The Stryker hip replacement recall was announced in July 2012, and affected as many as 20,000 Rejuvenate and ABG II Modular-Neck Hip Stem sold throughout the world. The metal hip components were pulled from the market after data indicated they were vulnerable to fretting and corrosion at the modular neck junction. This action can release dangerous amounts of toxic metal ions into a recipient’s tissue and blood stream, leading to a number of serious complications, including:
By July 2014, the Stryker hip recall had prompted some 3,700 people to file lawsuits seeking compensation for painful and debilitating complications related to Rejuvenate and ABG II hip stems. Among other things, plaintiffs in the claims allege that Stryker failed to subject the components to enough testing to ensure their safety and effectiveness.
The Rejuvenate and ABG II hip stem systems involved in the Stryker hip replacement recall consist of necks manufactured of chromium and cobalt, while the stems are coated with titanium. The Rejuvenate system utilized six stems and 16 necks that could be used interchangeably to create a custom fit for each patient. The ABG II system had eight right stems, eight left stems, and ten modular necks.
Stryker touted these hip systems as the “next generation” and “latest evolution” in hip replacement technology. They were supposed to offer greater stability, less bone stress, and a better range of motion than traditional hip implants.
Unfortunately, neither of these hip systems was subjected to human clinical trials before they came to market. Instead, they were approved via the U.S. Food & Drug Administrations (FDA) 510(k) clearance program, which doesn’t require such trials if a device is shown to be “substantially equivalent” to a product already on the market. As such, the problems with the devices did not become known until they were implanted in tens of thousands of people around the world.
The first warning that something might be wrong with the Rejuvenate and ABG II hip stems came in April 2012, when Stryker issued an urgent notice to doctors and hospitals warning that recipients of the components faced a risk of “excessive metal debris and/or ion generation.” The actual recall was announced that July. By that time, some 20,000 Rejuvenate and ABG II hip stems had been sold worldwide, though it’s not known how many may have been implanted in patients.
In January 2013, Stryker advised all patients fitted with recalled Rejuvenate and ABG II hip stems to undergo medical imaging and blood testing to ensure the integrity of their components. According to the company, it had determined that the absence of symptoms did not necessarily mean that the hip stems were performing as intended.
Since July 2012, thousands of people affected by the Stryker hip replacement recall have filed lawsuits seeking compensation for their injuries and complications. Because a large number of such filings were expected, two consolidated litigations were established to handle the claims. One of those is underway in New Jersey’s Bergen County Superior Court, where more than 2,000 lawsuits had been filed as of July 2014. Another, in the U.S. District Court, District of Minnesota, is overseeing more than 1,600 claims.