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Kentucky Plaintiff Claims Stryker Rejuvenate Failure

Kenneth Collins, a Kentucky resident, has filed a Stryker Rejuvenate recall lawsuit against Howmedica Osteonics Corp., doing business as Stryker Orthopaedics. The complaint was filed on June 26, 2013 and is currently proceeding in the U.S. District Court for the Western District of Kentucky under Chief Judge Joseph H. McKinley, Jr. The lawsuit claims the defendants manufactured and sold a defective hip implant, which caused the plaintiff significant physical injuries. The plaintiff is seeking actual and punitive damages in excess of $75,000.

Plaintiff requires hip replacement revision surgery

The plaintiff underwent a total left hip replacement surgery on July 12, 2010. This type of surgery is commonly recommended for patients who experience significant pain and range of motion limitations in a joint, due to factors such as physical trauma and osteoarthritis. The plaintiff received the Rejuvenate hip implant, manufactured by Stryker Orthopaedics. Although the surgery was intended to improve the plaintiff’s quality of life and overall health, Collins reported severe pain and discomfort following the surgery.

Initial diagnostic tests were unable to determine the source of the plaintiff’s discomfort. However, the plaintiff subsequently underwent further testing, which revealed that the hip replacement had failed. The plaintiff was forced to undergo Stryker hip revision surgery to remove the failed hip implant and replace it. The revision surgery took place on January 18, 2013.

However, according to the complaint, Collins continues to suffer from physical injuries, pain, and emotional distress as a result of his experience with the defective hip replacement. The plaintiff has also incurred significant medical, pharmaceutical, and rehabilitative expenses, and expects to continue to require medical care in the future.

Defendants issued Stryker hip recall

The Rejuvenate Modular and ABG II modular-neck hip stems, which are known as metal-on-metal hip implants, were first approved by the FDA on June 3, 2008. The defendants requested a 510(k) method of approval, which allowed them to bypass the rigorous testing normally required of medical devices that are pending approval. The Stryker Rejuvenate recall lawsuit notes that this implant is unique because it consists of a chromium-cobalt neck connected to a titanium stem. The system was marketed to healthcare professionals as an ideal way to allow surgeons to more closely customize the device to suit each patient’s unique needs. However, reports have noted the potential for galvanization, fretting, and corrosion of the metal components, leading to failure.

Although the defendants had previously claimed that no such problems existed with the Rejuvenate system, Stryker Orthopaedics issued an Urgent Field Safety Notice in April 2012, notifying healthcare professionals of the potential for failure of the device as a result of corrosion heavy metal contamination. Despite the severity of the complications, the defendants waited until July 2012 to issue a voluntary recall of Stryker Rejuvenate and ABG II systems.

Allegations leveled in Stryker Rejuvenate recall lawsuit

Unfortunately, the voluntary recall came too late for the Kentucky plaintiff. Collins’ lawsuit claims that Stryker was negligent in designing, manufacturing, and marketing the Rejuvenate system. According to the complaint, the defendants “failed to use reasonable and due care for the safety” of patients, and that they failed to adequately test the device prior to marketing it. The lawsuit further charges the company with failing to act swiftly with regards to the initial reports of device failure. Other allegations raised by the plaintiff’s Stryker lawyer include breach of express and implied warranties, designing a defective product, manufacturing a defective product, and failing to warn patients and healthcare professionals of the risks.