The Stryker Corporation is one of the world’s leaders in medical device technology and innovation. According to Fortune 500’s 2013 list, they rank No. 305. They also rank No. 61 in the Fortune 500 list of Best Companies to Work For.
Based in Kalamazoo, Mich., the company has recently found itself under scrutiny due to complications with two of its hip replacement systems – Stryker Rejuvenate and ABG II modular-neck hip stems. Released in 2009, these two hip replacement systems have resulted in thousands of complaints by patients who have suffered corrosion and fretting of devices after implantation. Stryker issued the recalls in July 2012.
According to literature provided by Stryker for healthcare professionals, the ABG II system is made up of several modular components and helps stabilize while minimizing bone stress. The stem is manufactured using a proprietary titanium alloy blend of titanium, molybdenum, zirconium and iron (referred to as TMZF). The neck of the ABG II is made of a cobalt-chromium alloy.
Initially developed as a superior alternative to plastic or ceramic orthopedic implants, metal-on-metal hip replacement systems, like the ABG II, have fallen out of favor in the medical community due to the deterioration of certain metals. According to data released by the FDA, metal-on-metal devices are more likely to fail than ceramic or plastic devices because of the wearing that occurs when the ball and socket rub against each other during movement.
Problems can occur as a result of the mating of the titanium alloy stem and the cobalt-chromium neck. The two metals create an electrochemical reaction that results in corrosion and fretting or flaking of the metal. The dislodged, toxic metal particles released into the surrounding tissue result in adverse local tissue reactions, as well as pain and swelling at or near the hip. Investigations have also found that chromium and cobalt ions that spread throughout the body can damage lymph nodes, the spleen, liver and kidneys.
While some patients experience no symptoms at all, others may notice infection-like symptoms, such as pain and tenderness or swelling. Some may also experience the following:
More noticeable symptoms may include:
According to recall information provided by the Stryker Corporation, “This voluntary recall was initiated due to potential risks associated with modular-neck stems. While modular neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, as part of Stryker’s commitment to supporting the health and well being of patients we decided to voluntarily recall these modular-neck stem hip systems.”
Patients suffering from hip pain and swelling who may have received a hip replacement using the ABG II modular-neck system should schedule an appointment with the surgeon who performed the replacement in order to verify the type used. Blood testing and imaging can be done to see if metal corrosion has occurred.
If you or a loved one has experienced pain and suffering due to complications from the Stryker ABG II modular-neck hip replacement system, please contact Ward Black Law today. We can help you understand your rights, and work to ensure you are compensated for your suffering.
One of our qualified attorneys will review your case with you and determine your legal options. We can help answer your questions about corrosion and fretting, as well as any questions about making a claim. We can also function as a “go-between” for you, handling all communication for you with insurance and Stryker’s claims administrator.
Contact us today online, by email, or call at 1-800-531-9191.
For more information about the Stryker ABG II hip replacement system and the recall, please reference the following sources:
Stryker – Patient Follow-Up FAQs
Stryker – Patient Recall Info
FDA – Metal-on-Metal Hip Implants
US News – FDA Probing Safety of Metal-on-Metal Hip Implants
CBS News – Metals from hip replacements present toxic risk for millions, investigation warns