This is part one of a two-part article regarding specific issues of Stryker’s recalled ABG II and Rejuvenate hip implant devices. Stryker’s ABG II and Rejuvenate, once believed to be the greatest innovations in hip implant devices, were voluntarily recalled in July of 2012. Both implants are constructed with a modular-neck hip stem and were brought into the extremely competitive hip implant market in 2009. Unlike “typical” metal-on-metal hip implants, the new Stryker design allowed surgeons to have a wider variety of parts to choose from, ensuring each patient was custom-fitted with the best length and angle for their specific size and activity level.
The Rejuvenate and ABG II hip devices have four parts rather than the usual two—the femoral stem, a metal neck, a ball and an acetabular cup. Although the ball of the Rejuvenate and ABG II is made from ceramic rather than metal—ostensibly providing a much safer device than the all-metal implants—after some 53,000 of the implants were marketed, Stryker’s models were found to have many of the same issues. The metal neck juncture as well as the metal trunnions located on the neck piece resulted in many Stryker patients submitting adverse reports to the FDA after suffering pain, inflammation and symptoms of metal toxicity.
In an attempt to minimize the fear factor once Stryker realized a recall was in the works the company sent out an urgent safety notice to hospitals and physicians two months before the official recall. At that time Stryker warned of the potential of the Rejuvenate and ABG II to suffer fretting, corrosion and early failure. Just as the all-metal hip implants were found to release cobalt and chromium ions into surrounding tissues and the bloodstream, Stryker’s models also release those metal shards following corrosion of the metal parts. Recipients of the Stryker ABGII and Rejuvenate have reported chronic and severe pain, uneven wear or breaking of the implant, fractures and broken bones, difficulty walking and signs of metal poisoning.
Metal shards which lodge into the hip tissues can lead to inflammation, tissue necrosis and bone loss, while those entering the bloodstream can lead to cardiovascular, neurological, renal, thyroid and gastrointestinal problems as well as vision and hearing loss, vertigo, DNA disruption, the formation of pseudotumors, anxiety, depression and irritability. Although the lifespan of the Rejuvenate and ABG II implants was expected to be anywhere from 10-20 years—considerably longer than ceramic and polyethylene implants—however many patients are requiring revision surgery after only one to four years.
While the metal-on-metal implants were supposed to extend the lifespan of the implant even longer than fifteen years, unfortunately they have not performed as expected and are experiencing extremely early failures. As you can imagine, many surgeons across the United States have been forced to have very difficult conversations with patients who were not only told their implant would last a decade or more but that it was perfectly safe. Even those patients who have not yet experienced any adverse health effects from their Stryker Rejuvenate or ABG II should know that the likelihood of implant failure is much higher than the 12% stated by Stryker during the recall.
Since the Rejuvenate gained FDA approval in 2008 and the ABGII in 2009, it is clear that patients have not had these implants in their bodies any longer than five years, yet a large number of those patients have already suffered complications and have been forced to undergo revision surgery. Despite the risks associated with revision surgery as well as complexities of the procedure itself, patients need their hip to function in order to go about their day-to-day life, therefore have little choice in the matter once they experience adverse symptoms. For more information regarding revision surgery and the options available to Rejuvenate and ABG II patients, please see part two of this article.