Cobalt Poisoning From Hips: Stryker Rejuvenate Received 510k FDA Approval as Opposed to Full PMA Approval

Although the Rejuvenate was approved in 2008, it was done through an FDA process known as the 510(k) which is more a clearance than an actual approval. This type of clearance is granted based on the fact that the device is substantially equivalent to a device already on the market.
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ALVAL and Metallosis among Stryker Rejuvenate and ABGII Hip Implant Patients

ALVAL (aseptic lymphocyte dominated vasculitis associated lesion) is a histological soft-tissue reaction in the body to all-metal implants such as the Rejuvenate or ABGII. ALVAL is not entirely understood however some research points to a link between ALVAL and bone dissolution.
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Rejuvenate & ABGII Lawsuits: The Status of Stryker Rejuvenate & ABGII Hip Claims in the United States

Following the recall, Rejuvenate lawsuits have increased and are likely to continue to increase as more implant recipients discover they have suffered harm from the metal-on-metal implant. As the litigation progresses, there are two primary litigation centers. One is the already-established New Jersey consolidated litigation which will be called a multi-county or multi-district litigation.

 

As the litigation progresses, there are two primary litigation centers. One is the already-established New Jersey consolidated litigation which will be called a multi-county or multi-district litigation.
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Osteolysis—One of the Dangers and Side Effects of the Stryker ABG II and Rejuvenate Artificial Hip Implants

Metal Hip Implant devices such as the Styrker Rejuvenate or ABGII, which implement a metal femoral component and plastic cup, can create polyethylene particles which in turn lead to osteolysis or bone loss surrounding the hip implant. Osteolysis occurs when an implant device is placed in the body and the device releases particles. The body reacts by attempting to remove those particles...
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Tests Available to Detect Metal Poisoning in Stryker Hip Implant Recipients

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