The FDA issued a safety communication on risks associated with the Scandinavian Total Ankle Replacement device, manufactured by Stryker.
Five details:
1. The device received premarket approval, but after examining later studies, the FDA found a higher than expected risk of the plastic component breaking three to four years after implantation. Patients may need additional surgery if the device breaks.
2. The FDA said the device is still appropriate for some patients, including older patients who have low activity levels. Younger and more active patients are at higher risk for the plastic component to break, according to the statement.
3. The plastic component fractured 13.8 percent of the time in a study of 87 patients made after the device's premarket approval.
4. Fractures were more common among the thinner plastic components than the thicker components.
5. The agency recommended surgeons monitor patients who receive the STAR device for adverse outcomes.