Though they were pulled from the market nearly five year’s ago, Stryker’s Rejuvenate and ABG II hip replacements continue to adversely impact the company’s bottom line. Fourth quarter profits at the medical device maker were down 2.3% compared to last year, partly due to the charge related to the 2012 Rejuvenate and ABG II hip recall.
Stryker removed Rejuvenate and ABG II Modular-Neck Hip Stems from the global market in July 2012, due to a high rate of fretting and corrosion at the modular-neck junction. The recall prompted thousands of Rejuvenate and ABG II hip recipients to file suit against the company for failures and revision surgeries allegedly related to the issue.
In November 2014, Stryker agreed to pay $1.43 billion to settle a large portion of the claims. Under the terms of the initial Rejuvenate and ABG II settlement agreement, plaintiffs who had undergone revision for a recall-related reason prior to November 3, 2014 were eligible for gross base awards of $300,000 per failed implant. However, that amount was subject to deductions and enhancements based on the factors unique to each claim, such additional compensation for those who suffered complications during revision surgery. The settlement also provided compensation to Rejuvenate and ABG II recipients who were in need of revision but were medically unable to undergo the procedure.
Late last year, the Stryker hip settlement program was expanded to include Rejuvenate and ABG II hip recipients who underwent hip revision surgery due to a recall-related reason prior to December 19, 2016.
Unfortunately Stryker’s hip implant woes did not end with the Rejuvenate and ABG II recall. Last August, the company recalled certain LFIT V40 Femoral Heads after the devices were tied to a high number of taper lock failures, which can lead to fractures, excessive levels of metallic debris, separation of the femoral head from the stem and other serious issues. The affected LFIT V40 Femoral Heads are made of a cobalt and chromium alloy and are used in combination with a number of Stryker’s modular hip implants, including:
A number of lawsuits involving the Stryker LFIT V40 Femoral Head recall have since been filed in U.S. courts. Plaintiffs in these cases recently requested that all such-federal claims be centralized in a single U.S. District Court for coordinated pretrial proceedings.