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. Then, it issued a recall of its Modular SMF and Modular Redapt Revision Femoral Hip System in 2016.
Smith & Nephew is a London-based medical device manufacturer that manufactures several lines of joint replacement systems for hips, knees and shoulders. According to the company’s annual revenue report, its hip implants brought in $163 million in 2015. But, recalls and lawsuits took a share of the profits.
In 2012, Smith & Nephew issued a voluntary recall for the metal liner in one of its hip implant devices, the R3 Acetabular System. Then, in 2016, the company issued recalls for the Modular SMF Hip and Modular Redapt Revision Femoral Hip Systems.
R3 Acetabular System Recall
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.”
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.
Modular SMF and Modular Redapt Revision Femoral System Recall
Smith & Nephew originally marketed the Modular SMF Hip Stem as the MIS Hip Stem when it first hit the market in the U.S. in 2008, according to the company’s 510k premarket notification. The Redapt Revision Femoral System hit the U.S. market in 2012, also through the 510k process.
On November 15, 2016, Smith & Nephew issued a voluntary recall for both the SMF and Redapt because of “a higher than anticipated complaint and adverse event trend,” according to the company’s Urgent Field Safety Notice. The recall affects devices shipped from October 2008 to July 2016.
The device maker said it would these implants and any related modular neck components from the market.
Smith & Nephew says the risk to patients could include adverse events linked to metal debris released by the implant that could lead to revision surgery. The company recommends doctors monitor their patients for high levels of metal ions in the blood — levels above 7 parts per billion (ppb). This equals 119 nmol/L cobalt or 132.5 nmol/L chromium.
Complications and Problems with Recalled Hips
Complications and problems relating to the Smith & Nephew Hips may be a result of their metal-on-metal design. Numerous studies and FDA safety communications warned about the possible complications of these types of implants.
The metal liner of the R3 Acetabular is made of cobalt and chromium. The SMF and Redapt have titanium coatings and use cobalt-chromium neck stems. 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.
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. Smith & Nephew hip lawyers are investigating new claims with the SMF and Redapt Hip Systems.
According to Smith & Nephew’s 2015 financial reports, it set aside $203 million “for known, anticipated and settled metal on metal hip claims and associated legal expenses of $21 million.”
Patients who received these recalled devices 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.