The orthopedic device manufacturer Stryker has recalled two modular-neck hip stems. The recall affects all lots of the Rejuvenate Modular and the ABG II modular-neck hip stems. Hip stems are attachments to artificial hip replacements that allow the device to better fit a patient’s anatomy.
According to the company, the recall was initiated due to the potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.
Your surgeon can tell you if you received a Rejuvenate Modular or ABG II modular-neck hip stem, or you may review your medical records for implant identification information.
According to Stryker, if you have symptoms of pain and/or swelling in or around your replaced hip, you should schedule an office visit with your surgeon and discuss your symptoms. If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you.
The company initiated the recall after post-market surveillance data showed that the fretting and corrosion risk “may be predictive of a trend,” according to an FDA statement.
“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. Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall.
The Stryker Rejuvenate hip implant is different from other hip replacement devices in the news recently because it is not a metal-on-metal hip replacement device. Instead, the Rejuvenate hip replacement device, which uses a ceramic component, was meant as an alternative to the metal-on-metal devices.
Heygood, Orr & Pearson is actively representing clients who have been injured as a result of defective hip implants. We have been and will be dedicating all resources necessary to pursuing these cases.
If you have been injured by a delinquent artificial joint manufacturer, contact Heygood, Orr & Pearson for a free case evaluation. You can reach us by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form on this site.