According to U.K. regulators, Stryker Corp.'s uncemented Accolade Femoral Stems have been associated with a high failure rate when used in combination with DePuy Orthopaedic's Mitch TRH Cup/Heads in total hip replacement procedures.
New York, New York (PRWEB) April 04, 2012
Parker Waichman LLP, a national law firm representing victims of defective hip implants and other medical devices, is warning metal-on-metal hip implant patients that Stryker Corp.'s uncemented Accolade Femoral Stems have been associated with a high failure rate when used in combination with DePuy Orthopaedic's Mitch TRH Cup/Heads in total hip replacement procedures. According to an April 2 advisory issued by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), data from the England and Wales National Joint Registry indicated that the revision rate for patients with this type of metal-on-metal total hip replacement was 10.7 percent four years after implantation. [mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con149604.pdf]
According to Parker Waichman LLP, it is thought that 271 people in England and Wales have this combination of hip components. Both symptomatic and asymptomatic patients are to be monitored on an annual basis, with additional investigations to be carried out in those experiencing symptoms, the MHRA said.
This new warning comes a little more than a month after the MHRA advised that patients with large diameter metal-on-metal hip joints (bearings greater than 36mm) should have annual blood tests and possibly MRI scans for the lifespan of the joint. [mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON143782]
About Metal-on-Metal Hip Implants
Parker Waichman LLP is already representing scores of plaintiffs in personal injury lawsuits filed against the makers of all-metal hip implants, including DePuy Orthopaedics's recalled ASR Acetabular Hip Implant System, as well as a metal-on-metal version of the DePuy Pinnacle Acetabular Cup System. Lawsuits involving the ASR hip implant have been consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio (MDL 2197). Meanwhile, DePuy Pinnacle hip implant lawsuits have been consolidated in a multidistrict litigation in U.S. District Court for the Northern District of Texas (MDL 2244).
The ASR hip implants were recalled from the global market in August 2010. However, the all-metal Pinnacle hip implant and many other metal-on-metal hip replacements remain on the market. In February, an investigative report in the British Medical Journal warned that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic and potentially cancer-causing metals from failing metal-on-metal hip implants. A large study published last month in The Lancet showed that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years, prompting the authors of the study to call for an end to their use. [bmj.com/content/344/bmj.e1539/rr/571634; thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext]
In May 2011, the U .S. Food & Drug (FDA) directed 21 companies that market all-metal hip replacements, including DePuy and Stryker, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. Last week, the agency announced its Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip systems, as well as potential patient and practitioner recommendations for their use. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm; fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297745.htm]
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved experienced premature failure of your implant or other health problems associated with metal-on-metal hip replacement devices, please contact their office by visiting the firm's defective hip implant page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP
Herbert Waichman, Partner