EP-FIT PLUS® - CMM SL
EP-FIT PLUS® - CMM SL EP-FIT PLUS® - CMM SL
Know-how brings motion back to life. SM EP-FIT PLUS ® Non-cemented press-fit Acetabular Cup System Surgical Technique
- Page 3: Table of Contents 1 Foreword 3 2 In
- Page 6 and 7: 2. Indications All forms of osteoa
- Page 8 and 9: 6. Surgical Technique Note Users of
- Page 10 and 11: 6. Determination of the implant siz
- Page 12 and 13: 8. Implantation of the titanium she
- Page 14 and 15: 13.a Placement of the standard poly
- Page 16 and 17: Placement of the ceramic insert The
- Page 18 and 19: 15. Use of the PLUSMET ® metal ins
- Page 20 and 21: 16. Revision of the metal/ceramic i
- Page 22 and 23: 10. Implants Shells Shell Ti-plasma
- Page 24 and 25: Inserts Note All cup inserts must o
- Page 26 and 27: Ball heads Ceramic ball heads, BIOL
- Page 28 and 29: 11. Instrumentation Case 1 1 A Basi
- Page 30 and 31: 1 B Tray: Reamer (2 mm increments)
- Page 32 and 33: Case 2 2 A Basic Case: Trial insert
- Page 34 and 35: 2 B Tray: Bone screws and accessori
- Page 36 and 37: Case 3 3 A Basic Case: Instruments
- Page 38 and 39: 3 B Tray: Reamer (1 mm increments)
- Page 40 and 41: 3 C Tray: Reamer (1 mm increments)
- Page 42: 40 Notes
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