DePuy Synthes ATTUNE Instrucciones De Empleo página 4

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
DEVICE DESCRIPTION
A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar
components designed to replace the natural articular surface of the knee joint. The femoral
component is a metal implant without a porous coating. The tibial component may be an all
polyethylene component or comprised of a metal tibial base without porous coating, and a
polyethylene insert and locking components. The patella component may be of an all
polyethylene design.
INTENDED USE
Total knee arthroplasty is intended to provide increased patient mobility and reduced pain by
replacing the damaged knee joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components. Total knee replacement may be considered
for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee
replacement outweighs the risks associated with the age of the patient, and if limited
demands regarding activity and knee joint loading can be assured. This includes severely
crippled patients with multiple joint involvement for whom a gain in knee mobility may lead
to an expectation of significant improvement in the quality of their lives.
INDICATIONS
Candidates for total knee replacement include patients with a severely painful and/or severely
disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a
failed previous implant.
CONTRAINDICATIONS
The following conditions are contraindications for total knee replacement:
1. Active local or systemic infection.
2. Loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular
deficiency in the affected limb in sufficient degree to render the procedure unjustifiable
(e.g., absence of musculoligamentous supporting structures, joint neuropathy).
3. Severe instability secondary to advanced loss of osteochondral structure or the absence
of collateral ligament integrity.
NOTE: Diabetes, at present, has not been established as a contraindication. However, because
of the increased risk for complications such as infection, slow wound healing, etc., the
physician should carefully consider the advisability of knee replacement in the severely
diabetic patient.
WARNINGS AND PRECAUTIONS
CAUTION:
• ATTUNE® CR Tibial Insert size should be the same size as the selected ATTUNE CR Femoral
Component size. ATTUNE CR Tibial Inserts should be within 2 sizes of the ATTUNE
Tibial Base.
•
ATTUNE PS Tibial Insert size should be the same size as the selected ATTUNE PS Femoral
Component size. ATTUNE PS Tibial Insert should be within 2 sizes of the
ATTUNE Tibial Base.
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