March 15, 2021
The following quote is attributed to Capt. Raquel Peat, Ph.D., M.P.H., USPHS, director of the Office of Orthopedic Devices in FDA's Center for Devices and Radiological Health:
“After reviewing long-term data from an FDA-required post-approval study, published literature, real-world evidence and adverse event reports, we’re taking action to advise patients, their caregivers and health care providers of the higher than expected rate of fractures—or breakage—of a plastic component in the Scandinavian Total Ankle Replacement, or STAR Ankle device. This potential risk of plastic component fracture has been found to occur as early as three to four years after implantation. When compared with other total ankle replacement devices, the higher fracture rate and earlier than expected occurrence of fracture are concerning.
At this time, we are not recommending removal of any implants. While the risk of fracture of the device is higher than expected, the device remains appropriate for certain patients, such as older patients with lower activity levels. Those who have had ankle replacement surgery with the STAR Ankle should follow their surgeon’s recommendations for follow-up visits and consult with their surgeon if they experience symptoms such as new or worsening pain or instability.
Protecting the public health is our mission and we’ll continue to work with the device’s manufacturer, Stryker, to better understand the factors that have contributed to the plastic component fracture, ensure patients and medical providers are aware of the potential risks, and identify ways to mitigate that risk."
- Today, the US Food and Drug Administration issued a safety communication providing important recommendations for patients who have or are considering STAR Ankle replacement—a non-cemented device for total replacement of a painful arthritic ankle joint as a result of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis—and their caregivers, as well as information for health care providers who treat and follow patients with a STAR Ankle device.
- Over the past several years, the FDA has raised concerns with the device manufacturer, Stryker, about the high fracture rate of the plastic component in the STAR Ankle device that was first found during review of a required post-approval study. After a 2014 packaging change made by the manufacturer to address the problem, independent analysis by the FDA shows that the potential for plastic component fracture to occur may exist for all STAR Ankle devices regardless of the manufacture date or packaging, and as early as three to four years after implantation.
- Results from a long-term, eight-year, FDA-required post-approval study showed that 13.8% of devices had a plastic component fracture at eight years post-implantation. The FDA reviewed postmarket data from over 1,800 medical device reports dating from 2009 (when the device was approved) to December 2020 related to STAR Ankle, as well as data provided separately by the manufacturer that showed 72 out of 244 removed STAR Ankle devices had plastic component fractures.
- While the long-term fracture rate is not yet known in devices manufactured after the 2014 packaging change, all patients who have the device implanted or are considering getting the device should be aware of the potential risk of plastic component fracture, which may subsequently require re-operation.
- Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect or experience a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.