Weitz & Luxenberg is now accepting cases of patients who are experiencing complications or needed revision surgery because of the DePuy Synthes’ Radial Head Prosthesis system, an implant used to replace part of the elbow joint.
The DePuy Synthes Radial Head Prosthesis is a two-piece modular system comprised of a titanium alloy stem and cobalt chrome head. The device was approved by the U.S. Food and Drug Administration (FDA) in June 2012 for primary and revision radial head replacement surgeries.
In December 2016, the DePuy Synthes Radial Head Prosthesis system was recalled due to the possibility of loosening of the device post-operatively, specifically the radial stem at the stem-bone interface.
Recall of the DePuy Synthes Radial Head Prosthesis System
In December 2016, DePuy Synthes issued an Urgent Notice Medical Device Field Safety Notification announcing product removal for its Radial Head Prosthesis System because of the possibility of the stem component loosening at the stem-bone interface. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database includes dozens of reports of loosening and revision due to loosening with the Radial Head Prosthesis System.
The recall was designated Class II by the FDA. As a part of the recall, DePuy instructed health care practitioners to review their inventories and quarantine and return any affected products.
Complications with the DePuy Synthes Radial Head Prosthesis System
Per DePuy Synthes’ Medical Device Field Safety Notification regarding the Radial Head Prosthesis System, complications in patients with this implant who experience device loosening may suffer from pain, poor joint mechanics, osteolysis, post-operative bone fracture, and soft tissue damage and irritation.
Some patients may require or have already had revision surgery to correct complications from the implant.
W&L Can Help Patients Harmed by the Synthes Radial Head Prosthesis System
Weitz & Luxenberg’s Drug & Medical Device Litigation Unit Practice Group Co-Chair Ellen Relkin says the firm is interested in hearing from anyone who underwent radial head replacement elbow surgery using the DePuy Synthes Radial Head Prosthesis System and is now suffering complications such as pain or limited range of motion, or had or has been informed they need to have revision surgery because of the device.
You may be entitled to compensation for medical expenses, lost wages, and other costs. An experienced attorney can help you explore your options.
Ms. Relkin has played a lead role in several major medical device litigations, including helping to secure a $2.5 billion settlement for patients harmed by defective DePuy ASR hip implants and a $1 billion resolution over recalled Stryker Rejuvenate and ABG II hip implants.
Weitz & Luxenberg is ready to assist you, beginning with a free consultation. Contact us at (855) 524-0488 or by using the online form on this page to discuss your legal options.