Orthopedic device manufacturer Stryker Orthopaedics has 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.
“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” said Stuart Simpson, Stryker’s vice president and general manager of hip reconstruction, in a statement.
The company said that it chose to recall the devices after continued post-market surveillance data, suggesting there have been a number of complaints associated with the devices.
The move echoes a large 2010 recall of two all-metal hip devices made by Johnson & Johnson subsidiary DePuy Orthopaedics: the ASR XL Acetabular System and the ASR Hip Resurfacing System. DePuy recalled the devices after medical data revealed they were failing prematurely at a high rate, and linked to problems including dislocation, fracture, inflammation, pain, and in some cases serious complications related to metal poisoning. Much of the controversy surrounding metal-on-metal hip implants stems from their potential to release metal particles into the body, which can become ionized and lead to numerous complications.
In March, a the authors of study funded by the National Joint Registry of England and Wales, whose hip implant data prompted the DePuy recall, called on orthopedic surgeons to stop using all brands of metal-on-metal hip implants completely. The researchers analyzed data concerning more than 400,000 hip replacements made in the U.K. from 2003 to 2011 and found that patients with metal-on-metal hip implants experienced hip implant failure and other complications at a rate three times higher than patients who received conventional hip devices made with ceramic or plastic components.
In the newly recalled Stryker implant, the hip socket joint itself is not a metal-on-metal joint. However, the femoral stem and the femoral head ball connection is metal-on-metal.