The Stryker Hip Recall Lawsuit: What Problems Led to the Stryker Recall?

The official reason for the recall was the higher-than-normal risk of corrosion and fretting at the neck juncture of the implant, however since that time many more issues have come to light. The four small metal trunnions located at either end of the neck portion of the Rejuvenate were found to suffer corrosion when body fluids become trapped underneath. Further, higher levels of cobalt were found to be coming from the Morse taper which is a slightly angular junction between the stem and the neck.

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Increased Metal Levels from Stryker Hip Implants: Cobalt Metal Poisoning from Recalled Stryker Rejuvenate & ABGII Hips

Patients with Stryker ABGII or Rejuvenate hip implants could see a wide variance between the cobalt and chromium levels with the cobalt levels being considerably more elevated. The probable reason for the difference in these numbers is that the wear in the Rejuvenate and ABGII hip implants does not come from the cup and ball portion of the joint rather it comes from the stem and neck. The design of these Stryker devices implements a Morse taper between the stem and the neck.  The Morse taper is a slightly angular junction which the physician hammers into the stem until it is snug, then hammers again so it will lock tightly.

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Stryker Hip Recall: Measuring Stryker Rejuvenate Hip Failure Symptoms – ALVAL and Cobalt Elevated Levels

If ALVAL is suspected—usually when the patient suffers consistent groin pain which restricts their normal activities—tests for infection should be considered. Should there be an absence of infection yet the groin pain continues, revision to an implant made of a different substance may be recommended.
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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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