Stryker Ankle Implant Break

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Stryker Ankle Implant Break

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Stryker® Ankle Replacement Failure

The FDA has reported that some plastic Stryker ankle replacement implants have a high risk for breaking. According to studies and real-world monitoring, younger patients who pursue higher levels of activity may have an unexpectedly higher risk of fracture of the device. Although alterations to the Stryker device have been made to better protect the pieces from degradation, the increased level of activity of the patient may cause the device to fail more rapidly. Younger and more active patients are simply having an ankle implant break more often. These Stryker ankle implants appear to be more appropriate for older patients with lower activity lifestyles.

“At this time, we are not recommending removal of any implants,” said Capt. Raquel Peat, director of the FDA’s Office of Orthopedic Devices. “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.”

The STAR ankle device stands for “Scandinavian Total Ankle Replacement”. Made for arthritis sufferers, this device was one of the first flexible implants of its kind. But, since 2009, the FDA has received at least 1,841 adverse event reports on the STAR ankle. A break in the plastic part of the implant has been seen as early as three to four years after the implant insertion.

One long-term study found a failure rate of 13.8% over eight years. Many of these artificial ankle implants were inserted before the 2014 packaging change for the STAR ankle implant. However, there are documented ankle implant failures AFTER the 2014 change. The study also found that among 72 fractured devices that were completely removed by surgery, plastic breaks were less common in implants with thicker plastic. Nevertheless, most implants showed signs of material wear within three to four years post-implant.

If you are 55 years of age or younger, have had a Stryker ankle replacement, are experiencing pain, and have had additional surgery to repair the implant, you may potentially have a claim against the company.

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