Styker Corporation’s Rejuvenate and ABG II modular-necks are used in hip implants. These two systems include several neck and stem components to help patients receive an implant that’s more custom-fitted for their needs.
In June 2008, the FDA approved Stryker’s Rejuvenate system, and the ABG II system received FDA approval in November 2009. Both systems were approved through the FDA’s 510(k) Premarket Notification Process, which allows a drug or medical device to be offered to the public without having to undergo clinical trials. The drug or product, however, must be substantially similar to a product that has already received FDA approval.
Stryker necks are made of chromium and cobalt, and the stems are coated with titanium. The product has a metal-on-metal junction that can lead to health problems as the implants wear. In 2011, the FDA instructed producers of metal-on-metal hip implants to conduct studies of patients who received the devices to determine whether the implants are shedding high levels of metallic debris.
Lawsuits Against Stryker
In April 2012, Stryker issued an Urgent Field Safety Notice for Corrective Action for its Rejuvenate Modular Stems and Necks. The company noted that there were potential risks associated with fretting and corrosion at the modular neck junction. Deterioration or corrosion at this junction may lead to an increased metal ion generation in the surrounding joint space and can potentially cause damage to bone and/or soft tissue surrounding the implant and joint. This is referred to as an “adverse local tissue reaction” (ALTR). Complications that may result from ALTR include:
- Implant loosening
- Device failure
- Need for revision surgery
Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems in June 2012 due to the systems’ potential for fretting and corrosion. As of July 2012, there were 45 reports of adverse events from patients who say the devices caused pain and/or tissue swelling.
The FDA also issued a warning letter to Stryker in the fall of 2007 noting that the company failed to take steps needed to prevent squeaking and other problems in ceramic hip replacements. During 2007, Stryker also recalled ceramic hip parts made at its factory in Cork, Ireland, after determining that some did not meets sterility specifications.