March 03, 2015 - The Stryker Rejuvenate and ABGII gained FDA approval in 2008 and 2009. Stryker did not start marketing the two hip devices in earnest until early 2010. Stryker claimed there would not be the same issues associated with the ABGII and the Rejuvenate due to the use of a ceramic, rather than a metal ball. Stryker also claimed that once the Rejuvenate or ABGII was implanted, it would last from 15-20 years. Stryker offered a variety of neck and stem pieces, allowing surgeons to custom-fit the device to the individual patient. The design was also believed to add anatomical stability as a result of the titanium femoral stem, which was believed to offer a more even load transfer.
Stryker’s glowing description of their new implants completely failed to address the problems later found with the devices and did not mention the neck portion which fits into the stem via a Morse taper junction. Despite the innovative design of Stryker’s new hip implants, patients began experiencing serious side effects related to the devices within months of implantation. The design which was supposed to offer longevity and safety to patients, seemingly failed to deliver on those promises. In April of 2012, Stryker issued an Urgent Field Safety Notification to hospitals and physicians, warning of the propensity of the implants to release an excessive amount of cobalt and chromium ions into the body as a result of fretting and corrosion at the neck juncture.
At this time, Stryker also noted that many of the current problems patients were experiencing were either due a poorly-placed implant or that patients who were overweight or had a prior medical condition were at fault. Stryker noted that many of the problems were due to inadequate locking or assembly of the Morse taper or that inadequate cleaning of the neck taper could be responsible for an increase in metal ion debris generation. Just a few short months later, in July, 2012, the recall of the Rejuvenate and ABGII was issued.
Stryker and the FDA’s 510(k) Approval Process
Both the Rejuvenate and the ABGII gained FDA approval through the controversial 510(k) approval process which requires the device only be substantially similar to another device already on the market. The Rejuvenate was approved based on its similarity to the Wright Profemur—which, at this point, has had hundreds of adverse event reports of its own. In fact, a 2008 Australian report claimed the Wright Profemur had a revision rate several times that of comparable hip implant devices. As early as July, 2010, several surgeons noted significant levels of fretting and corrosion at the stem/neck juncture of the Rejuvenate and ABGII. One surgeon noted what appeared to be “black rust,” when he removed a device from his patient.
Status of Stryker Lawsuits
Over 4,000 Stryker lawsuits were filed following the recall, with only a handful of those being settled over the past year through mediation. Stryker is currently offering a Stryker Master Settlement Agreement only to those patients who have undergone Stryker hip revision surgery. The base award is $300,000, subject to certain reductions, enhancements and caps, according to each patient’s individual circumstances. If you have a recalled Stryker hip implant, it can be helpful to speak to a knowledgeable Stryker hip attorney in order to determine what compensation you may be entitled to and to ensure your rights are protected.