In June, medical technology corporation Smith & Nephew announced it is recalling its R3 Acetabular System, an optional metal liner component usually used in conjunction with stemmed total hip implants.
This latest recall adds to growing fears over the high rate of premature failure associated with artificial hip implants made with metal-on-metal components and the speed at which many of these devices were rushed to market.
“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” Andy Weymann MD, Smith & Nephew’s Chief Medical Officer said in a statement about the R3 Acetabular recall. “As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon.”
Smith & Nephew says about 7,700 of the metal R3 Acetabular liners have been implanted since it introduced the component in 2007.
U.S. Food and Drug Administration (FDA) officials opened a two-day session June 27 to address concerns over metal-on-metal hip devices. A large worldwide recall in August 2010 of two all-metal hip devices made by Johnson & Johnson subsidiary DePuy Orthopaedics triggered widespread worries that the devices, which were designed to be more durable than their ceramic and plastic counterparts, were actually failing prematurely and harming many patients.
DePuy’s recalled ASR implants are now the subject of litigation in the U.S., Canada, U.K., Australia, New Zealand, and other countries. About 93,000 of the devices were implanted in patients worldwide, including some 37,000 in the U.S.
Most recently, Stryker Orthopaedics recalled two of its hip implant models over concerns the devices are prone to “fretting and corrosion” that could trigger pain, swelling, and other complications in patients. The recall involves Stryker’s Rejuvenate Modular and ABG II modular-neck stem devices, devices that incorporate a femoral stem and femoral head ball connection that are both made of metal. Stryker advises patients who have been implanted with one of the recalled devices to contact their physician. Meanwhile, the company has stopped global production of the devices.
More than half a million Americans have been implanted with some form of metal-on-metal hip device, medical experts estimate. Most of these patients received their metal hip implants between 2003 and 2010. Nearly 17,000 complications blaming metal hip implants have been reported to the FDA. Seventy-six percent of the reports were filed in 2011 alone.
Patients who have had a metal-on-metal hip implant or implant component such as Smith & Nephew’s R3 Acetabular system may be at risk of injuries associated with metal poisoning, a result of friction between the device’s all-metal parts releasing metal particles into the bloodstream and surrounding tissue. Other problems associated with metal hip implants often include inflammation, chronic pain, infection, device failure, and complications that could require patients to undergo painful revision surgery.