FDA Warns of Significant Defect with STAR Ankle Implant

April 22, 2021

If you or a loved one had ankle replacement surgery and doctors used a Scandinavian Total Ankle Replacement (STAR) device, it could break or fail much sooner than expected.

On March 15, the U.S. Food and Drug Administration (FDA) notified patients and health care providers about a plastic component that may fail within just three or four years of implantation. If the device breaks, you may need surgery to repair or replace it.

The FDA’s analysis of the long-term post approval study found the risk may apply to all STAR ankle devices, no matter when they were made or distributed.

There have been 300 adverse event reports about broken plastic components since 2009. These involved STAR Ankle implants made before and after 2014, which is when the manufacturer made changes meant to slow the breakdown of the plastic component.

The FDA also looked at data on 244 implants that were removed. The data showed 72 plastic components had broken. The thinner components were more likely to break compared to the thicker components. There was only one fracture in the thickest plastic pieces.

For the most part, there was material oxidation degradation three to four years after the device was implanted. There was also loss of mechanical properties.

What if You Have the Implant or are Considering it?

Despite the risks, the FDA’s safety communication said the implant may still be appropriate for some older people with low activity levels. Patients who are more active, suffer from osteoarthritis or are below 55 years of age may be at risk of having the device break.

If your doctor is considering using the STAR Ankle implant, the FDA is recommending you discuss other options. For those who already have one of these implants, the FDA recommends the following steps:

• Alert your health care provider if you experience: new pain that is getting worse, trouble putting weight on the ankle, grinding noises or instability.
• You may need a CT scan to determine if the plastic component is intact or broken.
• You are encouraged to report problems to the FDA using the MedWatch Voluntary Reporting Form.

What is the FDA going to do?

The FDA plans to work with Stryker (the manufacturer) to get a better understanding of why the plastic component is failing. The FDA will also review medical literature, post approval studies, adverse event reports, and accounts from patients, doctors and orthopedic professional societies.

The FDA safety communication also said the administration will work with Stryker to make sure patients and other interested parties are notified about the risks. The FDA is also looking to identify ways to mitigate the risk and modify product labeling to ensure people are adequately informed about the danger.

Background on STAR Ankle Implants

STAR Ankle implants may be used to replace arthritic ankle joints caused by osteoarthritis, rheumatoid arthritis or post-traumatic arthritis. The device is made of a tibial plate, mobile-bearing polyethylene component and talar component. The device is meant to allow for some amount of normal function and mobility in the ankle.

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