Stryker Hip Revision Surgery
Despite the technological advances incorporated into the design of the hip replacement prosthetics manufactured by the Stryker company, hundreds of lawsuits continue emerging secondary to complications associated with the products. Reports indicate that approximately 20,000 individuals in the United States received either the Stryker ABGII or Rejuvenate Hip Stem systems since the devices gained FDA approval in 2010.
Arthroplasty Using Stryker Devices
Hip athroplasty, commonly called hip replacement surgery, entails removing damaged or diseased connective tissue along with the ball and socket hip joint. Orthopedic surgeons then replace the joint with synthetic materials. The Stryker devices consist of a singular neck and stem design that offers interchangeable components of different sizes, which allows customization for each patient. Physicians insert the appropriate size stem into the top of the femur. A synthetic ball fits into the end of the neck, which attaches to the acetabular space forming the hip. Patients often undergo the surgical procedure when degenerative arthritis, hip fractures or systemic disease processes cause chronic pain and mobility impairment.
Complications Associated with Stryker Implants
The stems of the athroplastic prosthetics contain a blend of titanium, molybdenum, zirconium and iron. Stryker engineers designed the implants to resist corrosion and stress damage from natural movement that often affects metal-on-metal, ball and socket devices. However, the necks of the implants consist of a chromium and cobalt base and the stems have a titanium coating. The connection point of the two components creates a metal-on-metal joint that causes complications commonly found with older model implants.
Stryker discovered that patients having the new system design began experiencing a condition known Adverse Local Tissue Reaction from the degradation of the metal joint. Even minute shavings or particles released from the implant cause toxic process called metallosis. The condition may exist before patients experience noticeable symptoms. Left untreated, the foreign particles cause a gradual death of the local bone, muscle and connective tissues. The bones weaken and may fracture. The fragments may also enter the bloodstream and cause metal poisoning. Some patients suffer tumor-like growths. The symptoms of metallosis might also include allergic reactions, immunological disorders and in extreme cases, death.
Individuals having these prosthetic devices may experience sharp pain, bruising, reddening and swelling. As the irritation continues, the implant may dislodge. Diagnosing the problem generally requires having imaging studies and blood tests to check for toxic levels of the metals. Physicians consider blood samples containing traces of metal at levels of seven parts per billion toxic.
Patients suffering metallosis undergo corrective surgery, which presents possible further complications. As the stem lies deep within a femur that may contain weakened bone, revision procedures carry a high risk for causing fractures when attempting implant removal. Surgeons then must repair fractures in addition inserting replacement implants. The trauma created means recovery time for revisions also last considerably longer than the initial surgery.
Testing Short-Cuts Led to Problems
Stryker received Federal Drug Administration approval without having to finance clinical trials by submitting the product models though a program known as the 510(k) Pre-market Notification Process. If creating a product similar to devices currently marketed with FDA endorsement, manufacturers bypass testing regimens and receive approval. However, the administration did not take into consideration that previously sanctioned metal-on-metal implants have a tendency for complications. Possible product defects also do not surface until after implantation.
Oddly enough, Australian physicians discovered the first signs of defects. The country has a vast joint replacement registry, which enables accurate tracking of implants. By the spring of 2012, the FDA received over 80 complaints concerning the ABGII and Rejuvenate Hip Stem systems, which initiated a product recall. The number of affected patients steadily grew. Stryker issued a formal safety alert in the summer of 2012 to hospitals and surgeons.
Implant Trauma Compensation
Attorneys in New Jersey and other states established class action lawsuits against the company in hopes of obtaining appropriate compensation for patients having Stryker implants. Charges include negligence concerning inadequate safety testing and failure to warn consumers and health care professionals about product defects and possible adverse reactions.