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Contraindications, Warnings/Precautions & Post-Operative Management

The STAR™ Ankle is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.

Contraindications

  • Active or prior deep infection in the ankle joint or adjacent bones
  • Skeletal immaturity
  • Bone stock inadequate to support the device including:
    • Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
    • Avascular necrosis of the talus
    • Prior surgery and/or injury that has adversely affected ankle bone quality
  • Malalignment or severe deformity of involved or adjacent anatomic structures including:
    • Hindfoot or forefoot malalignment precluding plantigrade foot
    • Significant malalignment of the knee joint
  • Insufficient ligament support that cannot be repaired with soft tissue stabilization
  • Neuromuscular disease resulting in lack of normal muscle function about the affected ankle
  • Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
  • Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
  • Prior arthrodesis at the ankle joint
  • Poor skin and soft tissue quality about the surgical site

Warnings/Precautions

  • Only implant the STAR™ Ankle after adequate training and familiarity with the surgical technique manual, to avoid increased risk of device failure due to improper surgical technique.
  • Do not use STAR™ Ankle components in combination with prosthesis components made by other manufacturers, because design, material, or tolerance differences may lead to premature device and/or functional failure. Components of the system have been specifically designed to work together.
  • To ensure proper implantation of the STAR™ Ankle, use the instrumentation that is supplied with the system in accordance with the surgical technique manual.
  • The trial prostheses should not be implanted.
  • Examine instruments for wear or damage before use. While rare, intra-operative instrument breakage may occur. Instruments that have experienced excessive use or force may be susceptible to breakage.
  • The safety and efficacy of the STAR™ Ankle have not been studied in patients weighing > 250 lbs.
  • Always determine that the patient does not have a possible allergy to the implant/prosthesis material before selecting the STAR™ implant to minimize the risk of an allergic response.
  • Discard all damaged or mishandled implants. Do not reuse implants and components. Although the implant may appear undamaged, it may have small defects and internal stress patterns which may lead to early failure of the device.
  • Do not resterilize. Do not use implants or components if the package is damaged or has been opened prior to planned use.
  • Always exercise care in selecting the proper type and size of implant. Size and shape of the human bone place restrictions on the size and shape of the implant, potentially limiting device function.
  • Do not contour or bend an implant because it may reduce its fatigue strength and cause failure under load. Correct handling of the implant is extremely important.
  • Immediately post-operative through two weeks, a patient should not bear any weight on the implanted STARâ„¢ Ankle. Certain vigorous physical activities (e.g.,  basketball, football) and trauma to the joint replacement may cause early failure of the STAR™ Ankle. Please refer to the section titled "Post-operative Management" for additional restrictions.
  • Appropriate selection, placement and fixation of the STAR™ Ankle components are critical factors which affect implant service life. Improper selection, placement and fixation of the implant components may result in early implant failure. As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanic and other extrinsic factors which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions and warnings for this product is essential to potentially maximize service life.

Post-Operative Management

For a minimum of two weeks after surgery, the patient should not bear weight on the operated ankle. The patient should keep the ankle elevated as much as possible while limiting all physical activities. Partial weight-bearing may begin at 2 to 3-weeks post-operative and gradually increase until the patient is fully weight-bearing at 4 to 6-weeks post-operative. The ankle cast should typically be removed six weeks post-operative.

CAUTION: FEDERAL LAW RESTRICS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

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