Stryker Hip Implant Recalls
Metal-on-metal hip implants manufactured by Stryker Orthopedics have been at the center of multiple recalls over the past several years. The devices have been prone to failure at higher-than-usual rates, causing painful side-effects such as tissue damage, metallosis, and implant replacement.
Potential LFIT V40 Recall
Stryker’s LFIT V40 femoral head may be the next hip implant component to be recalled. The Stryker LFIT V40 femoral head, which has been used in conjunction with Stryker’s Accolade TMZF and Accolade 2 stems as well as Meridian and Citation stems, is prone to taper lock failures. The taper lock is the part of the implant connecting the femoral head to the femoral neck, and can lead to significant harm if the mechanism fails, such as extreme pain, problems walking, and revision surgery. Stryker received higher than anticipated complaints of taper lock failures for specific lots of certain sizes of LIFT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011, prompting the manufacturer to issue an “Urgent Medical Device Product Field Action Notification” to health care professionals worldwide on August 29, 2016.
Rejuvenate and ABG II Recall
In 2012, Stryker recalled its Rejuvenate Modular-Neck hip stem and ABG II Modular-Neck hip stem implants following evaluation of post-market data and an “Urgent Field Notice” issued to implant surgeons and hospital risk managers about the devices’ health hazards.
The neck components of the Rejuvenate and ABG II are made of chromium and cobalt. When the neck meets to the stem of the implant and wear against each other, metallic debris can shed into the bloodstream and damage the soft tissue surrounding the implant—often called metallosis. Painful complications have been suffered by thousands of Rejuvenate and ABG II implant recipients, often leading to tissue and bone death and early device failure.
In November 2014, however, Stryker announced a $1.4 billion settlement to compensate patients forced to replace their Rejuvenate and ABG II implants after the devices failed. Approximately 4,000 lawsuits alleging similar device failure claims were part of the settlement.
Stryker Accolade TMZF Recall
Another Stryker hip stem, the Accolade TMZF, caused similar problems. Stryker issued an “Urgent Product Recall” in 2009 due to of “product deviation,” as specific lots of the stem did not meet Stryker’s standards for tensile bond strength and crystallinity. The Accolade TMZF hip stem is made of titanium, prone to corroding and “fretting” when used with cobalt chromium femoral heads.