The Stryker Rejuvenate and ABG hip implant was recalled in July of 2012. These hips are failing at a high rate as a result of leaching of chromium and cobalt from the double modular neck of the implant. The joints in the modular neck components are corroding due to micro motion in the joints. The micro motion in the joint causes fretting and corrosion. This is a design defect in the product. Stryker had sent doctors promotional material stating that: “Laboratory testing demonstrates the compatibility of these materials without concern for fretting and corrosion.” So doctors had no reason to suspect that these hip implants were bad
This is why we think that Stryker will be held legally liable in the lawsuits that we are bringing against Stryker.
Patients with the Rejuvenate and ABG II hip implant are suffering from adverse reactions to the metal contamination that frequently require revision of the hip. These adverse reactions include inflammation, pain, limitation of motion, fluid in the hip compartment, damage to tissue in the hip compartment and damage to the bone.
The long term effect of this metal toxicity on the body is not well understood by doctors at this point. However, long term exposure to metal ions may have systemic effects on the nervous system or other organs in the body.
Stryker which is a division of Howmedica has contracted with an insurance adjusting firm called Broadspire to pay for out of pocket expenses not covered by insurance for Rejuvenate ABG II patients who need to pay for blood testing for metal levels or surgeries to replace the Rejuvenate ABG II hip implants. Broadspire is the same company that is paying out of pocket expenses for the DePuy ASR metal hip implant that was recalled in August 2010.
Initially, at the time of recall Stryker was not recommending that all Rejuvenate ABG II patients get regular blood testing for cobalt chromium levels. Recently, Stryker has changed its recommendations to include regular chromium cobalt blood testing every six months or once a year.
About twenty thousand Stryker Rejuvenate ABG II hips were implanted since 2009 when then the product was put on the market. The revision or reoperation rate is rapidly rising and it is possible that most patients will require replacement surgery.
Our office is representing Rejuvenate ABG II patients in lawsuits against Stryker and we are assisting patients in obtaining reimbursement for out of pocket costs and blood testing through the program with Broadspire. We expect that these lawsuits will be successful based upon the unreasonably high failure rate of these implants and the misrepresentation by Stryker that the hips would not be subject to fretting and corrosion.
The Stryker Rejuvenate Hip Recall for metal toxicity was a surprise to many patients and doctors because it is not a metal on metal hip. In fact, many patients selected this hip to avoid the metallosis problem that has been in the news for the last two years since the DePuy ASR metal on metal recall in August of 2010.
The Stryker Rejuvenate hip is made with a ceramic ball and a polyethylene liner in the acetabular cup. The recalled DePuy ASR and the recalled Smith & Nephew R3 hips both have a metal ball and a metal cup which is called a metal on metal articulation. The problem with the metal on metal hips is that the metal on metal interface generates metallic debris that is toxic to the tissues in the hip compartment causing fluid buildup, tissue damage, and failure of the implant.