Smith & Nephew initiated a worldwide recall of the metal liner in its R3 Acetabular System in 2012, after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation. Almost 4,000 of the metal liners were used in the United States between 2009 and the recall.
Smith & Nephew is a London-based medical device manufacturer that manufactures several lines of joint replacement systems for hips, knees and shoulders. The company is the fourth largest manufacturer of hip implants in the United States, with a 12.1 percent market share and $313 million sales in 2010. It has also had its share of defective devices and hip implant recalls, however. In 2012, Smith & Nephew issued a voluntary recall for the metal liner in one of its hip implant devices, the R3 Acetabular System.
The R3 Acetabular System was released in Europe and Australia in 2007, and in 2009 the hip replacement system was launched in the United States. Smith & Nephew Orthopedics initiated a worldwide recall of the metal liner in its R3 Acetabular System on June 1, 2012, after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation. About 7,700 R3 devices have been implanted worldwide since 2009. The device experienced a higher than normal revision rate — 6.3 percent in four years compared with the average of 2.89 percent for primary total hip replacements. In the recall, Smith & Nephew stated that the metal liner was not “performing as well” as the company expected and that it was “not satisfied with the clinical results.”
Complications and Problems with the R3 Acetabular System
Complications and problems relating to the metal liner of the R3 Acetabular System may be the result of its MoM design. The metal liner is made of cobalt and chromium. Cobalt-chromium implants have been shown to release ions into the body, and studies have revealed that chromium and cobalt ions are carcinogens linked to blood poisoning and genotoxicity (DNA damage). The ions can cause local tissue reactions that destroy muscle and bone and spread to other organs. Cobalt has also been linked to cardiomyopathy, or heart muscle disease. The deterioration of bone and muscle around the implant can lead to loosening and device failure. All of these complications have been known to lead to metallosis, which is also known as metal poisoning.
After the recall, the Smith & Nephew sent out “hazard alert” letters to doctors who had implanted the metal liners, claiming that the recall was a “precautionary step.” Smith & Nephew also said it was unable to identify one single reason for the device failure, but there were reports of “infection, dislocation, metal sensitivity, loosening/lysis and fracture.”The letter further instructed doctors to follow up with their patients if they had received the liner.
While there have been no recalls for the OXINIUM ceramic liner of the R3 Acetabular System, the U. S. Food and Drug Administration (FDA) issued a warning in December 2010 to Smith & Nephew for this component. Specifically, Smith & Nephew did not follow protocol in documenting manufacturing procedures, including sterilization of the product and machine settings used to manufacture the titanium rings in various ceramic inserts. The FDA also noted that batches of the products did not meet minimum sterilization requirements. The FDA concluded that these practices and others were “not in conformity with the Current Good Manufacturing Practice (CGMP) requirements.”
Smith & Nephew Lawsuits
Almost 4,000 of the R3 Acetabular metal liners were used in the United States between 2009 and the June 1, 2012, recall. Because of its metal liner, people who received this implant have suffered a number of complications. Studies have already shown that a high number of R3 Acetabular Systems with the metal liner failed prematurely and required revision surgery.
Patients who received this recalled device may have legal options against Smith & Nephew to receive compensation for revision surgery costs incurred and any pain suffered. Recipients of the metal liner option in this device are encouraged to evaluate their legal options even if they’re not experiencing complications, since metal ions in the blood may not always manifest symptoms in the early stages.