July 10, 2012 — Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems because of postmarketing data showing fretting and corrosion at the modular neck junction, according to an alert from the US Food and Drug Administration (FDA).
The FDA posted the company's press release, dated July 6, yesterday.
"Since 2007, there have been approximately 30,000 implantations globally to date combined for both product lines; approximately 20,000 implanted in North America and 10,000 primarily in Europe," Jeanine Guilfoyle, a spokesperson with Stryker, told Medscape Medical News. "The incidence of complications associated with modular neck stems is extremely low. As of June 2012, the reported rate of adverse local tissue reaction is less than 0.5% of patients with these modular-neck hip stem," she said.
"Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall," the alert states. The voluntary recall is specific to the Rejuvenate Modular and ABG II modular-neck stems only.
According to the manufacturer, risks associated with the product include the potential for fretting and/or corrosion at or around the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.
"Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis," the manufacturer notes.
The company states that patients who already have the implanted modular-neck stems should contact their surgeon only if they experience pain and/or swelling of the hip and should undergo revision surgery only if symptoms of pain and swelling at the local joint site are not attributable to other conditions such as aseptic loosening and periprosthetic sepsis.
Questions about the recall can be directed to a patient call center at 1-888-317-0200.
To report problems with these implanted modular-neck stems, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: Hip Replacement Parts Subject to Voluntary Recall - Medscape - Jul 10, 2012.
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