FDA Issues Safety Advisory Against Stryker STAR Ankle Devices

On Monday, March 15, 2021, The U.S. Food and Drug Administration (FDA) issued a safety advisory to patients and health care providers, warning of breakage risks that affect all Stryker Scandinavian Total Ankle Replacement (STAR) devices.

In the letter, the FDA warned of a “higher than expected” risk of the polyethylene plastic components in the device breaking as early as three to four years after implantation. The FDA cited a recent analysis discovered through the mandatory post approval studies and adverse event report as the reason for the new advisory.

The FDA highlighted patients with joint issues such as osteoarthritis, more active lifestyles, and individuals younger than 55 as being particularly at risk:

Based on the additional medical literature and real-world evidence, patients with more active life styles, osteoarthritis (disease where the protective joint tissue breaks down and causes pain and swelling), or age younger than 55 years old may have a higher than expected risk of the plastic component breaking.

The FDA is advising patients currently implanted with Stryker STAR devices to contact their health care provider if new or worsening pain, instability, or inability to bear weight develop. Patients who have experienced breakage may report the failure through their online reporting system.

At least 1,841 adverse event reports against Stryker’s STAR devices have been reported to the FDA since 2009, with around 300 reports specifically describing fracturing of the plastic components.

This is far from the first safety alert issued against a Stryker implant. We reported in 2016 about an expected recall on Stryker’s LFIT V40 hip replacement system, after the Australian Therapeutic Goods Administration issued a similar hazard alert. As with the STAR ankle devices, a higher-than-expected rate of failure was cited as the reason behind the alert.