Monday, June 4, 2012

Smith & Nephew Withdraws Metal Liner used in Hip Replacement From Market


DO YOU HAVE A DEFECTIVE METAL-ON-METAL HIP REPLACEMENT?

Another metal-on-metal hip implant component has been withdrawn from the market due to poor clinical results. DePuy Orthopaedics recalled the ASR XL metal-on-metal hip in August 2010 due to higher than expected failure rates and patients reporting cobalt toxicity issues.

Business Week reports that Smith & Nephew PLC, a London based medical device company, announced on Friday (June 1, 2012), that it is voluntarily withdrawing a metal liner used in its R3 Acetabular Metal-on-Metal hip replacement system. This metal liner was introduced in 2009 and approximately 7,700 of the devices have been implanted. 



The company stated that it pulled the optional metal liner from the hip replacement system because it was "not satisfied with the clinical results" of the liner, and some patients needed an additional surgery to have the liner removed.  The clinical results showed "1.6% of patients with this system needed revision surgery each year, which is above the 1% guideline set by Britain's National Institute for Health and Clinical Excellence."  Patients needing hip replacement surgery will be offered the traditional plastic liner instead of the metal-on-metal configuration.

New hip
(Photo credit: okadots)

Smith & Nephew says the issues with the metal liner in the R3 Acetabular hip system are different than those seen in other all metal implants such as the recalled DePuy ASR hip. Smith & Nephew contends patients with this metal liner experienced problems including infections, fractures and dislocations, but no reports causing "metallosis" or the build up of other metallic debris in the body. Smith & Nephew claims the voluntary withdrawal of this device is a precautionary move and that patients who already have the device implanted are at low risk and do not need to have it removed. 


Metal-on-Metal hip implants generally have been linked to high rates of revision surgery and systemic complications because of component erosion and leaching of metal ions both locally and into blood circulation. In 2010, DePuy Orthopaedics issued a recall of its ASR metal-on-metal hip due to early failure rates. Problems surrounding the ASR device include increased blood levels of cobalt and chromium ions, intense hip, thigh, and groin pain, a loss in overall mobility, component misalignment and loosening,  and possible tissue and bone necrosis.

CONTACT US TODAY!

If you or someone you know suffered pain and/or had to undergo additional surgery as a result of having a metal-on-metal hip replacement, contact attorneys Jon Mann or Chris Hellums at 1-866-515-8880 so we may evaluate your potential claim. You may be entitled to financial compensation.  Don’t delay, you don't want to let your statute of limitations expire.
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