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2. Patients that have a known sensitivity to materials typicallyused in
orthopedic prosthetic devices or bone cements.
Relative contraindications include:
1. Uncooperative patient or patient incapable of following pre-operative
and post-operative instructions.
2. Osteoporosis.
3. Metabolic disorders which may impair the formation or healing of
bone.
4. Infections at remote sites which may spread to the implant site.
5. Rapid joint destruction or bone resorption visible on roentgenogram.
6. Chronic instability or deficient soft tissues and other support
structures.
7. Vascular or muscular insufficiency.
8. Inadequate skin, musculotendinus or neurovascular system status.
Warnings
Improper selection, placement, positioning, alignment, and fixation of
the implant components may reduce the service life of the prosthetic
components. Inadequate preparation and cleaning of the implant
components mating surfaces may result in improper fixation of the device.
Improper handling of theimplants can produce scratches, nicks or dents
that may have adverse clinical effects on mating joint surfaces. Do not
modify implants. The surgeon shall be thoroughly familiar with the
implants, instruments, and surgical technique prior to performing surgery.
The all-polyethylene tibial component is intended to be used in conjunction
with activity restrictions.
When taking readings of articular surfaces, care should betaken to ensure
that the distal tip of contact probe is making contact on articular surfaces
and free from any soft tissue structures to ensure accuracy. Use light
pressure on contact probe to slightly indent articular surface at chosen
points, this will ensure selected implant will be recessed just below
articular surface at margins of implant.
When placing implant, carefully trim articular cartilage debris around
margin of implant. Remove bone particles and lavage thoroughly. To
ensure mechanical interlock of the taper post and implant, carefully clean
taper post with provided instruments. All drilling or reaming should be
done with vigorous lavage to minimize heat effects to adjacent bone and
cartilage tissues.
