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Tuesday, January 28, 2014

The Problems Associated With the Recalled Stryker Rejuvenate



Like the Stryker ABGII, the Stryker Rejuvenate was recalled over a year ago, in July, 2012. At the time of the recall, Stryker officials stated the Stryker Rejuvenate had a higher-than-normal rate of failure due to corrosion and fretting, leading to metal ion debris being released into the bodies of patients. Stryker chose to use a ceramic ball in the Stryker Rejuvenate rather than a cobalt and chromium ball as well as creating a dual modularity design for the Stryker Rejuvenate. The design features of the Stryker Rejuvenate allowed surgeons to custom fit each hip implant device to the individual patient’s body type and activity level.

The Stryker Rejuvenate was geared toward younger, more active patients, and most of the thousands of patients who received a Stryker Rejuvenate believed it to be a safer alternative to the all-metal hip implant devices. Unfortunately those beliefs were shattered when patients began seeing adverse health symptoms soon after they received their Stryker Rejuvenate implant. A combination of issues in the Stryker Rejuvenate worked together to create a potentially dangerous hip implant device. The longer stem of the Stryker Rejuvenate made it more difficult to remove should a revision become necessary. The coating on the implant was thick and particularly porous, to encourage the bone to grow into the implant, once again making it more difficult to remove.

A serious mismatch between the titanium stem portion and the cobalt and chromium neck could also be responsible for the extremely high levels of metal ions released in Stryker Rejuvenate patients. Studies done over a decade ago found corrosion to be significantly higher in hip implants—such as the Stryker Rejuvenate—which used dissimilar metals. A more recent study noted that a galvanic reaction occurred when the titanium stem and chromium and cobalt adapter sleeve of the Stryker Rejuvenate were mixed. Researchers believe that galvanic reaction occurs due to the harder cobalt and chromium metals.

Patients who have a Stryker Rejuvenate hip device implanted in their body should be alert for any adverse health effects; metal toxicity can cause a variety of symptoms such as loss of hearing and vision, vertigo, depression, anxiety and irritability, skin disorders, DNA disruption, cardiovascular, neurological, gastrointestinal, renal and thyroid disorders, some forms of cancer, reproductive issues and loss of memory.

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