On July 6, 2012, Stryker Orthopedics announced that it was voluntarily recalling its Rejuvenate and ABG II modular-neck hip stems and stopping global production of these devices. This was done in response to mounting evidence that these products are prone to fretting and corrosion at the metal modular neck junctions, resulting in the breakdown and release of toxic metal debris into the soft tissues surrounding the hip, which causes pain and/or swelling at the local joint site. In addition, these toxic metal particles may also enter the bloodstream.
Unlike other metal on metal hip implants which have been the subject of recalls and litigation, such as the Zimmer Durom Cup and the DePuy ASR™ and ASR™ XL hip implant systems, the Stryker Rejuvenate hip implant system does not involve a metal on metal ball and cup design. Instead, the Stryker Rejuvenate is made with a modular femoral neck. This is a different design than the traditional hip implant devices. Traditional hip implant devices have two components: a femoral stem with a ball on the end, and a cup that is placed in the acetabulum of the pelvis.
The Stryker Rejuvenate has four parts:
Stryker touted the advantages of this modular design as providing greater options to the implanting surgeon. Because there are number of different metal neck parts of slightly different lengths and angles the surgeon can choose from, the surgeon has greater options in terms of the angle and length of the implant.
Unfortunately, the problem with this design is at the joints between the modular components. The Stryker hip implant necks are made of cobalt and chromium, and the stems are coated with titanium. Because the modular components are made of metal, there is a risk of fretting from the movement in the metal joints and subsequent corrosion of the metal neck either at the joint with the femoral stem or the joint where the neck segment is inserted into the ball.
When these metal junctions undergo friction during periods of activity, microscopic metal particles can shear away from the implant, lodging into the nearby tissue and/or entering into the bloodstream.
Excessive metal debris can enter the body as a result of corrosion leading to extreme inflammation and swelling, pseudo tumors, pain and tenderness at the joint site, a notable decrease in mobility, toxic metal poisoning, loosening of the hip joint, tissue damage and death, and extreme bone loss, called osteolysis.
In most cases, patients who have developed any of these problems will require revision surgery to remove the implant. That is the only way to put an end to the breakdown of metal debris. This is a very long, complicated and potentially risky surgery, because it requires removal of not only the neck component, but also the femoral stem, which was driven down into the shaft of the femur and cemented into place during the initial hip replacement procedure.
Those who received a Stryker Rejuvenate or ABG II should see their orthopedic physician as soon as possible, regardless of whether they are currently experiencing any symptoms. Stryker has advised patients who received one of these devices and who are experiencing pain to undergo MRIs, X-rays, and blood tests to check metal ion levels.
If you underwent a hip replacement in which a Stryker Rejuvenate or ABG II hip system was used, contact our office today to discuss your legal rights with one of our defective hip implant attorneys. At Cannon Dunphy S.C. we can investigate your case and help you determine the strength of your claim.
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