DePuy Synthes Radial Head Prosthesis System

The DePuy Synthes Radial Head Prosthesis System is an implant device that replaces elbow joints. In 2016, the device’s manufacturer, DePuy, recalled over 50,000 implants because a stem attached to the device was prone to loosening. When that stem loosens, patients are at risk of suffering serious side effects including fractures, bone tissue loss, and severe discomfort.

The device consists of two parts. One part is a synthetic head—the knobby end to one of your forearm bones—which replaces the natural radial head. The second part is a stem that is implanted into the radius—the bone to which the synthetic head is attached. The device is designed to restore joint function where a patient has suffered an elbow fracture that can’t be repaired, has worn down their elbow joint over time, or suffers from certain degenerative diseases, such as arthritis.

In 2016, patient began having issues with the device, reporting complications from a loosened stem. DePuy could not immediately determine why the device had malfunctioned in some patients, but continued to market the device for revision surgeries that only required replacement of the head component.

However, in late 2016, Johnson & Johnson issued a voluntary recall of the device. The states reason for the recall was that the component implanting the device into the radius bone could detach, causing destruction of bone tissue, pain, fracture and joint problems. The FDA reported 40 instances of the loosening failure, and subsequently labeled the company’s action a Class 2 Device Recall which involves a product that may cause “a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.”

If you or a loved one has suffered complications from a DePuy Synthes Radial Head Prosthesis System, you may be entitled to compensation. Contact the experienced lawyers at Neumann Law Group for a free consultation.