Earlier this summer, medical device maker Stryker Corp. issued a recall on its Rejuvenate modular neck hip implant component because it was prone to defects that could result in serious injuries for people who had it implanted.
In July, Stryker recalled the hip implant component because it was prone to corrosion and fretting that put recipients at risk of serious injuries, including many of the same injuries that recipients of defective metal-on-metal hip implants. The Rejuvenate device is not a metal-on-metal implant but is a component part of a hip implant that also uses ceramic and plastic parts. Rejuvenate was marketed as an alternative to metal-on-metal hip implants and designed with a younger recipient in mind.
In addition to the risks of fretting and corrosion that will cause pain and inflammation at the site of the Rejuvenate implant component, people who’ve already reported problems after being fitted with the device have also reported high metallic rates in their blood. Metallosis, or metal poisoning, is caused by a toxic accumulation of metallic ions. When a person receives a Rejuvenate hip device, some of its metal-on-metal components are prone to distribute small fragments of cobalt and chromium into a recipient’s bloodstream.
When a person experiences complications caused by their Rejuvenate hip implant device, they’re bound to have revision surgeries to correct problems it may be causing and eventually will have to be fitted with an entirely new device. Among many Rejuvenate recipients, thousands potentially, an early failure will prompt these avoidable surgeries much sooner than the devices were designed to last.
The recall of the Rejuvenate device comes at a time when federal health officials are investigating the myriad reports from recipients of metal-on-metal and other faulty hip implant devices that detail complications and injuries suffered as a result of their defects. The investigation was deemed necessary following the 2010 recall of a metal-on-metal hip implant, the DePuy Orthopaedics ASR hip implant. Thousands of recipients had come forward detailing their injuries and how they’d been forced to undergo revision and replacement surgeries after suffering some of the same injuries facing recipients of the Rejuvenate device.
The FDA is requiring manufacturers of hip implants, including Stryker Corp., to conduct post-market research on the products they manufacture and the agency will use this information to determine the future of metal-on-metal hip implants and products like Rejuvenate that rely on that and other technology. Many of these devices were hurried to the market through the FDA’s own “fast-track” approval system.
Recipients of the Rejuvenate device will also mirror recipients of other faulty hip implants and begin to seek damages for the injuries and unexpected medical costs they’ve incurred as a result of the product’s defects. Several recipients of the defective device have already filed lawsuits against Stryker over Rejuvenate defects.