FDA Warns of Breaks in Stryker Ankle Replacement Devices
On March 15, 2021, the FDA issued a warning with respect to Stryker’s STAR Ankle. According to the warning letter, the STAR (Scandinavian Total Ankle Replacement) devices have a plastic component that may break as soon as three to four years after the STAR Ankle is surgically implanted. Should the component break, the patient may suffer significant pain and require surgery to replace or repair the device.
The STAR Ankle is an artificial ankle used to replace a painful arthritic ankle joint in patients suffering from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. The STAR Ankle is intended to increase mobility and provide an alternative treatment option to those patients whose ankle joints cause persistent pain. While the STAR Ankle was initially approved in 2009, the FDA required that Stryker conduct studies to examine the device’s safety and effectiveness.
Results from the post-approval studies revealed a higher break rate in STAR Ankles when compared with other comparable total ankle replacement devices. Indeed, by the eight-year mark of the study, the break rate of the plastic component in the STAR Ankle was 13.8 percent. All breaks required surgical intervention. In addition to breaking more frequently, STAR Ankles may break earlier than anticipated. In the FDA-required studies, breaks were observed as early as three to four years after implantation. In response to the study results, the FDA issued a warning of the STAR Ankle’s break risk to patients who have or are considering the device and their caregivers.
If you or a loved one has needed surgery to replace a Stryker STAR Ankle breaking, contact Burg Simpson’s medical device attorneys in Cincinnati today. Our Cincinnati product liability lawyers know what it takes to fight for their clients and get results – even against the biggest companies in the world. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.