Integra Cadence Total Ankle System, Manual

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4
EN – ENGLISH
MDR Reporting Reminder: Medical device manufacturers and
users are required by law and regulation to report serious
injuries and death.
Post-Operative Care
Preventative actions for the patient to avoid post-operative
complications:
• Avoid extreme motion in flexion-extension
• Wear external immobilization (plaster, splint…) according
to the surgeon’s prescription.
• Receive prompt medical attention for any infection that
could occur, whether at the operated-member level or
elsewhere in the body.
The patient should be encouraged to report to his/her
surgeon any unusual changes of the operated extremity. If
evidence suggests loosening of the implant (particular pain
and progressive changes in the radiographs) an intensified
schedule of check-ups is advised and new warning and
instructions to the patient may be appropriate regarding
further activity restrictions.
Excessive physical activity and trauma affecting the operated
extremity have been implicated in the premature failure of
joint arthroplasty as a result of position change, fracture and/
or wear and tear of the implant.
Sterility
The Cadence Total Ankle System prosthesis components
are supplied sterile. The metal components are sterilized by
gamma radiation, and the polymer (UHMWPE) components
are sterilized by ethylene oxide (EO) gas.
If either the implant or the package appears to be damaged, or
has been opened, or if sterility is questioned for any reason,
the implant should not be used. Re-sterilization of this
product is not recommended.
Inner packaging should be handled under sterile conditions
(persons/instruments).
Do not re-sterilize this product.
Storage
All implants must be stored in a clean, dry environment and be
protected from sunlight and extremes in temperature.
Surgical Procedure
A Surgical Technique brochure is available which outlines
the basic procedure for device implantation and use of the
specialized surgical instrumentation. It is the responsibility
of the surgeon to be familiar with the procedure before
use of these products. Each surgeon must evaluate the
appropriateness of the surgical technique used based on
personal medical training and experience.
Meticulous preparation of the implant site and selection of
the proper size implant increase the potential for successful
reconstruction. A complete set of instruments for each type
of implant is available to aid bone preparation and reduce the
operative time. It is suggested that the proper size implant be
removed from its sterile package only after the implant site
has been prepared and properly sized.
Training
Surgeons may obtain training from a qualified instructor