FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices | Searcy Denney Scarola Barnhart & Shipley
To embed, copy and paste the code into your website or blog: The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the polyethylene component of Stryker’s STAR ankle replacement device is prone to breaking “as early as three to four years after implantation,” potentially necessitating surgery to repair or replace the device. The FDA’s warning is based on the agency’s review of post-approval studies and adverse event ...
Source: jdsupra.com