The U.S. Food and Drug Administration has issued a risk communication regarding all Scandinavian Total Ankle Replacement devices (STAR Ankle). According to the FDA’s report, there is a higher-than-expected risk of the polyethylene (plastic) component of STAR Ankle device breaking, leading to surgery to repair or replace the device. Fractures of the plastic component of the STAR Ankle may occur as early as three to four years after implantation. The FDA’s report is based on a study of FDA-required post approval studies and adverse event reports.
The FDA provides the following recommendations for health care providers who treat and follow patients with a STAR Ankle:
- Review the FDA’s recommendations for patients who have or are considering the STAR Ankle, and caregivers listed on the FDA website. Also review these recommendations with your patients.
- “As part of shared decision-making, discuss the benefits and risks of all relevant treatment options for painful arthritic ankle joints with your patients.
- Read and carefully follow the Instructions for Use for the STAR Ankle.
- Surgeons should closely monitor patients with the STAR Ankle for potential fractures of the plastic component of the device.
- If surgeons suspect a fractured plastic component (for example, there is pain or noise from the device), consider performing X-rays to further evaluate the device integrity. Changes on X-rays can be subtle; if X-rays are negative and a polyethylene fracture is still suspected, a CT scan may be needed to determine whether a plastic component fracture has occurred. Be aware that the clinical presentation (the presence of signs or symptoms) of fracture in plastic materials such as polyethylene can be subtle even in a CT scan and, infrequently, may be diagnosed only on exploratory surgery.
- Thinner (6mm) plastic components appear to be more prone to fracture.
- Younger patients (under 55 years old) and patients with a primary diagnosis of osteoarthritis may have higher risk of plastic component fracture and subsequent revision surgery.”
The FDA encourages health care professionals and patients who suspect or experience a problem with the STAR Ankle device to file a report through the MedWatch Voluntary Reporting Form.
If you suspect a STAR Ankle device has malfunctioned or contributed to a serious injury or adverse outcome, the FDA also encourages filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care professionals employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions, please email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
For additional details on the study, including reporting responsibilities for hospitals and facilities, a more detailed description of the device, the study findings, and the FDA’s continuing actions regarding this device, please see the FDA safety communication.
Risk of device component breaking in patients with Stryker’s STAR Ankle: FDA Safety Communication. U.S. Food and Drug Administration. March 15, 2021. Available at https://www.fda.gov/medical-devices/safety-communications/risk-device-component-breaking-patients-strykers-star-ankle-fda-safety-communication. Accessed March 17, 2021.