When Were the Recalls?
The Stryker Recall for Certain V40 Femoral Heads (manufactured before 2011)
This recall was voluntarily issued by Stryker with some surgeons receiving the "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated August 29, 2016. This call involves specific Femoral Heads called the LFIT Anatomic CoCr (Cobalt/Chrome) V40 Femoral Heads that were manufactured prior 2011. These devices could have been implanted for some substantial period of time after they were manufactured. It would be very unusual for a patient to know the specific type of Femoral Head and date of manufacturing. If you have had a hip surgery and you are having pain, call us right away to find out if your hip device has been recalled! 800-255-1996. We represent clients nationwide.
The Stryker Rejuvenate and ABG II hip implant was recalled in July of 2012. The recall came three months after Stryker issued an "Urgent Field Safety Notice" to implant surgeons and hospital risk managers pointing out the potential health hazards associated with the two products - including corrosion and "fretting," which allows minute shards of its metallic components to leach into a patient's tissues, bones and/or bloodstream. 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.
Who Received Stryker Hip Implants?
Stryker told doctors that the multi-part modular design of the Rejuvenate would provide better surgical results because they would be able to get better adjustment of angle and lengths during surgery ensuring each patient was "custom-fitted" with the best length and angle for their specific size and activity level. This representation sounds logical because it was sometimes difficult for surgeons to get the exact angles and leg lengths that they would prefer with the two part hip implants. Since having gained FDA approval (the Rejuvenate in 2008 and the ABG II in 2009), and just less than five years since patients had these implants in their bodies, a large number of those patients have already suffered complications and have been forced to undergo revision surgery. It appeared that once implanted in patients and subjected to normal stress, the stem and neck could wear against one another, leaving metallic debris into a patient's surrounding tissues. This metal contamination-or poisoning-could then cause pockets of swelling, tissue damage, bone damage and loss, and premature hip failure.
How did the Stryker Rejuvenate and ABG II Gain FDA Approval?
According to reports, the Stryker hips were only laboratory-tested before being made available to the public. The U.S. Food and Drug Administration (FDA) granted approval for the devices based on Stryker's representation that the design was substantially similar to a product that had already been approved: Wright Medical Technology's Profemur Total Hip Modular Neck System. A recent medical paper from the 2012 American Association of Orthopedic Surgeons meeting reported that "there is currently no clinical evidence that the use of modular necks is associated with improved function or reduced consequences of femoral-pelvic impingement." This means that there is no scientific evidence that the theory of improved outcomes with these multipart or modular implants actually works in practice. It is just a theory and one that was promulgated to doctors as a sales pitch to sell more of the Stryker implants. Stryker never did clinical (that means on people) studies to see if the purported benefits of this product could justify the known risks of incorporating multiple metal junctions in a product designed to be implanted in the human body. Subsequently, under the FDA's 510(k) approval process, the Stryker implants were essentially "grandfathered" in with very little pre-market scrutiny.
What Type of Injuries are Associated With the Stryker Hip Implants?
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, necrosis (damage to tissue) and osteolysis (damage to the bone) in the hip compartment, and metallosis (a build-up of metallic debris).
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.
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.
Who is Stryker?
Stryker which is a division of Howmedica has contracted with a third-party claims processing firm called Broadspire to pay for out of pocket expenses not covered by insurance for Rejuvenate and 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.