FDA Orders Metal-on-Metal Hip Implant Surveillance Studies
As more Zimmer hip lawsuits are filed and concerns about the safety of all metal-on-metal hip replacements grow, the FDA has ordered all manufacturers of the devices to conduct post marketing surveillance studies. The FDA issued 145 orders on May 6, 2011 to 21 manufacturers, including Zimmer Holdings, Inc. the manufacturer of the Durom Acetabular Component system or “Durom Cup”.
The Zimmer Durom Cup device was approved for marketing in the US in 2006 and temporarily withdrawn by the company in 2008 because of allegations that an unexpected number of individuals were suffering premature Zimmer hip failure. As a result, Zimmer hip lawsuits have been filed in both state and federal courts throughout the US.
FDA order addresses Zimmer hip problems, metallosis
Under the new FDA order, metal-on-metal hip manufacturers will have to monitor patients to evaluate whether these implants are causing metallosis or metal poisoning; a condition characterized by high levels of metallic debris in patients. The concern is that the metal particles seep into surrounding tissue or the bloodstream resulting in chronic pain, premature hip failure, and the need for hip revision surgery. Metallosis may cause other damage to organ systems resulting in pain, ahortness of breath, numbness, weakness and other symptoms.
Zimmer Durom Cup: metal-on-metal design
Most metal-on-metal hips are designed with the ball (femoral head) and socket (acetabular cup) components made from cobalt and chromium metals. The Durom Cup has a monoblock design, meaning the femoral head (ball) fits inside a one piece metal acetabular cup, and is composed of a cobalt chromium alloy with a pure titanium plasma sprayed coating for fixation.
Until recently, metal-on-metal devices accounted for about one-third of the estimated 250,000 hip replacement procedures occurring in the US. Over the past two years however, use of these devices has declined as reports of Zimmer hip failure and serious health problems related to the metallic particles shed by the devices has grown.
FDA requirements for Zimmer hip and other metal-on-metal hip manufacturers
Under the new FDA plan, metal-on-metal hip manufacturers are required to submit research protocol to the agency and have 30 days to file their proposed plan. The companies must collect information for device recipients including blood samples measuring the level of metallic ions in their systems and determine the frequency of their devices failing requiring the patient to undergo a revision surgery.
According to a New York Times report Dr. William H. Maisel, the deputy director for science at the F.D.A.’s Center for Devices and Radiological Health, said that this group of studies is the largest the FDA has ever asked from an approved class of devices.
FDA requirements and Zimmer hip lawsuit settlements
The FDA mandate could have an impact on current Zimmer hip lawsuits, many of which have been ordered to mediation as part of the Multidistrict Litigation (MDL) taking place in the District of New Jersey. The new requirements could prompt more generous Zimmer hip lawsuit settlements in an effort for the company to sidestep the order. On the other hand, the FDA action could cause Zimmer hip lawyers to reject those offers and take their chances on better outcome in court.
The Initial Scheduling Order filed with the court on May 3, 2011 currently reflects eight Zimmer hip lawsuits. If the mediations do not yield any Zimmer hip settlements, the cases will proceed to discovery and possibly, trial. The next Zimmer hip lawsuit status conference is scheduled for June 29, 2011.