Metal-on-Metal Orthopedic Devices Linked to Complications
"Metal-on-metal" (MoM) is a term typically used to describe hip implant systems made of all-metal components, though it may also be used to describe some all-metal knee implant systems as well. These devices have been subject to national controversy for the past decade because of reports of complications like premature loosening, high failure rates, and metal toxicity and poisoning.
DePuy Orthopaedics and Zimmer, Inc. have been most visible in the debate concerning MoM implants, with DePuy implementing a metal-on-metal orthopedic device recall in August 2010. Zimmer temporarily suspended sales of its MoM Durom Cup in 2008, which has sometimes been mistakenly referred to as another metal-on-metal orthopedic device recall.
Other companies have also had to defend themselves against a metal-on-metal orthopedic device lawsuit. As time goes by, more and more patients seek the advice of a metal-on-metal orthopedic device lawyer, as they intend to hold large medical companies liable for failing to ensure the safety of their products.
Zimmer Halts Sales of the Durom Cup
The FDA approved the Zimmer Durom Cup, a MoM device, in 2006, but it was only a year later that prominent orthopedic surgeon Dr. Larry Dorr reported his concerns to the company. In 2008, the doctor wrote a letter to his colleagues at the American Association of Hip and Knee Surgeons, noting the high failure rates he was seeing with the Durom Cup.
Zimmer implemented a temporary suspension of sales in 2008, but re-issued the device when a company investigation concluded the problems were due to surgical error, not the design of the implant. Meanwhile, thousands of plaintiffs filed lawsuits, claiming premature loosening, pain, instability, and metal toxicity. In 2010, Zimmer set aside millions for a metal-on-metal orthopedic hip device lawsuit settlement fund. All federal cases have now been centralized in New Jersey.
Zimmer is also battling allegations for its Zimmer NexGen knee implants. These all-metal devices have not been linked to metal toxicity, but have been reported to fail earlier than other knee implants, prompting a barrage of lawsuits. All federal Zimmer NexGen knee cases have been centralized in Illinois.
DePuy Implements Metal-on-Metal Orthopedic Device Recall
Whereas Zimmer never recalled the Durom Cup, DePuy implemented a metal-on-metal orthopedic device recall in August 2010. After hundreds of reports of problems allegedly related to the all-metal design of the DePuy ASR hip implant, the company withdrew the product from Australia in 2009, but waited until the following year to recall it in the U.S.
A metal-on-metal orthopedic device lawyer is likely to argue that the company was aware of the complications with its product long before the recall, and should have done more to alert physicians and the public to the dangers. When DePuy did recall the ASR in 2010, they admitted to a 13 percent failure rate.
Problems stemmed from the metal ball of the implant rubbing against the metal cup in the hip socket, an action that can deposit tiny shards of cobalt and chromium into neighboring tissues, the hip joint, and even into the bloodstream. Such metal toxicity can cause inflammation, tissue death, bone damage, and other related symptoms that can hasten implant failure.
FDA Shows Concern, Studies Indicate High Failure Rates
In May 2011, the FDA announced that it was requiring 21 manufacturers of MoM hip implants to conduct additional post marketing surveillance studies to further determine the safety of their products. The agency followed up with an announcement in March 2012 that it was seeking expert scientific and clinical advice on the risks and benefits of MoM systems.
Meanwhile, a March 2012 study published in The Lancet concluded that MoM implants, particularly those with larger diameter head surfaces, failed at a higher rate than implants with ceramic or polyethylene components. The authors stated, "Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted."
Plaintiffs File Lawsuits Against Biomet, Wright, and Smith & Nephew
As concern about MoM devices grows, more plaintiffs are coming forward to file a metal-on-metal orthopedic device lawsuit. Many have recently complained of problems with the Biomet M2A-Magnum all-metal device, which has been linked with similar complications as the Zimmer Durom Cup and DePuy ASR. Reports submitted to the FDA of problems linked with the M2A increased from 11 in 2009 to 80 in 2011, with complaints including metal toxicity, chronic pain, bone loss, and popping or squeaking noises.
Wright Medical Technology, Inc., is also defending its implants in court. The Wright Conserve family of MoM hip implants has recently been linked to complications like metal poisoning and premature loosening. In September 2011, the National Joint Registry for England and Wales reported that revision rates for the Wright Conserve devices were significantly higher than other implants reviewed, with rates for the Wright Conserve Plus second only to the devices manufactured by DePuy. Federal Wright Conserve lawsuits were recently consolidated in Georgia for pre-trial proceedings.
Wright also manufacturers the Wright Profemur MoM implant, which was linked to an unacceptably high failure rate of 11.2 percent by the Australian National Joint Replacement Registry in 2009.
Smith & Nephew, as well, has faced allegations against its R3 Acetabular MoM hip implant system. On June 1, 2012, the company implemented a metal-on-metal orthopedic device recall, withdrawing the metal liner for the R3 because of less-than-satisfactory clinical results. Patients implanted with the R3 were more likely to require revision surgery than those implanted with combination material implants.
Filing a Metal-on-Metal Orthopedic Device Lawsuit
Millions of dollars have already been paid to plaintiffs in a number of metal-on-metal orthopedic hip device lawsuits. If you or a loved one has suffered complications from the Zimmer, DePuy, Biomet, Wright, or Smith & Nephew orthopedic device, a metal-on-metal orthopedic device lawyer at Chaffin Luhana LLP may be able to help. Call today for a free and confidential case evaluation at 1-888-480-1123.