Stryker Rejuvenate and ABG II Hip Implant Systems Voluntary RecallJuly 6, 2012 | Category: DePuy Hip Implant Recall | Share
Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P.A. reports that Stryker Orthopedics abruptly recalled the Rejuvenate Modular and ABG II modular-neck hip stems on July 4, 2012. Some patients developed immunological responses, metallosis, significant pain, elevated serum levels of cobalt, allergic reactions and/or tissue necrosis. Even though the Stryker Rejuvenate Hip Implant is a ceramic on plastic bearing surface, the modular design requires the metal femoral neck to be inserted into the metal femoral stem. More than 60 adverse event reports are on file with the FDA's Manufacturer and User Facility Device Experience (MAUDE) adverse event reporting system.
Previously Stryker issued a letter - "URGENT: Field Safety Notice" which indicated "all known potential hazards" associated with the Rejuvenate Hip Implant and Stryker's efforts to mitigate and minimize patient risks. This letter was directed to surgeons, hospital risk managers and distributors. However, many hip implant patients and surgeons were unaware of this Field Safety Notice nor of the May 28, 2012 Canadian recall notice.
The FDA approved the Stryker Rejuvenate Modular Hip Implant System in April 2008. The system received FDA approval through the abbreviated 510(K) process (which does not require medical devices to be tested in advance on patients) because it was substantially equivalent to the design of Wright Medical Technology's Pro-Femur Total Hip Modular Neck System. This system has also been linked to patient injuries because of corrosion between the modular components. The Stryker Rejuvenate Modular Hip Implant System has been in use since 2009.
Unlike the DePuy ASR failed hips where the surgeon only removes and replaces the acetabular cup and the metal ball, patients with adverse affects from the Stryker Rejuvenate Modular Hip must undergo the removal of the femoral stem - the part of the device that is driven into the long bone in the thigh (femur). Once implanted these femoral stems are supposed to be permanent. If they are removed, there is risk of femoral fracture and the procedure is very traumatic.
If you or a loved one is experiencing problems from the Stryker's Rejuvenate or ABG II Hip Implant System or any medical device, please contact us at the Spivey Law Firm, Personal Injury Attorneys, P.A. specializing in personal injury and wrongful death.
Randall L. Spivey is a Board Certified Civil Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by less than 2 percent of Florida attorneys. He has handled over 1,500 personal injury and wrongful death cases throughout Florida. For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., at 239. 337.7483 or toll free at 1.888.477.4839, or by email to Randall@SpiveyLaw.com. Visit SpiveyLaw.com for more information. You can contact Spivey Law Firm, Personal Injury Attorneys, P.A. in Charlotte County at 941.764.7748 and in Collier County 239.793.7748.