Smith & Nephew, one of the world’s largest medical device manufacturers, recently issued an urgent recall for a metal component of its R3 Acetabular Hip System after it had been linked to a number of serious complications. According to the recall announcement, side effects associated with the Smith & Nephew replacement hip include bone fractures, infections, and a life-threatening condition known as metallosis.
Smith & Nephew Hip Implant Complications
When it first hit the market, Smith & Nephew advertised the optional metal liner of its R3 Acetabular System as durable and wear-resistant. However, instead of long-lasting durability, the devices have been reported to fail at an alarming rate, and have been linked to the following hip replacement complications:
- difficulty walking
- squeaky joints
- faulty components
- plant contamination
- local tissue damage
- high failure rates
Hip Replacements & Metallosis
Many of the problems related to the Smith & Nephew R3 Acetabular System may be the result of its metal-on-metal design. The metal liner of the device is made of cobalt and chromium, and studies have shown that the release of these elements into the bloodstream can lead to a life-threatening condition known as metallosis. Complications arising from metallosis have been reported to include:
- tissue damage
- inflammatory reactions
- bone loss
- genetic damage
- aseptic fibrosis
- local necrosis
In October 2010, the American Academy of Orthopedic Surgeons (AAOS) issued a warning about the risk of metallosis from metal hip implants like the Smith & Nephew R3 Acetabular System. The warning indicated that doctors and patients should be aware that complications such as extreme pain months after surgery could be a sign of metal poisoning.
Smith & Nephew Hip Replacement Recall
On June 1, 2012, Smith & Nephew announced a worldwide recall for the metal liner of its R3 Acetabular System after numerous reports of loosening, pain, device failure, infection, metal sensitivity, and dislocation. Recipients of the device were forced to undergo revision surgery at a rate of 6.3% in four years compared to the average of 2.89% for primary total hip replacements. In its recall announcement, Smith & Nephew stated that the metal liner of the R3 Acetabular System was not ‘performing as well’ as the company had expected, and that it was ‘not satisfied with the clinical results.’
If you suffered one or more of the complications listed in this article after being implanted with a Smith & Nephew R3 Acetabular Hip, you may be eligible to be compensated for revision surgery costs, as well as any pain and suffering you incurred as a result of your injuries. Recipients of Smith & Nephew replacement hips are encouraged to evaluate their legal options even if they’re not experiencing complications, since metal ions in the blood may not always manifest themselves as symptoms in the early stages.