Scandinavian Total Ankle Replacement (STAR® Ankle)

The Scandinavian Total Ankle Replacement (STAR Ankle) is intended for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. For detailed information concerning the product(s), please refer to the dedicated operative technique.

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 in 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 at the surgical site.

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 shall 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 (113kg). • Always confirm 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 sterile packaged product. Do not use implants, components or sterile packaged instruments 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. • For a minimum of two weeks after surgery, the patient should not bear any weight on the implanted STAR 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. • Single use is defined as use of one implant or instrument on a single patient in a single surgical procedure. • Reuse of instruments designated as single use has been associated with necrosis of bone leading to implant failure. It may also lead to sepsis and/or communication of potentially lethal viruses. • Reuse of implants designated as single use has been associated with sepsis and/ or communication of potentially lethal viruses.

6 Potential adverse effects of the device on health Reported device related adverse effects The most commonly reported adverse effects associated with the STAR Ankle are the following:

• Bone fracture (talus, tibia)
• Pain and nerve injury
• Mobile bearing fracture
• Device loosening (tibial plate, talar component)
• Instability
• Device subsidence.

A complete list of frequency and rate of complications and adverse events identified in the clinical study are provided in the Overall Safety section (Table 5). 7 Potential adverse effects

The following adverse effects may occur in association with total ankle replacement surgery including the STAR Ankle:

• Device failure
• Dislocation
• Loosening of any of the components
• Fatigue fracture of the implants
• Peripheral neuropathies, nerve damage, circulatory compromise
• Heterotopic bone formation
• Surgical complications including, but not limited to: vascular disorders, thrombophlebitis, hematoma or damage to blood vessels resulting in blood loss, or death
• Delayed wound healing
• Superficial or deep infection at any point in time post-operatively
• Adverse effects may necessitate reoperation, revision, arthrodesis of the involved ankle, and/or amputation of the ankle
• Intra-operative or post-operative bone fracture
• Wear deformation of the articular surface
• Damage to ligamentous, tendinous, and surrounding soft tissues
• Osteolysis and/or other periprosthetic bone loss
• Metal sensitivity reactions or allergic reactions or metallosis
• Limb length discrepancy
• Increased ankle pain and/or reduced ankle function
• Progression of adjacent joint arthritis
• Progressive mal-alignment
• Altered gait.

Any of these adverse effects may require medical or surgical intervention.