Smith & Nephew Hip Replacement
Smith & Nephew hip replacement lawsuits filed over the recalled metal liner component of the company’s R3 Acetabular System seek compensation for medical expenses, lost wages, pain and suffering and other damages incurred by the patient’s injury. To find out more about your legal rights, contact an attorney at Bernstein Liebhard LLP by calling (877) 779-1414.
Smith and Nephew Hip Replacement Recall
On June 1, 2012, Smith & Nephew recalled the optional metal liner component of its R3 Acetabular System after company data revealed a high frequency of complications suggested to stem from the device. Introduced in 2007 after being approved by the U.S. Food and Drug Administration (FDA), the recall of this Smith & Nephew hip replacement affected approximately 7,700 individuals. Many of these patients received this metal liner as part of stemmed total hip replacements.
On the date of the recall, Smith & Nephew listed the following complications associated with the metal liner component of its R3 Acetabular System:
The company claims it has not found evidence that exposure to the metal liner may lead to metallosis (metal ion poisoning) caused by heightened levels of metal debris. Clinical testing did however reveal that annual revision rates in patients implanted with the Smith and Nephew hip replacement were 1.6 percent—well above the 1 percent rate deemed acceptable by Britain’s National Institute for Health and Clinical Evidence.
Despite the fact that metallosis is not listed as a complication associated with the Smith & Nephew hip replacement recall, this side effect has been named in lawsuits involving the device. One plaintiff who filed a claim over Smith & Nephew’s R3 system in November 2012 alleges the hip replacement caused him to suffer metallosis and other injuries.
In his lawsuit, the patient suggests this may be due in part to the fact that Smith & Nephew received approval for the device via the U.S. Food and Drug Administration (FDA)’s 510(k) process, which does not require a product to undergo rigorous clinical testing if its maker can prove it to be equivalent to one already on the market.
“Had Defendants conducted clinical trials of the R3 system with a metal liner before it was first released, they would have discovered at that time what they ultimately learned — that the R3 System with a metal liner results in a high percentage of patients developing metallosis, biologic toxicity, and an early and high failure rate due to the release of metal particles in the patient’s surrounding tissue when the metal femoral head rotates within the metal acetabular liner,” states the claim filed on November 27th, 2012.
After being filed in Sacramento County Superior Court that December, this Smith & Nephew hip replacement lawsuit has since been transferred to the U.S. District Court for the Eastern District of California as per a removal of action by the manufacturer.
Early failure rates resulting in revision surgeries have been suggested to stem from other metal hips as well. Right now, approximately 3,800 lawsuits have been filed over the version of the DePuy Pinnacle hip replacement that includes a metal Ultamet liner, while court records indicate almost 11,000 claims have been brought on behalf of patients who received the DePuy ASR metal-on-metal hip replacement.
Many of these lawsuits are pending in federal multidistrict litigations (MDL) in courts in the U.S.
How to File a Smith Nephew Hip Replacement Lawsuit
If you experienced complications after being implanted with the optional metal liner component of the Smith & Nephew R3 Acetabular System, you may be eligible to file a claim against the British manufacturer of all-metal artificial hip systems. Contact an attorney at Bernstein Liebhard LLP to find out more about your legal rights at (877) 779-1414.