Stryker Hip Replacement Lawsuit

In recent years, medical device manufacturing giant Stryker Orthopaedics has been embroiled in legal battles regarding several of its widely used products. Plaintiffs who have filed Stryker hip lawsuits claim that the company should be held liable for manufacturing defective products and for failing to warn of known dangers associated with their hip implant devices.

Several of the models named in legal complaints in fact have been recalled including the Trident hip device, the Rejuvenate model and ABG II system.

Patients complain of Stryker hip complications

Soon after these systems arrived to the marketplace, Stryker Orthopaedics began receiving a steady stream concerning reports. Though each system presents its own set of complications, all three shared reports of early failure requiring hip revision surgery. The second surgery to remove and replace a failed hip implant is fraught with all the risks of any major surgery coupled with the added complications caused by the original implant.

Rejuvenate and ABG II problems lead to recall, lawsuits follow

In 2010, Stryker planned a 10-year study of Rejuvenate patients to review their progress following their hip replacement. Within just two years however, the company instead issued an Urgent Field Safety Notice warning surgeons  of the system’s tendency to cause metallosis and prompt the need for hip revision. Only months later, the company issued a voluntary recall of the devices, noting problems with the corrosion, fretting, and related complications.

Stryker hip replacement lawsuits regarding these systems often cite metallosis, or heavy metal poisoning. This complication occurs due to the metal components rubbing together at the modular neck junction which then releases metallic particles into the bloodstream and surrounding tissues which may lead to tissue necrosis. Some patients experience allergic reactions to the metallic debris, as well as bone damage, bone loss, and increased levels of cobalt and chromium in the blood.

The systems are also known to fail prematurely, necessitating revision surgery for many patients.  Like recipients of the Trident models, Rejuvnate and ABG II patients also have complained of premature loosening.

Rejuvenate and ABG II models share these common complaints:

• Significant joint pain
• Swelling
• Device fretting
• Device corrosion
• Bone fractures
• Infections
• Pseudotumors

Trident hip problems lead to recall, lawsuits

The FDA began to receive adverse event reports from patients with regard to Stryker’s Trident line as early as 2005. As the agency continued to receive numerous complaints detailing severe complications and early failure of the devices, they decided to investigate two of Stryker’s manufacturing plants, located in Cork, Ireland, and Mahwah, New Jersey. Subsequently, the FDA sent warning letters to the company detailing the problems found at those two plants.

The first warning letter is dated from 2007 and it involves numerous violations it found at the plant in Cork, Ireland. The plant was found to have violated the Current Good Manufacturing practices. The FDA found fault with the plant’s processes in manufacturing, packaging, and storing the devices.  Another warning letter, also dated from 2007, involves the plant in New Jersey. The FDA found evidence of Staph bacteria at the manufacturing plant, which could potentially contaminate the hip devices. This warning letter also informed Stryker Orthopaedics that the company was negligent in resolving complications with their hip implants, such as failure of the devices.

In 2008, Stryker Orthopaedics issued a voluntary recall for the Trident system. Many patients who had already received the Trident hip implant had to undergo potentially dangerous revision surgeries.

Plaintiffs who have filed Trident hip lawsuits tend to allege:

• Uneven wearing away of the bone
• Reduced mobility
• Significant pain of the joint
• Inflammation of the joint
• Abnormal popping and squeaking noises from the joint
• Breaking off of components
• Bone fractures
• Loosening of the components
• Contamination of the components

Plaintiffs demand compensatory damages

Many of the Stryker hip lawsuits have been consolidated into coordinated proceedings for greater efficiency. On January 15, 2013, some of these lawsuits were consolidated into a multicounty litigation (MCL) proceeding in a New Jersey court under the Honorable Judge Brian R. Martinotti. As of November 18, 2013, the case list for these Rejuvenate and ABG II systems lawsuits included 553 complaints. Additional lawsuits are proceeding in a multidistrict litigation (MDL) in federal court in Minnesota.

The plaintiffs demand compensatory damages for their injuries and permanent disabilities, and they demand compensation for their medical expenses, rehabilitative care needs, pharmaceutical expenses, and lost wages. With the help of their Stryker hip lawyers, the plaintiffs demand that Stryker be held liable for allegedly failing to design and manufacture a safe product, and failing to warn them of the potential risks. Given the sheer number of patients who received Stryker hip implants, it is likely that additional lawsuits will continue to be filed.

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