The Smith and Nephew hip recall of June 2012 affected approximately 7,700 individuals who received the optional metal liner component of the British manufacturer’s R3 Acetabular System. Introduced to the market in 2007 and globally launched in 2009, most of the recalled liners were used in stemmed total hip replacements. In speaking to the reasons for its recall, Smith & Nephew denies there to be evidence that the liner used in the metal hip replacement system causes metallosis (metal ion poisoning), but did admit that patients who received the device have reported:
- Fractures; and
While the company does acknowledge these complications, officials do not take responsibility for their cause. However, Dr. Andy Weymann, Smith & Nephew’s Chief Medical Officer, has urged anyone who has experienced adverse reactions after receiving the device to see a doctor as soon as possible. “As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon,” he said.
Reasons for the Smith and Nephew Hip Recall
Further, the company issued the following statement on the day of the Smith and Nephew hip recall regarding the R3 Acetabular System’s effectiveness:
“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component.” This statement was issued in response to clinical testing results that indicated there to be a 1.6 percent annual revision rate in patients who received the R3 Acetabular System. This number is well above the 1 percent rate considered normal by Britain’s National Institute for Health and Clinical Evidence.
The R3 Acetabular System also had a higher than normal revision rate over four years than considered normal. Since it was globally launched in 2009, the device experienced a 6.3 percent revision rate. The average for total hip replacements is only 2.89 percent.
On the date of the recall, which was issued after more reports of early failure rates began to surface, Smith & Nephew said the metal liner was not “performing as well” as the manufacturer expected.
The manufacturer now markets its R3 system with a plastic, metal or ceramic cup and a liner made with OXINIUM or cross-linked polyethylene (XLPE) plastic.
Considering a Smith & Nephew Hip Lawsuit? Contact Us Today.
If you were received the optional metal liner component of Smith & Nephew’s R3 Acetabular System before it was recalled in June 2012, you may be eligible to receive compensation for medical bills, lost wages, as well as any pain or suffering you may have been caused. Find out more about your legal options by calling a lawyer at Bernstein Liebhard LLP at (888) 727-7285.