Wednesday, July 11, 2012

Stryker recalls modular neck-stem devices attaching to artificial hips.


Stryker recalls modular neck-stem devices attaching to artificial hips.

The Boston Business Journal (7/10, Donnelly, Subscription Publication) reported, "Stryker Orthopaedics has voluntarily recalled two brands of devices used in conjunction with artificial hips in hip replacement surgeries, according to the US Food and Drug Administration website." To date, "there have been at least 45 adverse event reports from patients who say the devices caused pain and/or tissue swelling." This week, Stryker said that "it would remove Rejuvenate and ABG II modular-neck stems, which attach to artificial hips, from the market and cease global distribution."
        The modular neck-stem devices were recalled "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)," Medscape (7/11, Hitt) reports. "The FDA posted the company's press release, dated July 6." Stryker "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." 

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