Stryker Howmedica RECALL
When Was the Recall?
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.
Why are the Stryker Rejuvenate Hips Failing?
The Stryker Rejuvenate was only briefly tested in the laboratory prior to widespread sale to the public. The Stryker Rejuvenate is made with a modular femoral neck. This is a different design than the traditional hip implant devices. The traditional hip implant devices had two parts, a femoral stem with a ball on it and then a cup that is placed in the acetabulum of the pelvis.
The Stryker Rejuvenate has four parts. It has a femoral stem, a metal neck, a ball, and an acetabular cup. The proposed advantage of the multipart or modular design is that the surgeon has a number of different metal neck parts of slightly different lengths and angles that he or she can choose to use during the surgery to try to obtain the best angle and length for the implant.
The problem with this design is that each time you have a metal joint between two different metal parts 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. The fretting and corrosion of the metal parts releases metal debris into the patient's hip compartment where it will usually cause inflammation, fluid buildup and failure of the implant.
Risks and Symptoms
While the Stryker Rejuvenate recall is not considered a traditional metal-on-metal implant because it contains a ceramic cup, components of the recalled hip implant are metal and can lead to fretting. Because fretting or abrading can occur between the metal necks and metal stems in the devices, it can send chromium, titanium and cobalt particles into a patient's surrounding tissues and their bloodstream. This, in turn, can increase the risk of metallosis, which is a type of metal poisoning that can have long-lasting and serious effects on a sufferer. Here's why:
Since the immune system identifies the metal ions as foreign it automatically responds by inflaming the area and attacking the foreign cells. Unfortunately, healthy tissues can get caught in the crossfire causing further damage. Specific side effects associated with metallosis are:
- Hip joint failure
- Pain and discomfort
- Dead tissue
- Limited mobility
- Dissolution of the bone
- Avascular Necrosis - Another symptom that a faulty hip replacement can generate is avascular necrosis or osteonecrosis. It impairs the blood supply to the bone and most commonly affects the hips. This condition occurs when there is an interruption of the blood supply to the head of the femur (the ball, of the ball-and-socket hip joint). The lack of normal blood supply causes a decrease in delivery of oxygen and nutrients to the hip bone causing it to subsequently die. If this happens from a hip replacement recall or for other reasons, the bone can collapse.
- Metallosis - A case report by Stephen Tower published in the Journal of Bone and Joint Surgery, says patients with metal-on-metal implants experience high serum cobalt levels that place them at risk for cognitive and cardiac impairment. Most at risk are patients who have shell malposition or persistent hip pain, renal impairment, and hip implants. The study recommends close monitoring suggesting that a cobalt level of > 7 mg/L is indicative of possible periprosthetic metallosis.
BOWERSOX LAW FIRM, P.C. represents individuals who have been seriously injured by the Stryker Rejuvenate and AGB II hip implants. Our firm initiated investigations into the hip implant injuries before Stryker issued a voluntary recall of its products. If you find yourself in need of a Stryker Rejuvenate lawyer Contact BOWERSOX LAW FIRM, P.C. today for your free consultation.