Stryker Rejuvenate and ABG II Hip Implant Lawsuit
If you have been injured due to hip replacement, you may be eligible for compensation. For a free legal consultation, please fill out the form to the right or contact us directly at 888.584.0411.
The FDA has received numerous reports of Stryker hip recall problems relating to the Rejuvenate and the ABG II devices. Problems associated with the faulty hip replacements include:
- Damage to bone and tissue surrounding hip joint
- Hip replacement failure
- Loosening of implant
Not sure if your hip implant was recalled? You can find this information in your medical records, or contact us at (888) 584-0411 or via the form on the right for further assistance.
A voluntary hip recall was issued on July 6, 2012 by Stryker Orthopaedics in direct response to growing patient complaints of its Rejuvenate and ABG II modular-neck stem implants. This action, along with company's earlier Urgent Field Safety Notice for Corrective Action in April 2012, is spreading much concern among the medical community and patients alike. In its Field Safety Notice to surgeons and physicians, the company stated that its hip replacement Rejuvenate Modular Stems and Necks reportedly suffered from excessive metal debris (causing metallosis) and excessive fretting (deterioration) that could result in required revision surgery.
Below Seeger Weiss offers you and your loved ones more information about the problems associated with the two hip recalls and potential risks patients might encounter. If you suspect a problem, please don't hesitate to contact us for a FREE consultation by completing the form to the right.
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
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.
Another symptom that a faulty hip replacement can generate is avasucular 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.
What's At Stake?
Instead of having an implanted artificial hip lasting 10-15 years, some patients encounter faulty hip replacement problems within the first 18 months, with few options available. Many afflicted will have to undergo revision surgery, which carries greater risk and complications. For instance, revision hip replacement surgery can be more complicated than the first hip replacement. Quality of the bone and the ability to adequately secure the revision hip replacement into position are two challenging technical issues that the surgeon and patient must face.
Faulty Hip Implants
Instead of employing a one-piece femoral stem and neck for their hip implant, Stryker designed the Rejuvenate and ABG II devices to employ a two-piece modular neck and stem for enhanced stability and flexibility. Apparently, the design allows surgeons to choose a range of femoral neck and stem combinations to better personalize the implant to a patient's unique anatomy.
But shortly after the breakthrough devices were announced in June of 2008, reports started surfacing about Stryker hip implants. 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.
Have You Been Affected?
It's been less than four years since Stryker has had to deal with a highly publicized hip replacement recall. In 2008, their Trident Hemispherical and Acetabular PSL cups were recalled due to many issues including questionable manufacturing practices. Seeger Weiss—and thousands of hip replacement patients across the nation—believe the company should have learned their lesson. They need to stop causing more suffering to patients who just want to walk without pain and go about their daily activities in a normal, pain-free way. If you or a loved one has suffered, let us help you seek potential monetary damages as compensation.
If you or a loved one has suffered an injury related to Stryker hip replacements, you may be eligible for compensation. For a free legal consultation, please fill out the form to the right or contact Seeger Weiss LLP directly at 888.584.0411 to speak with a lawyer regarding a lawsuit.