Following the Stryker hip recall in July, 2012, many of those with a Rejuvenate hip device had unanswered questions. As many as 20,000 patients received a Stryker Rejuvenate; the first lawsuit against Stryker was filed less than a month after the recall was announced. The lawsuits now number in the hundreds, with many more expected. Many believe the Stryker cases could balloon into one of the biggest mass tort cases in the country.
If you have a Stryker Rejuvenate metal hip implant you may well wonder whether you could develop Stryker hip metallosis or chromium and cobalt poisoning, and whether you should speak to a Stryker hip recall lawyer. You may also wonder when Stryker first became aware of the issues associated with the Rejuvenate, and whether that knowledge could have saved you—and thousands of others—from the problems associated with the Stryker Rejuvenate. So is the Rejuvenate really that bad, or has the media frenzy following the recall made the damages seem worse than they really are?
Early Stryker Problems
As early as July of 2010, (after the Rejuvenate was approved by the FDA in 2009), one surgeon sent an alert to Stryker which noted the Rejuvenate hip implant suffered “fretting at stem/neck junction and tissue degradation.” A few months later, another orthopedic surgeon alerted Stryker that one of his patients showed evidence of corrosion at the modular junction of the Stryker Rejuvenate.
In January, 2011, yet another surgeon told Stryker that a removed Rejuvenate hip implant had areas of corrosion resembling black rust. There were at least seven additional reports from orthopedic surgeons to Stryker prior to the recall, with one of those reporting a patient with “massive metallosis” after implantation with a Stryker Rejuvenate hip implant. All of these surgeons expressed great concern regarding these Stryker Rejuvenate issues, yet it was not until almost two years later that the Stryker recall was issued.
Stryker Field Safety Notification
By April, 2012, Stryker issued an Urgent Field Safety Notification which read more like a legal document than a serious effort to provide medical professionals with safety information which would protect those already implanted with a Stryker Rejuvenate as well as those contemplating such a surgical procedure. The safety notification stated those with a Stryker Rejuvenate could find their implant suffered fretting and corrosion at the neck junction, leading to the release of cobalt and chromium ions into the body.
While admitting there could be issues related to the Rejuvenate, Stryker claimed fretting and corrosion at the modular neck junction was a “rare occurrence,” with less than 1% of patients experiencing such issues. The notification also indicated that instances of metallosis, tissue and bone necrosis, pain and osteolysis could be due to an unusual metal sensitivity in a patient or even diabetes or infection in the patient. Problems with the Stryker Rejuvenate were also blamed on the surgeons who implanted the device incorrectly as well as the individual patient’s weight and prior health conditions.
What are the Lawsuits Against Stryker Claiming?
Some of the claims against Stryker include: design negligence, deceptive sales and marketing practices, false claims that the Rejuvenate was a safe alternative to metal-on-metal bearing devices and that the Rejuvenate was a good fit for younger, more active patients, and a failure by Stryker to act on early reports of problems associated with the device. Further, Stryker failed to warn patients about the potential for heavy metal poisoning and continued selling the Rejuvenate long after they were aware that the titanium stem performed poorly with the cobalt and chromium neck. Many questions remain regarding the Stryker Rejuvenate and the extent of the damage done by the device; speaking with a Stryker hip recall lawyer could be beneficial.