Several years ago, the medical device company DuPuy Synthes issued a recall of over 50,000 elbow-joint replacement devices. The device, referred to as a radial head prosthesis system, is a two-piece elbow joint replacement implant that received clearance from the Food and Drug Administration (FDA) in 2011. The recall was issued after complaints arose that the device could loosen over time, resulting in serious injury.
Details on the Elbow Implant Recall
In a recall letter sent to healthcare providers, DePuy notes that complications may arise after the joint replacement device is implanted during surgery. Specifically, the radial stem piece of the implant may loosen over time. This could result in severe injuries and medical complications. According to Depuy, if the radial stem loosens, the risks include:
- Elbow inflammation and swelling
- Bone fractures
- Bone loss
- Poor joint movement
- Pain and discomfort
- Soft tissue damage
Once the implant loosens, surgery may be needed to repair or replace the device entirely. DuPuy officials state that health administrators should continue to follow patients with an elbow-joint replacement device with their usual manner.
Background on DuPuy’s Elbow-Joint Replacement Device
DePuy Synthes did not have to complete comprehensive clinical trials to test the safety of its radial head prosthesis system before it was distributed to healthcare providers because it expedited approval by going through the FDA’s 510 (k) approval process. Products are approved through the FDA’s 510(k) when the agency determines the proposed device is equivalent to an existing previously approved device currently in use.
DePuy contested that its radial head prosthesis system had the equivalent use, principal characteristics, and similar materials as devices like the Biomet ExploRTM (K051385) and Ascension (K032686) modular radial head devices already in use. The FDA agreed with DuPuy and granted the device the 510(k) approval. This allowed the device to be issued to patients without undergoing the strict approval process outlined by the FDA.
How an Attorney Can Help
If you or a loved one received a DePuy elbow-joint replacement device and experienced elbow pain, bone loss, or other side-effects, you may be entitled to compensation. The knowledgeable product liability attorneys at The Whitley Law Firm can review your case and help you navigate your claim. To speak to an experienced member of our team, contact us today.