Belt & Bruner, P.C., presents the following timeline of events for hip implant patients and their families who believe they may be suffering complications from the recalled Stryker Rejuvenate Modular-Neck Stem and ABG-II Modular-Neck Stem hip implants:
June 3, 2008
The U.S. Food and Drug Administration (FDA) approves the Stryker Rejuvenate modular-neck stem. According to Stryker, the Rejuvenate hip stem is designed to re-create the anatomy and biomechanics of individual patients. Stryker claims the Rejuvenate hip stem provides enhanced stability, proven modularity and intra-operative flexibility.
Stryker begins marketing the Rejuvenate Modular Primary Hip System.
November 4, 2009
The FDA approves the Stryker ABG-II modular-neck stem. Stryker markets the Rejuvenate and ABG-II products as a new generation of stems. The company targets a younger demographic. Stryker touts the devices as “high performance” in terms of corrosion resistance and improved fatigue strength.
Stryker issues an “Urgent Field Safety Notice” to surgeons – reiterating the technique for implantation and identifying a less than 1 percent failure rate due to metallosis between the neck and stem morse taper junction. Stryker does not notify consumers of any problems.
Stryker issues another “Urgent Field Safety Notice” to surgeons and hospitals in the U.S. for the two hip replacement systems. The alert lists the potential hazards in these devices, including
“excessive metal debris and/or ion generation” caused by “fretting and/or corrosion at or about the modular neck junction,” which “may lead to increased metal ion generation in the surrounding joint space.”
Stryker publishes a report stating mechanical problems with the modular-neck stems. Stryker says these stems have the potential to cause metal toxicity problems similar to those experienced by some patients with metal-on-metal hip implants.
May 28, 2012
The Canadian equivalent of the FDA announces that the Stryker Rejuvenate is being recalled.
July 6, 2012
Stryker voluntarily recalls its Rejuvenate and ABG-II modular neck systems from the U.S. market. Stryker also ceases global production and sale of these devices. By this time, the FDA has received more than 45 adverse event reports of metal toxicity requiring revision surgery.
Stryker urges surgeons to send letters to clients notifying them of these recalls and encouraging patients to contact Stryker.
Contact a Lawyer to Discuss Your Recalled Stryker Hip Implant Case
The lawyers of the Belt & Bruner, P.C., have been closely monitoring developments involving the recalled Stryker hip implants and are now reviewing claims of patients and families who may have been harmed by these medical devices.
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