On July 6, 2012 Stryker Corporation voluntarily recalled its Rejuvenate and ABG II modular-neck hip stems.
Modular-neck hip stems are meant to correct certain aspects of a patent’s anatomy and hip biomechanics. Recent FDA adverse event reports, however, link the product has been associated with tissue reactions resulting in pain and/or swelling.
“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 the FDA received numerous adverse event reports. This data may be predictive of a trend.
Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.
This recall comes just a few months after Stryker themselves published a report in May that compares their product with the controversial metal on metal implants.
The recalled Stryker hip implant components are two-part modular-neck systems that consist of a metal neck inside a metal stem. According to the Stryker report entitled “Evaluation of painful total hip Replacements with Modular Metal Taper Junctions,” patients who have received these implants may suffer from the same types of reactions that have been seen in patients who have received implants where the ball and socket were entirely made of metal. Such reactions often result in “premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation,” the report said.
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.
Upon investigating the seriousness of this issue, it was discovered that this recall was definitely warranted as the FDA reports having received over 60 adverse event reports related to the recalled Stryker hip implant devices.
A dedicated patient call center can be reached at 1-888-317-0200 and additional information can be found at www.AboutStryker.com/ModularNeckStems.