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Illinois Woman Files Stryker Hip Recall Lawsuit

On May 3, 2013, an Illinois woman filed a Stryker hip recall lawsuit in the U.S. District Court for the Northern District of Illinois. After undergoing a hip replacement procedure, the plaintiff allegedly suffered severe complications as a direct result of receiving a defective Rejuvenate Modular Hip System. The plaintiff is seeking compensatory and punitive damages from Stryker Corporation and its subsidiary, Howmedica Osteonics Corporation.

Stryker’s Rejuvenate Modular Hip System, Trident Acetabular Cup System, and ABG II components have been linked to serious complications such as inflammation, soft tissue damage, bone loss, and infection. Stryker issued a voluntary recall for certain devices due to the safety hazards they posed to patients. Hundreds of patients filed a Stryker Trident lawsuit and pursued litigation regarding other defective hip devices in order to be compensated for their losses.

Rejuvenate Modular Hip System complications

Stryker marketed the Rejuvenate Modular Hip System as a hip implant that would enhance stability and provide more flexibility for patients. The hip replacement could be used with interchangeable components that enabled surgeons to customize the fit of the implant to the anatomy of each patient. Stryker designed the Rejuvenate Modular Hip System to last longer and be more effective than the hip devices created by competitors.

Corrosion and fretting of metal components was a major problem for traditional hip implants, but Stryker claimed that it wouldn’t be an issue with their product since the neck piece that fit against the acetabular cup wasn’t metal. In spite of Stryker’s assertions, corrosion became a complication because the other end of the neck piece was metal and it connected into a metal hip stem. As the patient performed basic movements, it added stress to the metal parts of the hip implant and corrosion occurred. When there is corrosion and fretting, it increases the risk of metal contamination in the surrounding soft tissues in the patient’s body.

Lack of clinical safety tests for Stryker hip replacements

On June 3, 2008, the Rejuvenate Modular Hip System received FDA clearance under the 510(k) approval process. Under section 510(k) of the Federal Food, Drug, and Cosmetic Act, a medical device can receive FDA approval without undergoing clinical trials if it is considered substantially equivalent to a product that is already in the market. Since Stryker wasn’t required to conduct clinical safety tests before releasing the device, consumers and healthcare providers didn’t become aware of the design flaws until the implants were used and the results from post-marketing studies were disclosed.

Some of the health problems sustained by patients are metal toxicity, bone fractures, tissue necrosis, organ failure, pseudotumors, and chronic pain. Patients who experienced serious injuries underwent revision surgery. In April 2012, Stryker issued an Urgent Safety Notice to inform medical professionals that patients who received the Rejuvenate implant were at risk of developing metal poisoning due to corrosion and fretting of the metal components. Two months later, the hip device was removed from the market after a voluntary Stryker hip recall was issued for the Rejuvenate and ABG II systems.

Plaintiff underwent revision surgery

On May 17, 2011, the plaintiff underwent total hip replacement surgery after being diagnosed with osteoarthritis in her left hip. Components of the hip implant included a Rejuvenate modular stem, a Rejuvenate modular neck, and a Trident 54mm acetabular shell with a Trident poly insert. The plaintiff started to experience pain, discomfort, an adverse tissue reaction, and inflammation a few months later. Her physician performed revision surgery on the left hip prosthetic on September 11, 2012. In spite of getting extensive medical treatment after the revision surgery, the plaintiff continues to have neck problems, back pain, and walks with a limp.

According to the lawsuit, a defective hip replacement system and the defendants’ wrongful conduct were the proximate cause of the plaintiff’s injuries. The causes of action include negligence, fraudulent misrepresentation, and failure to warn. The Stryker hip recall lawsuit states that the defendants knew or should have known that their product could potentially pose health risks to patients since other metal-on-metal hip devices were plagued by similar safety issues. The complaint also alleges that the defendants were negligent since they designed a defective product and didn’t conduct sufficient clinical safety tests prior to distributing it. The plaintiff is requesting compensation for her medical expenses, financial losses, and pain and suffering.