Product News and Recalls

Safety Notice Issued for Birmingham Hip Resurfacing System

birmingham hip replacement system likely to cause revision surgerySmith & Nephew has issued an urgent field safety notice updating the instructions for use of its Birmingham Hip Resurfacing System. The notice reveals that certain groups of patients are more likely to require revision surgery after receiving a Birmingham Hip Resurfacing System implant. These groups include females, men aged 65 or older, and patients who require an implant head equal to or smaller than 48mm. The field safety notice specifically applies the Resurfacing Head, Acetabular Cup, and Dysplasia Cup components of the Birmingham Hip Resurfacing System.

Smith & Nephew, a UK-based medical device manufacturer with U.S. headquarters in Memphis, TN, has recently come under fire for its Birmingham Hip Resurfacing System, which was introduced to the market back in 2006. Hip resurfacing is an alternative surgical solution to total hip replacement; instead of replacing the entire worn-down femur with a prosthetic one, a metal cap is placed over the existing bone along with a matching metal socket, which is inserted in the acetabulum, or pelvic socket. This way, only a few centimeters of the original bone is removed, allowing patients to retain more of their bone structure. Hip resurfacing can also reduce the risk of hip dislocation and facilitate future replacement or revision surgery if either turns out to be necessary.

smith and nephew makes the birmingham hip resurfacing systemDespite its promise, however, numerous recipients of the Birmingham Hip Replacement System have reported serious pain or injury associated with failure of the device. Due to its metal-on-metal design, when components of the implants rub against one another, various metallic ions, such as cobalt and chromium, are released into the bloodstream. These can build up in the soft tissue of the body and cause metallosis. Metallosis has been associated with extreme pain, dizziness, and fatigue, and can lead to loosening or dislocation of the implant, which requires revision surgery. It is a health problem found among several metal-on-metal hip implants, such as those produced by DePuy, Stryker, and Zimmer.

Smith & Nephew has also run into trouble with its total hip replacement devices. In June 2012, the company recalled the optional metal liner component of its R3 Acetabular System due to high rates of failure. The R3 metal liner, which is inserted into the device’s metal pelvic socket, was originally designed for use with the Birmingham Hip Resurfacing System. According to the U.S. Food and Drug Administration, the R3 Acetabular System was never cleared for use with the R3 metal liner. Plaintiffs in Smith & Nephew hip replacement lawsuits claim that the combination of these devices caused fracturing, dislocation of the implant, and infection of the tissue around the hip joint.

Check with your doctor of physician whenever you seek to change treatment plans. If you or someone close to you suffered from a failed Smith & Nephew hip resurfacing or replacement implant, contact the lawyers at Lopez McHugh immediately to receive a free consultation. You may be eligible to receive compensation through a Smith & Nephew resurfacing or replacement lawsuit.