Metal-on-Metal Hip Replacement Component Recalled by Smith & NephewJun 5, 2012 | Parker Waichman LLP
Medical device maker Smith & Nephew has pulled a component of an all-metal hip implant off the market because patients with it face a higher-than-average risk of suffering complications caused by it.
According to a report from Reuters, Smith & Nephew has pulled a metal cup that’s used with its R3 Acetabular System hip implant. The metal cup, not the entire system, is being recalled. Surgeons will be able to use a non-metal cup and still use the R3 system for implants.
The company estimates that at least 7,700 people worldwide have been implanted with a metal cup on the R3 system, a metal-on-metal hip replacement system. As many as 1.6 percent of patients with the metal cup have been forced to endure a revision surgery within a year of receiving it. Most common among the complications that lead to these surgeries are infections, fractures, and dislocations of the joint. There have not been any reported cases of toxic metals building up in a recipient’s bloodstream linked to use of the metal cup in the R3 implant system.
That defect, alone, has prompted many recipients of various types of all-metal hip implants to consider having their implant replaced entirely after enduring several revision surgeries. All-metal hip implants, in general, have been linked to myriad health problems, including those that have prompted Smith & Nephew to take action on its R3 cup component. The risk of toxic metals cobalt and chromium accumulating in a recipient’s bloodstream can lead to metallosis, organ and tissue damage, and possible organ failure. The metal accumulations in hip implant recipients have also been linked to other side effects, such as tinnitus, vertigo, deafness, blindness, optic nerve atrophy, convulsions, headaches, peripheral neuropathy, cardiomyopathy, and hypothyroidism.
That led to the 2010 recall of the DePuy Orthopaedics ASR hip implant system after an unusually large number of recipients experienced problems consistent with all-metal hip implants, including a risk of metallosis. More than 90,000 people have received that implant and many are now considering having it removed long before they had ever imagined. Early failure rates have been estimated anywhere between 13 and 30 percent for that specific implant. The 1.6 percent failure rate of the R3 metal cup component with the Smith & Nephew device is higher than the 1 percent tolerated by England’s National Institute for Health and Clinical Excellence for new devices.
Metal hip implants and metal hip implant components were pitched to prospective recipients mainly because they were supposed to last longer and be more durable than traditional ceramic or plastic components. In many cases, they were marketed more toward younger recipients.