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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