The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the polyethylene component of Stryker’s STAR ankle replacement device is prone to breaking “as early as three to four years after implantation,” potentially necessitating surgery to repair or replace the device.

The FDA’s warning is based on the agency’s review of post-approval studies and adverse event reports. Based on its review, the FDA is warning that the risk of failure may be present in all Stryker STAR ankle replacement devices—regardless of when they were manufactured or surgically implanted.

FDA: Risk of Stryker STAR Device Failure is Higher for More-Active Patients

The FDA notes that the risk of failure is higher for more-active patients. While the FDA states that Stryker’s STAR ankle replacement device, “remains appropriate for certain populations, such as older patients with lower activity levels,” it also states that the higher than expected risk impacts a broad range of patients. Specifically, FDA’s review of post-approval studies and adverse event reports found that the following populations face a high risk of device failure:

• Patients with more-active lifestyles
• Patients with osteoarthritis
• Patients younger than 55 years of age

Given the high risk of device failure for patients in these populations, the FDA is encouraging anyone seeking care for ankle arthritis to discuss all options with their healthcare providers. For patients who currently have Stryker STAR ankle replacement devices, the FDA recommends:

• Talk to your healthcare provider if you experience worsening pain, instability or noise in your ankle, or if you are unable to weight your foot.
• Tell your doctor if you have concerns about your Stryker STAR ankle replacement device, as a CT scan may be necessary to determine whether your device is broken.
• Report any concerns regarding your Stryker STAR ankle replacement device to the FDA using it’s MedWatch Voluntary Reporting Form.

What is the FDA Doing in Response to Its Concerns Regarding the Stryker STAR Ankle Replacement Device?

At this point, the FDA is continuing to review post-approval studies and adverse event reports, and it is working with Stryker to identify potential mitigation measures and update the company’s product labeling. It is not currently taking regulatory enforcement action against Stryker.

What are Your Legal Rights if Your Stryker STAR Ankle Replacement Device Fails?

While the FDA is not currently pursuing claims against Stryker, if your STAR ankle replacement device has failed, you may have a claim against the company based on the law of product liability. Companies have an obligation to ensure that their products are safe for their intended use, and companies that sell defective products can – and should – be held liable. 

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