Monday, November 19, 2012

The Many Difficulties in Diagnosing Problems in Recipients of Stryker Rejuvenate Hip Implants

The Stryker Rejuvenate and ABGII hip implant systems were voluntarily recalled by the company in July of 2012. The recall cited potential fretting and corrosion at the neck juncture as the primary reason for the recall. New information, however, points to a different reason for the corrosion and possible metal ion release. The Stryker Rejuvenate is different from the metal-on-metal hip implants which were recalled. Those metal parts of those implants rubbed against one another, causing metal shards to shear away, lodging in surrounding tissue or entering the bloodstream. The Rejuvenate has a ceramic ball, rather than a metal one with a plastic liner in the acetabular cup. Because of this, the Stryker Rejuvenate design was considered both innovative and, more importantly, safer than the all-metal hip implants.

Where Does the Problem Lie?

In fact, the problems with the Rejuvenate may not lie so much in the modular neck junction, rather in the trunnions located on either side of the neck piece. These trunnions are akin to divets in that the neck piece slips down into the trunnions. When the Rejuvenate is implanted in a patient, the stem is placed into the femur, then the neck--which has trunnions on both ends--pops onto the stem on one end and the ball on the other. The ball then fits inside the acetabular cup. The neck portion of the Stryker Rejuvenate is made of chromium and cobalt and the stem is titanium-coated. Stryker manufactured the neck and stem in a two-part design to give surgeons more choices in fitting the size of the implant to the size of the patient as well as to the patient’s activity level.

Where the Corrosion Could Be

It appears that the corrosion, believed to be contained to the neck juncture, may actually be occurring in the trunnion region as bodily fluids are trapped inside the trunnions. Because the trunnions are small, the level of metal surface scraping against metal surface is not as significant as in the all-metal implants however cobalt and chromium levels in the patient can be significantly elevated due to the corrosion of the trunnions. Elevated levels of cobalt and chromium can lead to chronic pain, infection, early failure of the implant, necrosis, metal toxicity and pseudo-tumors in the surrounding hip area. Any amount of toxic metals in the body is too much and when patients walk frequently or engage in higher levels of activity, the trunnions may jostle even more, leading to further corrosion. A serious issue associated with this new discovery of trunnion erosion lies in the fact that until very recently physicians were not aware of what they should be looking out for in their patients with the Stryker Rejuvenate hip implant.

What Orthopedic Surgeons Didn’t Know—Could Hurt Patients

The recall gave surgeons a starting point, telling them to look for corrosion at the neck juncture, but up until that time period in July of 2012, it is likely there was no mention of fretting or corrosion in the many Stryker implants which have required removal during revision surgery. Even now the trunnion corrosion is not being widely mentioned. Orthopedic surgeons who have performed thousands of hip implant surgeries as well as scores of revision surgeries will have made no mention of corrosion or wear, particularly in the trunnion area. No documentation on operative reports will exist to show the issues with these implants. In patients who are having severe pain or other health issues the physician will likely order x-rays, MRIs and bone scans. However, if physicians don’t know to look for corrosion in the trunnion region, those problems will not be noted on the patient’s reports.

Patients who complained about pain or other problems might have had their health fears dismissed simply because their physician didn’t know what to look for. Many physicians may have chalked up their patient’s worries and pain to advanced age or other external factors rather than attributing them to the corroded trunnions in the Stryker Rejuvenate hip implant. Patients may have been misdiagnosed and there may be no mention of corrosion in the neck juncture or in the trunnions in revision reports. This lack of up-to-date information regarding the Rejuvenate may have further damaged the health of implant recipients.

Author: Sullo & Sullo Attorneys

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