In May, an Illinois man filed a $100 million defective medical product liability Stryker hip lawsuit in the U.S. District Court for the Northern District of Illinois. According to the plaintiff, he received an ABG II implant during hip replacement surgery. The plaintiff alleges the ABG II system was defective and it caused him to sustain permanent injuries. Plaintiff claims that Howmedica Osteonics, and Stryker Orthopaedics was negligent and failed to warn patients about the risks associated with the hip replacement system.
The Stryker ABG II system is a metal and metal hip implant composed of interchangeable chrome cobalt neck and titanium stem components. The FDA allowed Stryker Orthopaedics to market and distribute the hip replacement system in 2009.
The hip implant was approved under the FDA’s controversial 510(k) Premarket Notification Process which does not require a manufacturer to conduct clinical safety trials if its device is substantially equivalent to another device that is already in the market.
Stryker Orthopaedics stated that components of the hip replacement system could be custom-fitted for patients, provided greater flexibility, and were more resistant to corrosion.
But post-market data challenged these claims when it was found that the ABG II System grind against each other, loosened from its original position, became corroded and released metallic debris into the bloodstream and soft tissues.
These problems associated with the hip device led to early failure rates and allegedly harmed the patients’ health.
Stryker ABG II Metal Hip Problems
In April 2012, Stryker Orthopaedics issued an Urgent Field Safety Notice to inform medical professionals that the hip device posed a potential safety risk to patients due to corrosion and metal contamination.
According to FDA adverse event reports, some of the medical complications include inflammation, metallosis, tissue damage, bone loss, chronic pain, and pseudotumor formation. In order to prevent the injuries from getting worse, some patients needed to undergo revision surgery so that the defective hip implant could be replaced.
The Stryker hip lawsuit alleges that the defendants designed, manufactured, and distributed a defective medical device. According to the plaintiff’s attorney, the hip implant is unreasonably dangerous and unfit for its intended purpose. The defendants allegedly failed to adequately test the safety of the product prior to distributing it and didn’t warn patients of the safety risks associated with using the product.
Stryker Hip Rejuvenate and ABG II Implant Recall
On July 6, 2012, Stryker Orthopaedics decided to voluntarily recall the ABG II System from the market. Patients were advised to contact their doctors in order to confirm if they received the ABG II modular-neck stems. Physicians were encouraged to conduct the necessary examinations and tests in order to verify if patients were suffering from any adverse side effects due to a defective hip implant.
The U.S. Judicial Panel for Multidistrict Litigation is considering consolidating the lawsuits. On May 30, 2013, attorneys presented oral arguments to the Judicial Panel regarding the possible federal consolidation of the Stryker hip implant cases.