Wednesday, September 26, 2012

September Stryker Rejunivate Recall News

On May 28, 2012, Health Canada informed that Stryker Rejuvenate was being recalled. The recall at that time affected only Rejuvenate devices sold in Canada and was based on a reported rate of less than one percent for revisions associated with the Rejuvenate. So far, no such Stryker recall has been announced in the US.

In July 2012, Stryker recalled its Rejuvenate and ABG II modular-neck stems from the market. The products were recalled according to reports of fretting and corrosion. According to some reports, the FDA received two adverse events linked to the recalled devices, including one in which the device was removed.

Here is the FDA notice:

Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.
"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," said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.
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. The post-market surveillance data may be predictive of a trend. "Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data," said Simpson.
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.

The Stryker Rejuvenate hip implant uses a ceramic component. This is used as an alternative to the metal-on-metal devices. It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion. 

Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possible—because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design—the Stryker hip device has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose.