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Wednesday, October 17, 2012

Preserving Your Right to a Stryker Hip Implant Lawsuit



If you or a loved one is the recipient of a Stryker ABGII or Stryker Rejuvenate hip implant device it is very important that you preserve your health, your future and your right to recovery. Between the time the devices received approval and hit the market (June 2008 and November, 2009) Stryker received reports of health and safety risks regarding the Rejuvenate and the ABGII. Surgeons across the United States submitted reports which voiced concern for the amount of corrosion and fretting seen in the devices which had been removed from their patients, with one surgeon stating it looked like “black rust” around the modular neck junction.

The April 2012 Urgent Safety Bulletin

In a safety bulletin sent to surgeons and hospitals in April of 2012, Stryker noted that excessive metal debris and ion generation were commonly seen in these Stryker hip implant models. Further, high levels of corrosion and fretting were resulting from the metal ion generation, leading to early failure of the device and the necessity of revision surgery. In this safety bulletin Stryker noted that a certain ph level in some patients caused them to be at a greater risk of harm. Further, they stated that tapers which were not adequately locked or sufficiently cleaned could lead to an increase in metal debris generation.

How the Rejuvenate and ABGII Gained FDA Approval 

Both the Stryker Rejuvenate and the ABGII received FDA approval through a process known as the 510(k). This process allows medical devices and drugs to skip clinical trials by asserting they are substantially similar to a device or drug which has already been approved. Of course the drug or device they are claiming to be similar to could have gained approval in the same way. In this particular case, the Wright Profemur was the device the Rejuvenate claimed to be substantially similar to, and the Profemur has had its share of adverse events among its recipients as well. This process causes unsuspecting patients to become guinea pigs as the manufacturer really has no idea whether or not the device or drug is truly safe. Most of us expect that our surgeons will not implant an unsafe device into our bodies, and most surgeons expect that an FDA approved device or drug can be considered safe. Unfortunately this is not always the case, and the metal-on-metal hip implants have had more than their share of troubles.

Don’t Lose Your Right to File a Claim against Stryker

It is believed that over half a million Americans currently have a metal-on-metal hip implant in their body which is, in some ways, akin to a ticking time bomb. When the metal ions shear away from the device they become lodged in the surrounding tissue and cause pain and inflammation or they make their way to the bloodstream where they can eventually cause metal toxicity. The symptoms of metal toxicity may lay dormant for as long as several years and if the patient has not preserved his or her right to recovery—by speaking to an experienced Stryker hip recall attorney—they could find themselves with damaged health and a mountain of medical bills following revision surgery.

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