Monday, January 27, 2014

What Went Wrong With the Stryker Rejuvenate?

The Stryker Rejuvenate hip implant device, along with the Stryker ABGII, was recalled in July, 2012. It was noted at the time the Stryker Rejuvenate was recalled that the device had a higher-than-normal risk of fretting and corrosion, particularly at the neck juncture and underneath the metal trunnions. Since the recall, more and more information has come to light regarding the Stryker Rejuvenate and the design flaws which may be responsible for the accumulation of metal ion debris in the bodies of Stryker Rejuvenate patients.

The design of the Stryker Rejuvenate was considered extremely innovative and was believed to be a much safer alternative to the “true” metal-on-metal hip implants, in part because a ceramic ball was used. Surgeons were able to choose different lengths and angles of the individual components in order to better match the implant to the individual patient’s body type and activity level. The Stryker Rejuvenate has a longer stem than the ABGII—a design that has led to more problems when revision surgery becomes necessary. The longer stem is planted deeply within the femur bone of the implant recipient during the original surgery. Should the patient develop metallosis or metal toxicity and a revision become necessary, the stem in many cases must literally be pried out of the femur.

Stryker Rejuvenate revision surgeries have been known to result in a shattered femur bone, and the necessity of rebuilding the bone before a new implant can be placed. The coating on the Stryker Rejuvenate, hydroxyapatite, is porous, rough and deep. This encourages the bone to grow more deeply into the coating, however once again, should a revision surgery be necessary, it is more difficult to remove the defective Stryker Rejuvenate. Other problems of the Stryker Rejuvenate include mismatched components and frictional torque. More than one study has shown that when metal alloys are mixed, corrosion may be much more likely where the metals come together.

A galvanic reaction which creates corrosion when the titanium stem and cobalt and chromium adapter sleeve meet has also been noted in the Stryker Rejuvenate. Although researchers are not entirely sure why this galvanic reaction occurs, studies have proven that a significantly increased level of cobalt ion debris sheds from the hip device when the components of an implant have mixed alloys—like the Stryker Rejuvenate. The metal ions which shear away from the Stryker Rejuvenate following corrosion, either lodge in the hip tissue or enter the bloodstream. Those Stryker Rejuvenate ions which burrow into the hip tissue can cause inflammation, infection, chronic pain, loss of bone and degradation of tissue—all of which can be responsible for total hip failure.

The ions which enter the bloodstream can cause gastrointestinal disorders, cardiovascular, thyroid, renal and neurological disorders, skin problems, hearing and vision loss, disruption of DNA, vertigo, memory loss, depression, anxiety and irritability and the formation of pseudo-tumors. These Stryker Rejuvenate symptoms are known collectively as metal toxicity or metal poisoning and are extremely serious. Those who have been implanted with a recalled Stryker Rejuvenate must see their physician and have tests to determine whether their cobalt and chromium levels are unduly high. It could also be in the best interests of Stryker Rejuvenate recipients to speak to an experienced product liability attorney in order to determine the best way to recoup medical expenses and lost wages due to the defective Stryker Rejuvenate hip implant.

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