FDA warns of potential polyethylene fracture with STAR total ankle device
Click Here to Manage Email Alerts
According to an FDA safety communication, all Scandinavian Total Ankle Replacement devices – known as the STAR Ankle from Stryker – had a higher-than-expected risk of polyethylene component fracture.
The FDA release noted surgeons should closely monitor patients with the STAR Ankle for potential fractures of the polyethylene component of the device and consider performing X-rays to evaluate device integrity if polyethylene component fracture is suspected.
“The FDA continues to work with Stryker to better understand the factors which contribute to the plastic component fracture based on results from post-approval studies and other data sources,” according to the release. “The FDA will also continue to review medical literature, real-world evidence, FDA-required post-approval studies, adverse event reports, registry data and information from patients, health care providers, orthopedic professional societies and the manufacturer.”
Indicated for use as a non-cemented total ankle prosthetic and used to replace painful arthritic ankle joints due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis, the STAR Ankle is designed to allow for some normal ankle mobility and function, according to the release. Although approved in the premarket approval application, the release noted post-approval studies revealed a cumulative fracture rate of 13.8% of the polyethylene component at 8 years after implantation. The post-approval studies also showed fracture as early as 3 to 4 years after implantation.
In August 2014, Stryker made changes to the inner-pouch foil packaging to limit the material degradation of the polyethylene component. Although the post-application studies did not include any devices manufactured after August 2014, patients should still be made aware of the risk of polyethylene component fracture, which may be attributed to device design, material, surgical factors and patient factors, according to the FDA, which said the fractures may lead to surgery to repair or replace the device.
Despite the risk of polyethylene component fracture, the FDA noted the STAR Ankle may be appropriate for certain patient populations, including older patients with lower activity levels. Patients with more active lifestyles, OA or who are younger than 55 years old may have a higher-than-expected risk of polyethylene component fracture, according to the release.
Read more about
Click Here to Manage Email Alerts