The Stryker Hip Implant Recall and How It Affected Consumers

The Stryker hip implant recall was yet another among a growing number of metal hip implant recalls seen over the past few years. Recipients of the Rejuvenate and ABGII, were dismayed to hear of the Stryker hip implant recall in July, 2012. Since the two hip implant devices received FDA approval in 2008 and 2009, a significant number of adverse reports from consumers were sent to the FDA. Due to the controversial 510(k) approval process, no clinical trials of the hip implants were required; it was only necessary for Stryker to make a case that the Rejuvenate and ABGII were substantially equivalent to a device already on the market.

As the Stryker hip implant recall demonstrated, this level of approval is likely not sufficient to ensure the safety of consumers. After over sixty reports of ill health effects concerning the Stryker Rejuvenate and ABGII—and over 17,000 reports totalfor all metal hip implants reported between 2000 and 2011—it appeared that it was only a matter of time until the Stryker hip implant recall was put into place. Considering that only a small percentage of recipients will take the time to send a report to the FDA, it is possible the total number of adverse health effects is considerably higher.

At the time of the Stryker hip implant recall, Stryker declined to state the exactfailure rate of the Rejuvenate and ABGII implants. Following the Stryker hip implant recall, independent studies placed the number as high as 40%. This means that even those implant recipients who have not yet experienced ill health from the devices might in the future. The Stryker hip implant recall was instigated due to a higher than normal rate of failure due to fretting and corrosion which lead to the shedding of metal debris into the body.

This metal debris can cause inflammation, infection, chronic pain, implant failure, deterioration of bone and tissue as well as a variety of very serious health symptoms linked to metal poisoning. It is advisable for any recipient of the Rejuvenate or ABGII to have tests which measure cobalt and chromium in the bloodstream done as well as to speak with a knowledgeable Stryker hip implant recall attorney who can assess the individual’s situation and offer plausible options moving forward.