Johnson & Johnson DePuy S-ROM Información Importante página 4

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Description
The S-ROM Total Hip System – Porous-Coated Acetabular Shells (ZT™ I, ZTT II, Super-
®
Cup™, Arthopor™ I, Arthopor II and Arthopor II Oblong) are a part of a modular system for
use in total hip replacement. The acetabular component is provided as two separate units,
an outer shell composed of titanium alloy (Ti-6Al-4V) with a commercially pure titanium
porous coating (CP Ti) and a Poly-Dial
MWPE), which fits into the outer shell. The acetabular component articulates with a femoral
stem and a femoral head of an appropriate diameter, all distributed by your local DePuy
sales representative or distributor.
S-ROM acetabular shells and liners are available in S series, M series, L series, and XL
series configurations.
The acetabular shell has a porous-coated surface and is provided in a variety of diameters
and configurations that accept liners for 22.225, 26, 28 and 32mm femoral head sizes; 0°,
10°, 15°, and 20° lips; in constrained, nonconstrained, and lateralized versions.
Also available for use are an apical hole plug, locking pins, and a variety of bone screws,
composed of titanium.
Indications and Usage
The S-ROM acetabular components are indicated for use in total hip replacement proce-
dures for patients suffering severe pain and disability due to structural damage in the hip
joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders,
avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indi-
cated for revision of previous hip arthroplasty and for patients with congential hip dysplasia,
protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion,
where bone stock is inadequate for other reconstruction techniques.
All porous acetabular shells are indicated for cementless application.
Information for Use
An instrumentation system, as well as a system of trial components, is available to assure
proper fit and orientation of the prosthesis. Correct fit and orientation will reduce stresses at
interface surfaces to enhance implant fixation. The surgeon should refer to the appropriate sur-
gical technique manual for details on the use of the instrument system and implantation of the
prosthesis. This manual is available from your local DePuy sales representative or distributor.
Installation of the Poly-Dial Liner
1. To install the Poly-Dial liner in the S-ROM Acetabular shell, align the lugs of the liner
between the peripheral screw holes of the shell, and push inward without turning. When
the liner is fully seated, only four lugs will sit above the rim of the shell.
2. The liner should turn readily so long as it is cooler than 70°F (21°C). Higher temperatures
cause the plastic liner to expand and become tight. The Poly-Dial liner should be stored
in a freezer prior to surgery to ensure ease of insertion.
3. After the liner has been turned to one of the six possible positions, carefully align the
lugs of the liner with the peripheral screw holes of the shell, and insert screws and/or
locking pins in at least two holes to lock the liner in position. Four Cruciate Head Periph-
eral Screws are recommended for 20° Poly-Dial liners.
INSTRUCTIONS FOR USE
liner of ultrahigh molecular weight polyethylene (UH-
®
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