FDA Warns of Vulnerabilities in Stryker’s Total Ankle Replacement System

The FDA has issued an advisory notice for Stryker’s Scandinavian Total Ankle Replacement (STAR) device, warning that one of its plastic components has a higher-than-expected risk of breakage. Stryker last year sold off the STAR product line to Colfax.

Base on long-term data from a postapproval study, real-world evidence, adverse event reports and published literature, the agency concluded that a plastic component in the device has a potential risk of fracture that can occur as early as three to four years following implantation. The eight-year study showed that 13.8 percent of devices had a plastic-component fracture at eight years postimplantation. The agency called the higher fracture rate and earlier-than-expected rate of fracture “concerning” when compared with other total ankle replacement systems.

The FDA is not currently recommending that any STAR implants be removed, saying it is still appropriate for certain patients, such as older patients who are less active. But it is advising patients implanted with the device to contact their surgeon if they experience new or worsening pain or instability.