•
ATTUNE Patella Component:
o
Sizes 38mm and 41mm may be used with all femoral component sizes.
o
Size 29mm may only be used with femoral component sizes 1 through 3.
o
Size 32mm may only be used with femoral component sizes 1 through 6.
o
Size 35mm may only be used with femoral component sizes 1 through 8.
•
Implants and trial components from different manufacturers or implant systems should
never be used together.
•
Knee prosthesis components should never be reimplanted. Even though the implant
appears undamaged, the implant may have developed microscopic imperfections which
could lead to failure.
•
Always use a trial prosthesis for trial purposes. Trials should not be assembled with any
components intended for permanent implantation. Trials must have the same
configuration size, as the corresponding components to be permanently implanted.
•
Do not alter or modify implants in any way.
•
Avoid drilling multiple pin holes in the proximal tibia which may affect the compressive
strength of the tibia.
NOTE: DePuy's Single Use devices have not been designed to undergo or withstand any form
of alteration, such as disassembly, cleaning or re-sterilization, after a single patient use. Reuse
can potentially compromise device performance and patient safety.
CAUTION: The following conditions, singularly or concurrently, tend to impose severe loading
on the affected extremity thereby placing the patient at higher risk of failure of the knee
replacement:
1.
Obesity or excessive patient weight.
2.
Manual labor.
3.
Active sports participation.
4.
High levels of patient activity.
5.
Likelihood of falls.
6.
Alcohol or drug addiction.
7.
Other disabilities, as appropriate.
In addition to the above, the following physical conditions, singularly or concurrently, tend to
adversely affect the fixation of knee replacement implants:
1.
Marked osteoporosis or poor bone stock.
2.
Metabolic disorders or systemic pharmacological treatments leading to progressive
deterioration of solid bone support for the implant (e.g., diabetes mellitus, steroid
therapies, immunosuppressive therapies, etc.).
3.
History of general or local infections.
4.
Severe deformities leading to impaired fixation or improper positioning of the implant.
5.
Tumors of the supporting bone structures.
6.
Allergic reactions to implant materials (e.g., bone cement, metal, polyethylene).
7.
Tissue reactions to implant corrosion or implant wear debris.
8.
Disabilities of other joints (i.e., hips or ankles).
A higher incidence of implant failure has been reported in paraplegics and in patients with cerebral
palsy or Parkinson's Disease.
When the surgeon determines that knee replacement is the best medical option available and
decides to use this prosthesis in a patient who has any of the above conditions or who is
simply young and active, it is imperative that the patient be instructed about the strength
limitations of the materials used in the device and for fixation and the resultant need to
substantially reduce or eliminate any of the above conditions.
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