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In the summer of 2012, Stryker implemented a voluntary recall of the Rejuvenate and ABG II hip replacement systems. They stated the devices presented “potential risks associated with modular-neck stems” that could lead to pain, swelling, tissue reactions, and premature hip implant failure.

Since then, a number of patients have filed Stryker Rejuvenate lawsuits in an attempt to recover damages for their injuries. In response to the increasing litigation, Stryker stated in October 2013 that it may spend between $700 million and $1.13 billion to resolve the lawsuits, in addition to the reimbursements it had already planned to injured patients.

Now, according to Long Island News, Stryker has agreed to settle four ABG II and Rejuvenate hip implant lawsuits in New Jersey. The settlements were for undisclosed sums.

FDA Warns of Metal-on-Metal Implants

In January 2013, the FDA released an updated safety communication concerning metal-on-metal hip implants. Unlike other implants made with metal and plastic or metal and ceramic, the metal-on-metal types contain all metal components that were initially believed to provide more durability. Scientific studies have revealed, however, that these types of devices are more prone to problems like metallosis, immobility, and premature loosening.

The FDA states, “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.” The metal ball and cup can wear against one another during walking, potentially shedding metal materials into the tissues of the surrounding joint. There, these ions can cause inflammation, swelling, pseudotumors, and bone loss. Over time, they can contribute to a loosening of the implant in the joint socket, requiring painful and risky revision surgery.

Modular Stem Proves Problematic

When Stryker first released the Rejuvenate and ABGII devices onto the market, they didn’t consider them to be the same as other metal-on-metal implants because they had ceramic components and did not pair a metal ball with a metal socket. The devices did, however, come with a two-piece femoral stem, designed to offer surgeons options when fitting the various anatomies of different patients. These two pieces were both made of metal alloys, and were found to sometimes wear against one another with use, shedding metallic debris into the body.

Currently, there are about 400 Stryker lawsuits pending in the U.S. District Court of Minnesota, where all federal Stryker lawsuits have been consolidated. In addition, there are about 500 cases pending in a New Jersey consolidation, called a “multicounty litigation” or “MCL.” Both consolidations are meant to help increase efficiency of pre-trial processes, though any case that isn’t settled will return to its original court of filing for trial.

Next Case Management Conference Scheduled

According to a Case Management Order released December 16, 2013, in the New Jersey Stryker MCL, additional mediations are scheduled to take place in January 2014. The next case management conference is scheduled for January 28, 2014 at 11:00 a.m. Preliminary discussion related to potential scheduling of bellwether trials is to occur at this conference.

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