TIMELINE OF EVENTS
June 3, 2008: FDA approved the Stryker Rejuvenate
modular-neck stem. According to Stryker, the Rejuvenate hip stem was designed
to re-create the anatomy and the biomechanics of individual patients. Stryker
claimed the Rejuvenate hip stem provided enhanced stability, proven modularity
and intra-operative flexibility.
February 2009: Stryker began marketing the Rejuvenate
Modular Primary Hip System.
November 4, 2009: FDA approved the Stryker ABG-II
modular-neck stem. Stryker marketed these two products as the new generation of
stems and targeted a younger demographic. Stryker touted them as “high
performance” in terms of corrosion resistance and improved fatigue strength.
February 2010: Stryker issued an “Urgent Field Safety
Notice” to surgeons – reiterating technique for implantation and identifying
less than 1% failure rate due to metallosis between the neck and stem morse
taper junction. Stryker failed to notify consumers of any problems.
April 2012: Stryker issued another “Urgent Field
Safety Notice” to surgeons and hospitals in the United States for the two hip
replacement systems. The alert listed 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.”
May 2012: Stryker publishes report stating mechanical
problems with the modular-neck stems. Stryker says these stems have the
potential to cause similar metal toxicity problems that some patients with
metal-on-metal hip implants have experienced.
May 28, 2012: The Canadian equivalent of the FDA
announced that the Stryker Rejuvenate was being recalled.
July 6, 2012: Stryker voluntarily recalled its
Rejuvenate and ABG-II modular neck system from the United States market.
Stryker also ceased global production and sale of these devices. By this time,
the FDA received more than 45 adverse event reports of metal toxicity requiring
revision surgery.
August 2012: Stryker urges surgeons to send letters to
clients notifying of these recalls and encouraging patients to contact Stryker.
