br />

15362 44 2<br />

15363 46 2<br />

15364 48 2<br />

15365 50 2<br />

15366 52 2<br />

15367 54 2<br />

15368 56 3<br />

15369 58 3<br />

15370 60 3<br />

15371 62 3<br />

15372 64 3<br />

15373 66 3<br />

15374 68 3<br />

20


Shell Ti-plasma, multi-hole<br />

Art. No. Size No. of<br />

holes<br />

15410 56 6<br />

15411 58 6<br />

15412 60 6<br />

15413 62 6<br />

15414 64 6<br />

15415 66 6<br />

15416 68 6<br />

21


Inserts<br />

Note<br />

All cup inserts must only be used in combination with the acetabular cup systems approved<br />

by Plus Orthopedics.<br />

PE inserts, standard<br />

Art. No. Ø Size<br />

15462 22 mm 40 – 44<br />

15463 22 mm 46<br />

15464 22 mm 48<br />

15465 22 mm 50<br />

15470 28 mm 46<br />

15471 28 mm 48<br />

15472 28 mm 50 – 52<br />

15473 28 mm 54 – 56<br />

15474 28 mm 58 – 68<br />

15481 32 mm 50 – 52<br />

15482 32 mm 54 – 56<br />

15483 32 mm 58 – 68<br />

PE inserts, hooded, 15°<br />

Art. No. Ø Size<br />

15486 28 mm 46<br />

15487 28 mm 48<br />

15488 28 mm 50 – 52<br />

15489 28 mm 54 – 56<br />

15490 28 mm 58 – 68<br />

15491 32 mm 50 – 52<br />

15492 32 mm 54 – 56<br />

15493 32 mm 58 – 68<br />

REXPOL TM , standard<br />

Art. No. Ø Size<br />

15570 28 mm 46<br />

15571 28 mm 48<br />

15572 28 mm 50 – 52<br />

15573 28 mm 54 – 56<br />

15574 28 mm 58 – 68<br />

15582 32 mm 50 – 52<br />

15583 32 mm 54 – 56<br />

15584 32 mm 58 – 68<br />

REXPOL TM , hooded 15°<br />

Art. No. Ø Size<br />

15500 28 mm 46<br />

15501 28 mm 48<br />

15502 28 mm 50 – 52<br />

15503 28 mm 54 – 56<br />

15504 28 mm 58 – 68<br />

15512 32 mm 50 – 52<br />

15513 32 mm 54 – 56<br />

15514 32 mm 58 – 68<br />

Note<br />

Only a combination of BIOLOX ® forte/delta ball heads with cup inserts of BIOLOX ® forte/delta<br />

is permitted. Any of the BIOLOX ® forte/delta family of ball heads may be used with any of the<br />

ceramic inserts from the BIOLOX ® family, provided that the correct head/calotte diameter is<br />

used.<br />

Other components that have not been approved by Plus Orthopedics must not be used.<br />

Pairings with 32 mm ball heads or bogger generally improve the range of motion and thus<br />

reduce the risk of impingement and subluxation.<br />

22


Metal inserts, standard<br />

Art. No. Ø Size<br />

15100 28 mm 46<br />

15101 28 mm 48<br />

15102 28 mm 50 – 52<br />

15103 28 mm 54 – 56<br />

15104 28 mm 58 – 68<br />

Ceramic inserts, standard<br />

Art. No. Ø Size<br />

15140 28 mm 46<br />

15141 28 mm 48<br />

15142 28 mm 50 – 52<br />

15143 28 mm 54 – 56<br />

15144 28 mm 58 – 68<br />

15149 32 mm 46<br />

15150 32 mm 48<br />

15151 32 mm 50 – 52<br />

15152 32 mm 54 – 56<br />

15153 32 mm 58 – 68<br />

66021 44/36 mm 50 – 52<br />

66022 48/36 mm 54 – 56<br />

66023 52/36 mm 58 – 68<br />

Note<br />

<strong>EP</strong>-<strong>FIT</strong> PLUS ® metal inserts must only be used with PLUSMET ® metal ball heads for metal/metal<br />

pairings. Ball heads from other manufacturers must not be used.<br />

23


Ball heads<br />

Ceramic ball heads, BIOLOX ® forte<br />

Art. No. Ø Cone Neck length<br />

16151 28 mm 12/14 S<br />

16152 28 mm 12/14 M<br />

16153 28 mm 12/14 L<br />

16161 32 mm 12/14 S<br />

16162 32 mm 12/14 M<br />

16163 32 mm 12/14 L<br />

66011 36 mm 12/14 S<br />

66012 36 mm 12/14 M<br />

66013 36 mm 12/14 L<br />

66014 36 mm 12/14 XL<br />

Metal ball heads, PLUSMET ®<br />

Art. No. Ø Cone Neck length<br />

16181 28 mm 12/14 S<br />

16182 28 mm 12/14 M<br />

16183 28 mm 12/14 L<br />

16184 28 mm 12/14 XL<br />

16185 28 mm 12/14 XXL<br />

16186 28 mm 14/16 S<br />

16187 28 mm 14/16 M<br />

16188 28 mm 14/16 L<br />

16189 28 mm 14/16 XL<br />

16190 28 mm 14/16 XXL<br />

24


Ceramic ball heads, BIOLOX ® OPTION (for revisions)<br />

Art. No. Ø Cone Neck length<br />

CE3849717693581 28 mm 12/14 S<br />

CE3849717693582 28 mm 12/14 M<br />

CE3849717693583 28 mm 12/14 L<br />

CE3849717693584 28 mm 12/14 XL<br />

CE3849717694581 32 mm 12/14 S<br />

CE3849717694582 32 mm 12/14 M<br />

CE3849717694583 32 mm 12/14 L<br />

CE3849717694584 32 mm 12/14 XL<br />

Note<br />

Before the BIOLOX ® forte/delta/OPTION, PLUSMET ® ball head is placed on the stem it must be<br />

ensured that the cone is free of contaminating particles such as bone fragments, metal or<br />

cement, and that it is not damaged.<br />

Cancellous bone screws<br />

Art. No. Description Ø Length<br />

25281 Cancellous bone screw 6,5 mm 20 mm<br />

25282 Cancellous bone screw 6,5 mm 25 mm<br />

25283 Cancellous bone screw 6,5 mm 30 mm<br />

25287 Cancellous bone screw 6,5 mm 35 mm<br />

25284 Cancellous bone screw 6,5 mm 40 mm<br />

25288 Cancellous bone screw 6,5 mm 45 mm<br />

25285 Cancellous bone screw 6,5 mm 50 mm<br />

25289 Cancellous bone screw 6,5 mm 55 mm<br />

25286 Cancellous bone screw 6,5 mm 60 mm<br />

<strong>EP</strong>-<strong>FIT</strong> PLUS ® , PLUSMET ® , PLUS-<strong>FIT</strong> TM and <strong>SL</strong>-PLUS ® are trademarks of Plus Orthopedics AG, Switzerland, registered in Switzerland<br />

and other selected countries.<br />

CeraLock ® , BIOLOX ® forte, BIOLOX ® OPTION and BIOLOX ® delta are registered trademarks of CeramTec AG, Germany.<br />

25


11. Instrumentation<br />

Case 1<br />

1 A Basic Case: Instruments and trial shells<br />

Art. No. Description Size<br />

130994 Basic Case I (without cover)<br />

130999 Cover for <strong>EP</strong>-<strong>FIT</strong> PLUS ® case<br />

130707 Shell Inserter, standard version<br />

130705 Insertion/Extraction hammer<br />

130728 Shell alignment guide, standard version<br />

130731 Depth gauge for shell<br />

130734 Trial shell 40<br />

130735 Trial shell 42<br />

130712 Trial shell 44<br />

130713 Trial shell 46<br />

130714 Trial shell 48<br />

130715 Trial shell 50<br />

130716 Trial shell 52<br />

130717 Trial shell 54<br />

130719 Trial shell 56<br />

130720 Trial shell 58<br />

130721 Trial shell 60<br />

130723 Trial shell 62<br />

130724 Trial shell 64<br />

130736 Trial shell 66<br />

130737 Trial shell 68<br />

130820 Extraction instrument for metal/ceramic insert to 130818 46<br />

130794 Extraction instrument for metal/ceramic insert to 130818 48<br />

130795 Extraction instrument for metal/ceramic insert to 130818 50 – 52<br />

130796 Extraction instrument for metal/ceramic insert to 130818 54 – 56<br />

130797 Extraction instrument for metal/ceramic insert to 130818 58 – 68<br />

26


3<br />

3<br />

5<br />

4 2<br />

6 1<br />

27


1 B Tray: Reamer (2 mm increments) and inserter/impactor for PE inserts<br />

Art. No. Description Size<br />

130996 Tray to Case 130994<br />

130870 Drive shaft, with Synthes-coupling<br />

130871 Reamer 40<br />

130873 Reamer 42<br />

130875 Reamer 44<br />

130877 Reamer 46<br />

130879 Reamer 48<br />

130881 Reamer 50<br />

130883 Reamer 52<br />

130885 Reamer 54<br />

130887 Reamer 56<br />

130889 Reamer 58<br />

130891 Reamer 60<br />

130893 Reamer 62<br />

130895 Reamer 64<br />

130897 Reamer 66<br />

130899 Reamer 68<br />

130822 Impactor head 22<br />

130823 Impactor head 28<br />

130824 Impactor head 32<br />

130848 Impactor head 36<br />

130818 Inserter/Impactor<br />

130802 Adapter for PE insert, standard, to 130818 40 – 44<br />

130803 Adapter for PE insert, standard, to 130818 46 – 48<br />

130804 Adapter for PE insert, standard, to 130818 50 – 68<br />

130806 Adapter for PE insert, hooded, to 130818 46 – 48<br />

130807 Adapter for PE insert, hooded, to 130818 50 – 68<br />

28


3<br />

5<br />

2 1<br />

4<br />

6<br />

29


Case 2<br />

2 A Basic Case: Trial inserts<br />

Art. No. Description Ø Size<br />

131001 Basic Case II (without cover)<br />

130999 Cover for <strong>EP</strong>-<strong>FIT</strong> PLUS ® case<br />

130989 Adapter for ME insert, standard, to 130818 46<br />

130990 Adapter for ME insert, standard, to 130818 48<br />

130991 Adapter for ME insert, standard, to 130818 50 – 52<br />

130992 Adapter for ME insert, standard, to 130818 54 – 56<br />

130993 Adapter for ME insert, standard, to 130818 58 – 68<br />

130826 Trial insert, standard 22 mm 40 – 44<br />

130827 Trial insert, standard 22 mm 46<br />

130828 Trial insert, standard 22 mm 48<br />

130829 Trial insert, standard 22 mm 50<br />

130830 Trial insert, standard 28 mm 46<br />

130831 Trial insert, standard 28 mm 48<br />

130832 Trial insert, standard 28 mm 50 – 52<br />

130833 Trial insert, standard 28 mm 54 – 56<br />

130834 Trial insert, standard 28 mm 58 – 68<br />

130835 Trial insert, standard 32 mm 50 – 52<br />

130836 Trial insert, standard 32 mm 54 – 56<br />

130837 Trial insert, standard 32 mm 58 – 68<br />

660121 Trial insert, standard 36 mm 50 – 52<br />

660122 Trial insert, standard 36 mm 54 – 56<br />

660123 Trial insert, standard 36 mm 58 – 68<br />

130850 Trial insert, hooded 28 mm 46<br />

130851 Trial insert, hooded 28 mm 48<br />

130852 Trial insert, hooded 28 mm 50 – 52<br />

130853 Trial insert, hooded 28 mm 54 – 56<br />

130854 Trial insert, hooded 28 mm 58 – 68<br />

130855 Trial insert, hooded 32 mm 50 – 52<br />

130856 Trial insert, hooded 32 mm 54 – 56<br />

130857 Trial insert, hooded 32 mm 58 – 68<br />

30


3<br />

1<br />

2<br />

31


2 B Tray: Bone screws and accessories<br />

Art. No. Description Ø Length<br />

130995 Tray to Case 131001<br />

130490 Flexible drill shaft for quick coupling<br />

130847 Drill guide for screws 3,2 mm<br />

130708 Depth gauge for screws<br />

130732 Screw-holding forceps<br />

130710 Screwdriver, hexagon W 3,5 mm<br />

130492 Twist drill 3,2 mm 56 mm<br />

130493 Twist drill 3,2 mm 70 mm<br />

130496 Cardan screwdriver, hexagon W 3,5 mm<br />

131002 Container for cancellous bone screws to tray 130995<br />

32


6<br />

8<br />

4<br />

7<br />

5<br />

2<br />

3 3<br />

1<br />

33


Case 3<br />

3 A Basic Case: Instruments and trial shells (identical to 1A)<br />

Art. No. Description Size<br />

131000 Basic Case III (without cover)<br />

130999 Cover for <strong>EP</strong>-<strong>FIT</strong> PLUS ® case<br />

130707 Shell inserter, standard version<br />

130705 Insertion/Extraction hammer<br />

130728 Shell alignment guide, standard version<br />

130731 Depth gauge for shell<br />

130734 Trial shell 40<br />

130735 Trial shell 42<br />

130712 Trial shell 44<br />

130713 Trial shell 46<br />

130714 Trial shell 48<br />

130715 Trial shell 50<br />

130716 Trial shell 52<br />

130717 Trial shell 54<br />

130719 Trial shell 56<br />

130720 Trial shell 58<br />

130721 Trial shell 60<br />

130723 Trial shell 62<br />

130724 Trial shell 64<br />

130736 Trial shell 66<br />

130737 Trial shell 68<br />

130820 Extraction instrument for metal/ceramic insert, to 130818 46<br />

130794 Extraction instrument for metal/ceramic insert, to 130818 48<br />

130795 Extraction instrument for metal/ceramic insert, to 130818 50 – 52<br />

130796 Extraction instrument for metal/ceramic insert, to 130818 54 – 56<br />

130797 Extraction instrument for metal/ceramic insert, to 130818 58 – 68<br />

34


3<br />

3<br />

5 4<br />

2<br />

6<br />

1<br />

35


3 B Tray: Reamer (1 mm increments) Sizes 40 – 43 and 66 – 69<br />

Art. No. Description Size<br />

130998 Tray to Case 131000<br />

130987 Shell Inserter<br />

130975 Adapter, to 130987 40 – 44<br />

130976 Adapter, to 130987 46<br />

130977 Adapter, to 130987 48<br />

130978 Adapter, to 130987 50 – 52<br />

130979 Adapter, to 130987 54 – 56<br />

130980 Adapter, to 130987 58 – 68<br />

130897 Reamer 66<br />

130898 Reamer 67<br />

130899 Reamer 68<br />

130900 Reamer 69<br />

130871 Reamer 40<br />

130872 Reamer 41<br />

130873 Reamer 42<br />

130874 Reamer 43<br />

130822 Impactor head 22<br />

130823 Impactor head 28<br />

130824 Impactor head 32<br />

130848 Impactor head 36<br />

130802 Adapter for PE insert, standard, to 130818 40 – 44<br />

130803 Adapter for PE insert, standard, to 130818 46 – 48<br />

130804 Adapter for PE insert, standard, to 130818 50 – 68<br />

130806 Adapter for PE insert, hooded, to 130818 46 – 48<br />

130807 Adapter for PE insert, hooded, to 130818 50 – 68<br />

130818 Inserter/Impactor<br />

130858 Shell alignment guide (US version)<br />

36


4<br />

8<br />

8<br />

8<br />

3<br />

1<br />

5<br />

2<br />

7<br />

6<br />

37


3 C Tray: Reamer (1 mm increments) Sizes 44 – 45<br />

Art. No. Description Size<br />

130997 Tray to Case 131000<br />

130870 Drive shaft<br />

130875 Reamer 44<br />

130876 Reamer 45<br />

130877 Reamer 46<br />

130878 Reamer 47<br />

130879 Reamer 48<br />

130880 Reamer 49<br />

130881 Reamer 50<br />

130882 Reamer 51<br />

130883 Reamer 52<br />

130884 Reamer 53<br />

130885 Reamer 54<br />

130886 Reamer 55<br />

130887 Reamer 56<br />

130888 Reamer 57<br />

130889 Reamer 58<br />

130890 Reamer 59<br />

130891 Reamer 60<br />

130892 Reamer 61<br />

130893 Reamer 62<br />

130894 Reamer 63<br />

130895 Reamer 64<br />

130896 Reamer 65<br />

Note<br />

Case 1 may be replaced by case 3 if a reamer with 1 mm increments is required.<br />

38


2<br />

1<br />

39


40<br />

Notes


Distribution<br />

Sales Partners in:<br />

Australia<br />

Baltic countries (EE, LT, LV)<br />

Belarus<br />

Bosnia<br />

Brazil<br />

Bulgaria<br />

India<br />

Indonesia<br />

Iran<br />

Croatia<br />

Kuwait<br />

Malaysia<br />

Norway<br />

Russia<br />

Slovakia<br />

Slovenia<br />

South Africa<br />

South Korea<br />

Thailand<br />

Czech Republic<br />

Turkey<br />

Belgium<br />

Plus Orthopedics Belgium Sprl<br />

Rue du Bosquet, 2, P.I Nivelles Sud, 1400 – Nivelles<br />

Phone +32 67 879 500, Fax +32 67 646 640<br />

China<br />

Plus Orthopedics (Beijing) Co., Ltd.<br />

7th Floor, Modern Palace, No. 20 Daluyuan<br />

Dongsanhuan Nanlu, Chaoyang District<br />

Beijing 100022, P.R. China<br />

Phone +86 10 8778 3322, Fax +86 10 6776 3622<br />

Germany<br />

Plus Orthopedics GmbH<br />

Mainstrasse 2, 45768 Marl<br />

Phone +49 2365 91 81 0, Fax +49 2365 91 81 10<br />

France<br />

Plus Orthopedics France Sarl (new address from 1 st April, 2006)<br />

14, Villa des Fleurs, 92400 Courbevoie<br />

Phone +33 1 49 97 04 60, Fax +33 1 47 68 09 36<br />

Greece<br />

Plus Orthopedics Hellas S.A.<br />

Kleanthous Street 8, GR 16346 Ilioupoli, Athina<br />

Phone +30 2 10 99 13 190, Fax +30 2 10 99 31 809<br />

United Kingdom<br />

Plus Orthopedics (UK) Limited<br />

Barbury House, Stonehill Green, Westlea, Swindon SN5 7HB<br />

Phone +44 1793 719 222, Fax +44 1793 619 222<br />

Italy<br />

Plus Orthopedics Italy Srl<br />

Via Archimede 76, 20041 Agrate Brianza (MI)<br />

Phone +39 039 657 921, Fax +39 039 657 92 35<br />

Japan<br />

Plus Orthopedics K.K.<br />

Tomigaya-Ogawa Bldg. 2-41-12, Tomigaya<br />

Shibuya-ku, Tokyo 151-0063<br />

Phone +81 3 3467 5581, Fax +81 3 3467 5582<br />

The Netherlands<br />

Plus Orthopedics Netherlands BV<br />

Postbus 785, 2700 AT Zoetermeer<br />

Phone +31 793 41 7071, Fax +31 793 42 5601<br />

Austria<br />

Plus Orthopedics GmbH<br />

Grenzgasse 38a, 2340 Mödling<br />

Phone +43 (0)2236/48 407-0, Fax +43 (0)2236/41 149-4<br />

Switzerland<br />

Plus Orthopedics Schweiz AG<br />

Erlenstrasse 4a, 6343 Rotkreuz<br />

Phone +41 (0)41 798 41 11, Fax +41 (0)41 798 41 00<br />

Spain<br />

Plus Orthopedics España S.A.<br />

c/Islas Aleutianas n 4, 28035 Madrid<br />

Phone +34 91 376 86 20, Fax +34 91 376 86 21<br />

USA<br />

Plus Orthopedics USA, Inc.<br />

10188 Telesis Court, San Diego, CA 92121<br />

Phone +1 858 550 3800, Fax +1 858 457 56 18<br />

Switzerland<br />

Plus Orthopedics AG (Manufacturer)<br />

Erlenstrasse 4a, 6343 Rotkreuz<br />

Phone +41 (0)41 798 41 11, Fax +41 (0)41 798 41 00<br />

info@plusorthopedics.com<br />

www.plusorthopedics.com<br />

Technical changes reserved<br />

Lit. No. 1258-e Ed. 09/05 1000 Ex. 03/06

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