U.K. company Smith & Nephew designed a range of metal-on-metal hip implant systems as a means to provide relief for patients in need of hip replacement surgery. The R3 Acetabular System, one of these metal-on-metal systems, first hit the U.S. market in 2009 and quickly turned into a sensation with over 7,700 devices implanted worldwide.
However, the system’s metal liner experienced a far higher than normal failure rate, leading to patients’ need to undergo painful revision surgeries. Reports showed the R3 hip system experienced a 6.3% failure rate in four years, significantly higher than the average 2.89% for primary total hip replacements. Smith & Nephew issued a worldwide hip implant recall for the R3’s metal liner in 2012. Below, we review the claims brought against Smith & Nephew over the R3 hip implant system and complications caused by the recalled R3 metal liner.
Smith & Nephew released the R3 Acetabular System in 2009 as a replacement for a hip’s ball and socket components. The company states they designed the R3 Acetabular System to enhance hip stability and allow surgeons more device options.
The U.K. manufacturer categorizes the R3 system as a modular hip implant, meaning it contains interchangeable parts. These interchangeable parts consist of a femoral head (made of either the company’s OXINIUM Oxidized Zirconium, cobalt chrome, or Biolox ceramic) and a liner (made of OXINIUM or cross-linked polyethylene (XLPE) plastic). When paired with a metal liner, the R3 system turns into a metal-on-metal hip implant system. The R3’s metal liner, specifically, was marketed as a durable and wear-resistant component in the R3 system.
Smith & Nephew designed the R3 system for use in total hip replacement and hip revision surgeries, using the design to relieve diagnoses such as noninflammatory degenerative joint disease (NIDJD), osteoarthritis, and avascular necrosis, among others.
In 2012 Smith & Nephew recalled the metal liner used in the R3 Acetabular hip system after reports indicated that the liner caused an increased risk of bone fracture, device dislocation, and infection, among other injuries. While this was a voluntary recall, Smith & Nephew stated the R3’s metal liner was not “performing as well” as the company expected and had a high failure rate due to the liner’s design.
The R3’s metal liner is made of cobalt and chromium like the BHR hip implant system. However, cobalt-chromium implants reportedly release metal ions into the body due to the constant grinding of metal on metal. Metal ions in the bloodstream can cause metal sensitivity in patients and a type of metal poisoning known as metallosis. Metallosis has been found to cause a number of painful side effects like infection, tinnitus, and headaches.
Additionally, the constant grinding of metal R3 liner on the rest of the metal R3 system can cause bone and muscle deterioration, implant loosening, and device failure, resulting in the need for patients to need a revision surgery to fix. Other metal-on-metal implants comparable to the R3 system experienced similar complications, raising concerns that R3 Acetabular System recipients could be at a high risk of injury.
U.S. Federal law completely restricts the sale of the R3 hip systems due to the high failure risk. Approximately 7,700 R3 devices have been implanted worldwide since its release in 2009, so thousands could be at risk of injury from the deceptively marketed liner.
The majority of R3 metal liner lawsuits were settled in 2015, but thousands of individuals may still be at risk of injury from their R3 metal liner. Smith & Nephew has faced hundreds of lawsuits over their other metal-on-metal hip implant systems, raising questions about the integrity of their manufacturing and whether they place profits before public health.
If you believe your R3 hip implant may be failing and causing your pain & suffering, reach out to us today. We offer free, no-obligation case evaluations to see if you may be the victim of a defective Smith & Nephew hip implant. At the McGartland Law Firm, our award-winning attorneys fight for your right to compensation for your injuries, and we don’t back down from tackling legal giants to do so. When you partner with our personal injury firm, you partner with decades of integrity and efficiency. Reach out to us today at (866) 832-9300.