FLASH: Stryker recalls pair of metal hip implants, halts global production

July 6, 2012 by MassDevice staff

Orthopedic devices maker Stryker recalls a pair of metal-on-metal hip implants and halts global production after discovering potential for "fretting and/or corrosion" that could cause pain, swelling and tissue damage.

hip ipmlant x-ray

Orthopedic devices giant Stryker (NYSE:SYK) announced recall of a pair of hip implants over concerns that the devices may be prone to "fretting and/or corrosion at or about the modular-neck junction," which may lead to pain, swelling and adverse reactions in surrounding tissue.

The recall affects the company's Rejuvenate Modular and ABG II modular-neck hip stems, and Stryker decided to terminate global production of the devices after discovering a potential trend in post-market surveillance data.

"While modular-neck stems provide surgeons with an option to correct certain aspects of a patient's anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action," hip reconstruction vice president and general manager Stuart Simpson said in prepared remarks.

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Modular neck stems allow physicians to more accurately reproduce a patient's natural hip geometry and "can facilitate femoral component insertion in more technically challenging surgical approaches," according to a Stryker report dated 2012.

However, the neck stems have also been associated with sensitivity arising from metal corrosion.

"Stryker Orthopaedics' decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance," according to a press release. "The post-market surveillance data may be predictive of a trend."

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