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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Stryker Recall of Modular-Neck Stems – Rejuvenate and ABG II Products

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Add another hip implant to the list of devices for which patients should be wary. Earlier this month, the medical device company Stryker issued a voluntary recall of its Rejuvenate and ABG II modular-neck stems, which are a component part of many of the company’s hip implant systems. These components are attachments to artificial hips that allow the implant to better fit a particular patient’s anatomy.

The global recall comes in response to post-market monitoring of their safety and effectiveness that revealed concerns about patient safety. Since the beginning of 2012 alone, there have been at least 45 adverse events reported to the FDA in relation to the Rejuvenate modular-neck stem. The company’s website states that the recall is motivated by the risks of “fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”

This issue of corrosion or fretting is the same issue that has plagued metal-on-metal hip implants and led to multiple recalls of those devices that are now resulting in massive litigation against the makers of the devices. The Stryker device is a component that can be used in conjunction with either metal or ceramic hip implants. But the component itself is a metal-on-metal modular junction. The friction of the moving parts—similar to metal-on-metal hip replacement devices—can cause toxic metal debris to enter the blood stream. When that happens, patients can experience pain, inflammation, swelling, tissue damage and even metallosis.

Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records. A dedicated patient call center can be reached at 1-888-317-0200 and additional information can be found at www.AboutStryker.com/ModularNeckStems