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Eric T. Chaffin
Eric T. Chaffin
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What Makes a Metal-on-Metal Implant? Stryker Recall Expands Definition

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During the recent FDA panel two-day meeting on metal-on-metal implants, the 18 experts evaluated safety issues associated with such implants as the DePuy ASR, DePuy Pinnacle, Zimmer Durom Cup, Biomet M2a Magnum, and the like. All these implants involve all-metal components that can cause injuries to their users. The Stryker components can rub against one another during normal wear and tear, shedding metallic debris into surrounding tissues and potentially into the bloodstream.

The recent Stryker Rejuvenate recall, however, announced on July 4, 2012, has expanded the definition of the metal-on-metal hip. The Stryker Rejuvenate and Stryker ABG II modular-neck hip systems, both included in the recall, do not match a metal ball with a metal socket, like other metal-on-metal implants do. They do, however, involve a metal neck inside a metal stem—a two-part modular-neck system that has proven to increase the risk of metal poisoning perhaps as much as the metal ball and socket designs do.

Reports of Metal Poisoning Leads to Recall

According to the Stryker Orthopedics website, the company initiated the voluntary recall because of the potential risks associated with modular-neck stems, including the potential for fretting and/or corrosion around the modular-neck junction. Such corrosion can result in tissue reactions, pain, and swelling. According to the company, the recall is due to “a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.”

Unlike other hip systems that have a one-piece, fixed femoral stem, the Stryker devices have a two-part system that consists of the stem and the neck. The design was intended to give surgeons more options in creating a more anatomically correct hip joint. Post-marketing reports, however, indicated that once implanted in patients, the stem and neck could wear against one another, shedding metallic debris into the surrounding tissues. Resulting complications can include pseudotumors (pockets of swelling), tissue damage and death, bone damage and bone loss, significant pain, and premature hip failure.

A Series of Events Indicate Increasing Problems

The Stryker Rejuvenate recall is a culminating step in a series of events that indicated problems with these devices were happening far too frequently. To date the FDA has received over 60 adverse event reports related to the devices, with one surgeon indicating in March 2012 that six of his patients had developed metal sensitivity not long after being implanted with the Rejuvenate device. Other reports have been of a similar nature, leading the company to release a letter to distributors and surgeons in April 2012 warning about the risk of metallosis.

In May 2012, Health Canada announced a Stryker Rejuvenate recall, but the company indicated it intended to simply revise and update instructions for use, not recall the devices as it has now done. The recent recall announcement, however, may indicate that Stryker Orthopedics has intentions to stop sales worldwide.

Those patients injured by the Stryker Rejuvenate and ABG II systems may soon be coming forward to file a Stryker Rejuvenate lawsuit. Since the Rejuvenate was launched only three years ago, it's likely that several patients are only now beginning to experience complications related to metal poisoning, and reports of increasing revision surgeries may be forthcoming throughout the rest of the year.