July 9, 2012 — Stryker Corp. announced a voluntary recall of two hip implants: the Rejuvenate Modular and ABG II modular-neck hip stems. The company is concerned that the implants are prone to fretting and/or corrosion, which can shed toxic metal debris into the spaces surrounding the joint. People with hip implant corrosion may suffer chronic pain, swelling, and failure of the hip implant, necessitating an additional surgical repair of the device.
In a press release, Stuart Simpson, vice president and general manager of hip reconstruction, had this to say:
“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 an corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action.”
Company officials encouraged patients with the hip implants to contact their surgeon immediately. They have already notified healthcare professionals and government regulatory agencies of their decision. Furthermore, the company will terminate global production of the devices.
This is Stryker’s second metal-on-metal hip replacement recall this year. In April, Stryker recalled the Accolade femoral stem used with the MITCH TRH modular head/acetabular cup. Post-marketing surveillance found very high rates of revision associated with the devices.
Metal-on-metal hip implants have come under increasing regulatory scrutiny in recent months. Two weeks ago, in response to nearly 17,000 adverse event reports, the FDA conducted a 2-day meeting to discuss safety issues with the devices. Experts concluded that there was little reason to choose the metal-on-metal design over plastic and ceramic devices. Metal-on-metal hip implants have been linked to a five-year failure rate of 6% — three times higher than plastic or ceramic devices. One study published earlier this year also linked the devices to higher rates of corrosion compared to plastic or ceramic devices.
Most of the side effects occur because the metal parts of the device grind together when the patient moves. This can cause tiny particles of cobalt and chromium to shed into surrounding tissues. In severe cases, metal ions can leak into the bloodstream and cause life-threatening metal poisoning.
The FDA has asked 31 different manufacturers of these devices, including Stryker, to conduct long-term safety studies. However, it may take up to a decade before these studies are complete.