DePuy has recalled its elbow joint replacement device known as the “DePuy Synthes Radial Head Prosthesis System.” The Radial Head Prosthesis is a medical device used to replace the head of the radius bone if it is fractured or broken. The radius bone is the shorter of the two bones of the forearm, with the head of the bone ending at the elbow joint. Most injuries to the radial head occur when falling on an outstretched arm. If the head of the radius bone is fractured or broken in such a manner that it cannot heal, the medical device replaces the radial head in an effort to restore the joint function to the arm and elbow. The device consists of a head, which replaces the natural head of the radius bone, and a stem, which fits down into the canal of the radius bone.
DePuy recalled its Radial Head device after receiving reports of the device becoming loose after implantation. According to a 2017 article published in the Journal of Orthopaedic Trauma, the Synthes radial head device loosened more frequently and to a greater degree than another manufacturer’s radial head device. The loosening occurs in the device stem which is inserted in the canal of the radius bone. Loosening of the radial head medical device often results in pain, discomfort, bone loss, soft tissue damage, and lack of mobility and/or function. Often times, pain in the forearm area can be an indication of a loose radial prosthesis stem. If the pain or lack of function is great enough, the patient may be required to undergo a revision surgery to remove or replace the device.
If you or a loved one suffered injuries you believe were caused by a DePuy Synthes Radial Head Prosthesis, contact the nationally recognized medical device attorneys in Burg Simpson’s Cincinnati, Ohio office today. They can be reached by phone at (513) 852-5600 or through their website.