The recall is being initiated because post-marketing surveillance found high rates of fretting corrosion (a type of corrosion that occurs when two non-lubricated, compressed metal surfaces grind together).
When a hip implant begins corroding, the person may suffer severe pain and swelling in the hip. They may require surgery to replace the hip with a new device.
Stuart Simpson, Stryker’s general manager of hip reconstruction and vice president, published a press release with this statement:
“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.” Stryker will cease global production of the Rejuvenate Modular and ABG II modular-neck hip implants.
The press release announced that Stryker has already sent notifications to healthcare professionals. Company officials are advising patients with hip implants to check with their doctor regarding the Stryker hip implant recall.
Stryker previously recalled another metal-on-metal hip replacement this April. The Accolade femoral stem used with the MITCH TRH modular head or acetabular cup was recalled after the company’s post-marketing surveillance linked the device to a high revision rate.
Two weeks ago, an FDA panel convened to discuss what to do about metal-on-metal hip implants. Several studies were published this year linking the devices to higher rates of side effects compared to plastic or ceramic devices. The FDA experts found little reason to choose a metal-on-metal device. One study found that 6% of metal-on-metal hip implants fail within five-years — three times higher than plastic and ceramic hip implants. Another study this year found that metal-on-metal hip implants corrode more quickly and severely than plastic or ceramic devices.
Most of the problems with metal-on-metal hip implants occur because the metal head and cup grind together under pressure and without lubrication. Over time, tiny particles of chromium and cobalt can corrode from the device and leak into nearby tissues. This increases the risk of toxic metal poisoning.
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