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The Stryker Hip Recall—How Will It Affect You?
Although Stryker’s Rejuvenate and ABGII hip implants debuted to high hopes for a safer, longer-lasting metal hip implant in February, 2010, those hopes were soon dashed as it appeared these two devices could bring serious health risks to consumers. The Stryker hip recall occurred less than three years later, in July, 2012. The Rejuvenate received FDA approval in June, 2008, and the ABGII in 2009, both under the umbrella of the controversial 510(k) approval process.
At the time of the release of the ABGII and Rejuvenate, Stryker claimed the new, innovative design of the two devices would make them not only safer than other metal-on-metal hip implants but much longer lasting than most all hip implants on the market. These claims failed to materialize, and, in fact, within months of implantation, many patients were experiencing serious, adverse side effects related to the Rejuvenate or ABGII. Unlike other all-metal hip devices, Stryker used a ceramic ball in these two new designs, and offered a variety of neck and stem components which allowed surgeons to custom-fit the hip implant to the individual patient, according to size, body type and level of activity.
After receiving over 300 adverse event reports between the release of the two Stryker implants and early 2012, Stryker issued an urgent field safety notification to hospitals and surgeons which noted both models had a higher-than-normal rate of failure and were prone to fretting and corrosion at the neck junction. This fretting and corrosion in turn caused the release of cobalt and chromium ions into the bloodstream and hip tissues. When the metal ions land in the hip tissues, symptoms of metallosis such as pain, inflammation, tissue and bone necrosis and hip failure can occur, and when the cobalt and chromium ions make their way to the bloodstream, the following serious health disorders can occur:
- Renal failure
- Thyroid issues
- Cardiovascular, neurological and gastrointestinal disorders
- Memory loss, vertigo, skin rashes, headaches
- Irritability, anxiety, depression
- Diminishment of vision and hearing
- DNA disruption and the development of pseudo-tumors
- Reproductive disorders