Johnson & Johnson DePuy S-ROM Información Importante página 5

NOTE: If the Poly-Dial liner is not properly seated and locked, dislocation may occur.
Installation of Apical Hole Plug
Note: Apical Hole Plugs are only for use with ZTT I and ZTT II acetabular shells.
1. After implanting the ZTT acetabular shell, clear cement, blood and debris from the apical
hole of the cup.
2. Use a suction device to lift and place the Apical Hole Plug in the apical hole with the
convex side marked "LAT" visible.
3. Place the Apical Hole Plug Impactor in contact with the Apical Hole Plug and strike with
a mallet to secure the plug in the shell.
4. Remove the impactor and ensure that the plug is properly seated.
Warnings
Improper prosthesis selection or alignment, inadequate fixation, use where contraindicated,
or in patients whose medical, physical, mental, or occupational conditions will likely result in
extreme stresses to the implant, may result in premature failure due to loosening, fracture,
or wear. Postoperative care is extremely important. The patient should be instructed on the
limitations of the device and should be cautioned regarding load bearing, ranges of motion,
and activity levels permissible. Early motion and load bearing should be carefully monitored.
Use of other manufacturers' components with this implant is not advised. Use of com-
ponents other than those recommended could lead to loosening, wear, fracture during
assembly, and premature failure.
Implants must never be tampered with since bending, contouring, or other modifications
may adversely affect the implant causing early failure of the implant.
Inspect implants for nicks, scratches or other defects that may cause failure of the implant.
The Standard Profile Head 6.5mm bone screw cannot be used with the 48DP (M series), or
the 51DP (L series), Arthopor II shells as it will prevent correct seating of the polyethylene
liner in the cup.
Refer to "Precautions" for important component compatibility information. Failure to
adhere to the compatibility recommendations will result in poor function, loosening,
wear, fracture, or premature failure.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of
a physician.
Precautions
To prevent contamination of this prosthesis, keep free of lint and powders. Do not open
the package until surgery. Do not place the implant in contact with prepared bone surfaces
before the final decision to implant has been made.
An implant should never be reused. Any implant once used, should be discarded. Even
though it appears undamaged, it may have small defects and internal stress patterns that
may lead to failure. Likewise, a new implant should be handled carefully to avoid damage
that could compromise the mechanical integrity of the device and cause early failure or
loosening.
The wear rate of prosthesis contact surfaces is greatly accelerated if loose fragments of
bone cement become detached and act as an abrasive in the bearing surfaces. When using
bone cement, care should be taken to remove all excess cement from the periphery of the
implant.
A complete intraoperative test of range or motion should be performed to rule out impinge-
ment of the femoral neck on the liner.
Ensure that the series letter of the shell matches the series letter of the liner (i.e., M series
shells are only for use with M series liners).
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