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FDA Warns Plastic Component Count Break in Stryker’s STAR Ankle Implants

FDA Warns Plastic Component Count Break in Stryker's STAR Ankle Implants

The U.S. Food and Drug Administration (FDA) today issued a warning regarding STAR ankle implants, which were previously made by Stryker, saying that there is a potential that the plastic component in these devices could break. According to the FDA alert, there is a “higher-than-expected” risk of the polyethylene or plastic component of the device breaking as early as three to four years after implantation, which can lead to surgery in order to repair it or a mandatory replacement.

STAR stands for Scandinavian Total Ankle Replacement. Stryker divested the STAR ankle to DJO Global in November 2020 as part of its move to acquire Wright Medical. The FDA alert points out, based on its analysis of post-approval studies and adverse event reports, that the risk of fracture applies to all STAR ankle devices regardless of manufacture or distribution date.

Need to For An Additional Surgery

But, the FDA does note that the implant remains appropriate for certain patient populations such as older patients with lower activity levels. Those with more active lifestyles, people who have osteoarthritis and those under the age of 55, may face a higher risk of the plastic component breaking.

The FDA says patients who are considering a STAR ankle implant should discuss all treatment options for a painful arthritic joint with healthcare providers so they can make an informed decision. Some of the symptoms of trouble with this implant include new worsening pain, inability to bear weight, new grinding or other noise or instability in the ankle implant. Healthcare providers may need to get X-rays or even CT scans to evaluate the issue.

The FDA’s study shows that the plastic component in these implants fractured at a cumulative rate of 13.8% at eight-year post-implantation, with all fractures requiring additional surgery. In fact, breaks were observed as early as three to four years after implantation. Since 2009, the FDA has received at least 1,841 adverse event reports for STAR ankle. About 300 of the reports cited fractured plastic components.

Medical Devices and Product Liability

Medical device manufacturers have a duty and an obligation to make devices that are safe for consumer use. When they make defective devices, consumers who receive those devices are not only put in extreme danger but may also need to surgically extract the device from their bodies. This leads to additional pain and suffering, and costs associated with surgery, hospitalization, and so on.

Injured victims of defective medical devices can seek compensation by filing a product liability lawsuit against the manufacturer. They may be able to seek damages such as medical expenses, loss of wages, hospitalization, permanent injuries, disabilities, pain and suffering and emotional distress. An experienced product defect lawyer will be able to advise them regarding their legal rights and options.

Source: https://www.fda.gov/medical-devices/safety-communications/risk-device-component-breaking-patients-strykers-star-ankle-fda-safety-communication

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