How the Stryker Rejuvenate and ABGII Gained FDA Approval
Both the Stryker Rejuvenate and the Stryker ABGII obtained FDA approval through a controversial process known as the 510(k). This approval process allows manufacturers of medical devices to secure a relatively quick approval based on the device being substantially similar to another device which is already on the market. Stryker Rejuvenate FDA approval came in 2008, based on the Wright Medical Profemur, which has had issues of its own. The Profemur has been found to have a higher-than-normal rate of fretting, corrosion and fracture.
Stryker ABGII FDA approval came in 2009, under the same program. At the time Stryker received FDA approval for the ABGII and the Rejuvenate, the company was told to complete a study of the outcomes of Rejuvenate modular hip implants. The clinical study began in 2010, evaluating subjects for absence of hip revision surgery at five years, and clinical outcomes for up to ten years after surgery. Because the recall occurred in 2012, it is unlikely this study will be completed.
When Stryker Rejuvenate Adverse Event Reports Began
The initial adverse event reports for the Stryker Rejuvenate and ABGII began shortly after Stryker began actively marketing the implants in 2010. In fact, in 2010, the FDA received over sixty adverse event reports involving a Rejuvenate or ABGII. By the end of 2011, that number had more than doubled, and by the first half of 2012, the number of adverse event reports had climbed to over 300. Other countries have also seen similar numbers of adverse event reports regarding the Stryker Rejuvenate and the Stryker ABGII.
The Australian Registry calculated a failure rate of as much as 8.1% in the first year after ABGII modular hip stem implantation, and reported in 2011 that of 164 implants, ten had already failed. Many surgeons submitted adverse reports on behalf of their patients, with some noting that what looked like “black rust” could be seen on removed implants. During the time, the Stryker Rejuvenate adverse event reports and the Stryker ABGII adverse event reports continued to rise.
What Was Contained in the Stryker Urgent Field Safety Notice?
In April, 2012, an Urgent Field Safety Notice was sent to hospitals and surgeons regarding problems associated with the ABGII and the Rejuvenate. This safety notification was believed by many to be a tactic meant to “dismiss and detract” At this time Stryker maintained the Rejuvenate and ABGII had only a one percent risk of failure. Stryker also claimed that there were other issues which had caused the problems with the Stryker ABGII and Rejuvenate, including surgeon error, the patients’ prior medical issues including metal hypersensitivity, diabetes, infections and obesity. Stryker did not make changes to their Surgical Technique Manual. Rather, the field safety notification stated a higher-than-normal risk of fretting and corrosion, leading to the generation of excess metal ion debris as well as possible hip failure.
How the Stryker Hip Implant Recall May Affect You
Shortly after the Stryker Urgent Field Safety Notice (July, 2012), Stryker issued a recall of the Rejuvenate and ABGII. The recall listed many of the same issues as the Stryker Urgent Field Safety Notice, however at this time Stryker declined to state a firm failure rate for the recalled hip implants. Those who have not yet experienced problems with a recalled Stryker hip implant could have a chance of developing problems in the future.