August 07, 2015 - Stryker Orthopedics recalled two of their hip implant devices in July of 2012—the Rejuvenate and the ABGII. The recall was voluntary, after the FDA received a number of adverse event reports related to the devices. Patients were experiencing symptoms of Stryker hip metallosis and cobalt and chromium poisoning. Many of the devices failed entirely, requiring the patient to undergo Stryker hip revision surgery in which the defective device was removed, and replaced with a safer alternative. Thousands of lawsuits were filed against Stryker, and more than a dozen of the cases actually went to trial, decided in favor of the plaintiffs for undisclosed amounts.
Perhaps the results of those cases convinced Stryker to follow the lead of Johnson & Johnson and its subsidiary, DePuy, in crafting the Stryker Hip Settlement Agreement in November of 2014. It was a mandatory requirement that at least 94% of the qualified patients enroll in the program, and as of June 12, 2015, that number was at 95%. It is expected Stryker will begin sending out base award checks sometime this summer. Enhancement payments may be slower to arrive; at this point the enhancement payments are expected toward the end of 2015, or by the end of the first quarter of 2016.
In order to be eligible to participate in the Stryker Hip Settlement Agreement, each patient must meet the following criteria:
· Both the femoral stem and the neck of the ABGII or Rejuvenate must have been removed more than 180 days after initial implantation of the device, but prior to November 3, 2014.
· Both the original implantation of the recalled Stryker device as well as the revision surgery must occur in the United States or in a U.S. military hospital.
· The original Stryker hip device must have failed, necessitating revision surgery. That failure can be due to an elevated cobalt blood test, findings of tissue damage, either pathologic or intraoperative or an abnormal diagnostic scan.
· The patient’s revision surgery must not be solely due to one of the following: a trauma such as a fall, infection or recurrent dislocation.
· The original Stryker hip device must not have been removed because it broke.
The Stryker Hip Settlement Agreement also includes those patients who have a defective Rejuvenate or ABGII, but are unable to undergo a medically necessary revision surgery due to health issues. Those patients may be eligible to receive a one-time benefit under a program known as the Covered Unrevised Infirm Patient Program.
Patients who underwent revision surgery after the November 3, 2014, will not be included in the Stryker Hip Settlement Agreement; at present Stryker’s position is that those clients will continue with their Stryker hip lawsuit, and negotiations will ensue at a later date. It’s important that you not give up hope of Stryker hip monetary compensation if you suffered injuries due to a recalled Rejuvenate or ABGII but missed one or more deadlines. Speaking to a knowledgeable Stryker hip lawyer about the specifics of your case can help you determine what is your best course of action moving forward.