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The U.S. Food and Drug Administration on Monday issued a safety advisory on Stryker’s Scandinavian Total Ankle Replacement, or STAR Ankle, devices, citing the risk of a plastic component breaking after surgical implantation.

According to the FDA, the plastic component may break as soon as three to four years after the STAR Ankle is inserted, which may lead to surgery to repair or replace the device.

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The agency noted that plastic component fractures in the device may be attributed to multiple issues, including the thickness of the component, degradation of the material, surgical factors and patient factors, such as younger patients with higher activity levels.

“… all patients who have the device implanted or are considering getting the device should be aware of the risk of plastic component fracture, which may subsequently require re-operation,” the FDA stated.

The agency also noted that the “potential risk of the plastic component breaking may exist for all STAR Ankle devices, regardless of the date of manufacture or distribution.”

Click here to read the FDA’s “Recommendations for Patients Who Have or are Considering the STAR Ankle”