On December 29, 2016, DePuy issued a recall for over 50,000 elbow joint replacement devices known as the “DePuy Synthes Radial Head Prosthesis System.” The company reported that the device’s radial stem, which attaches the device to the lower arm, may loosen after surgery. If loosening occurs the device may not function properly and can lead to other health problems such as, loss of bone tissue, post-operative bone fractures, soft tissue damage, and pain. As a result, on February 2, 2017, the U.S. Food and Drug Administration (FDA) classified the recall as a Class 2 device recall. The FDA classifies a recall as a Class 2 when the product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
The Synthes Radial Head Prosthesis System was allowed on the market through the 510(k) clearance program in June 2011 for use in various elbow replacement surgeries. The 510(K) clearance program does not require a device to undergo human clinical trials prior to coming to market, so long as a manufacturer can prove that the product is substantially equivalent in design to a device that had previously received FDA approval.
DePuy has instructed medical professionals to return all unused affected products as soon as possible. For the patients who have already been treated with the recalled product, DePuy instructs health professionals to follow these patients in the usual manner.
If you or a loved one suffered injuries that you believe were caused by a DePuy Synthes Radial Head Prosthesis System contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today