FDA is advising patients and healthcare providers about the risk of the plastic component in Scandinavian Total Ankle Replacement devices (STAR Ankle) breaking as early as three to four years after implantation:
Based on the FDA’s recent analysis of FDA-required post approval studies and adverse event reports, the potential risk of the plastic component breaking may exist for all STAR Ankle devices, regardless of the date of manufacture or distribution.
Surgeons should closely monitor patients with the STAR Ankle for potential fractures of the plastic component of the device.
If surgeons suspect a fractured plastic component (for example, there is pain or noise from the device), consider performing X-rays to further evaluate the device integrity. Changes on X-rays can be subtle; if X-rays are negative and a polyethylene fracture is still suspected, a CT scan may be needed to determine whether a plastic component fracture has occurred. Be aware that the clinical presentation (the presence of signs or symptoms) of fracture in plastic materials such as polyethylene can be subtle even in a CT scan and, infrequently, may be diagnosed only on exploratory surgery.
Read more from the FDA.