On March 15, 2021, the U.S. Food and Drug Administration announced that all Scandinavian Total Ankle Replacement (STAR) devices might fail prematurely, no matter when they were made or distributed. This warning updates previous warnings that only included devices made before 2014.
The STAR Ankle is one of the most implanted ankle devices in the United States. However, the FDA warns that post-market surveillance and adverse events reports show that it fails at a higher than expected rate. The watchdog agency reports that a plastic component in the device may sometimes break as soon as 3 or 4 years after implantation, forcing patients to undergo risky revision surgery.
If you or a loved one received a STAR Ankle replacement device that failed, and you had to have revision surgery to have the device removed or replaced, you may be entitled to significant financial compensation. Contact us now to learn more about your rights and whether you may qualify.
About the STAR Ankle Replacement Device Failure
The STAR Ankle system was first developed in 1978 and remains the only cementless, mobile-bearing ankle device on the U.S. market. And while the device was marketed as having a high success rate at ten years past implementation, the FDA has found that all STAR Ankle devices have a plastic component that can fail, sometimes as soon as a few years after being implanted.
Patients who were implanted with the STAR Ankle system are alleging the manufacturer knew or should have known that the device can break but failed to warn the medical community or its patients about fracture risk. Our attorneys are investigating claims on behalf of any patient who received this device and then had to undergo revision surgery to have the broken device removed or replaced.
STAR Ankle Failure Reports
The FDA reports it has received about 1850 adverse event reports since 2009 and that about 300 of those events involved devices that had fractured. Manufacturer data also showed that out of 244 implanted devices removed from patients, 72 were fractured. Worth noting is that the agency found material oxidation degradation and mechanical property loss on devices that had only been implanted for a few years. It also highlighted that exploratory surgery was required in two cases to find the fractures, so the failure rate may be higher.
FDA Tells Physicians to Weigh the Pros and Cons of Device
The FDA continues to work to determine the cause of the failure. In the meantime, the agency reports that while the device may work in older, less active adults, a higher risk of device failure may be seen in patients who:
- are under the age of 55, or
- have osteoarthritis, or
- live active lifestyles.
FDA Recommendations for Patients Who Already Have the Device
If you or someone you love has been implanted with the STAR ankle, the FDA recommends that you speak with your physician if you:
- experience instability, or
- suffer new or increasing pain at the implant site, or
- are unable to put weight on the ankle, or
- feel or hear grinding or other noises from the device.
Patients who experience problems with the device may undergo a physical examination, and X-rays may be taken to evaluate the ankle. Because fracture in the device can be quite subtle, a CT scan may be required. The FDA is investigating the cause of the failure, and the agency encourages patients who experience problems to report the issues via the MedWatch Voluntary Reporting Form.
We Can Help
We have been fighting for patients’ rights for decades, and we stand ready to fight for you now. If you or a loved one received the STAR Ankle and were forced to undergo revision surgery due to device failure, contact us today. You may be entitled to significant financial compensation. Contact us now to learn more about your rights and whether you qualify.