Stryker Hip Stem Information
Stryker Corporation, a Fortune 500 company valued at more than $20 billion, markets more than 57,000 products around the world. In 2012, the Kalamazoo, Michigan-based, medical device maker generated more than $8 billion in sales. Unlike many of its competitors, including Johnson & Johnson, which announced the DePuy ASR hip recall in 2012, Stryker does not make metal-on-metal hip implants. As a result, the company was able to remain largely untouched by the controversy surrounding these devices. In fact, as the issues involving metal-on-metal hips grew, Stryker’s market share actually increased.
In July 2012, however, Stryker found itself embroiled in its own hip implant controversy involving the Rejuvenate and ABG II Modular-Neck Hip Stem systems. Launched on the market in 2009, the Rejuvenate and ABG II stems were touted as innovations in artificial hip technology. But both Stryker hip stems were recalled in July 2012, after postmarket data indicated they were causing problems in an unexpectedly high number of patients. Now, a growing number of Stryker hip lawsuits have been filed in courts throughout the country on behalf of individuals who suffered debilitating complications, allegedly due to the Rejuvenate and ABG II stems.
Stryker Hip Replacements
The Stryker Rejuvenate and ABG II hip systems are different from most artificial hips, in that they consist of several modular necks and stem components. This design is intended to give surgeons more flexibility by allowing a doctor to pick and choose from the necks and stem components to create a custom-fit for each particular patient. Stryker’s ABG II system offers 16 stems – eight each for the left and right hips – and 10 modular necks. According to Stryker, these components offer greater stability and minimal bone stress. The Rejuvenate system was touted as a longer-lasting hip that would allow a greater range of motion. This Stryker hip replacement system consisted of six stems and 16 necks, and was marketed to younger patients.
Both of these Stryker hip replacements were manufactured with a proprietary titanium alloy that consisted of titanium, molybdenum, zirconium and iron. Stryker promised that this metal blend would be resistant to the effects of fretting and corrosion, which can allow toxic metal particles to flake off of the hip and into surrounding tissue.
Shockingly, neither Stryker hip replacement was tested in human beings before coming to market. Instead, they were allowed to go through the U.S. Food & Drug Administration’s (FDA) 510(k) clearance process, which does not require a device to undergo human clinical trials if a manufacturer can show its design is “substantially equivalent” to a product already on the market. As a result, the flaws that prompted the Stryker hip recall would not be detected for several years, after the hip components were implanted in tens of thousands of patients.
Stryker Hip Recall
Unfortunately, the performance of the Rejuvenate and ABG II hip systems did not live up to Stryker’s promises. In April 2012, Stryker issued an “Urgent Safety Alert” to surgeons and hospital risk managers for the two hip replacement systems, warning that the generation of excessive metal debris caused by “fretting and/or corrosion at or about the modular neck junction” could “lead to increased metal ion generation in the surrounding joint space.”