On July 4, 2012, Stryker posted on its website a national recall of its Rejuvenate and ADM hip implant systems. It’s obvious that Stryker has received far too many reports of shockingly premature failures of its hip implant.
Typically, medical device manufacturers don’t recall a product unless they are convinced that the FDA is going to force them to do so. The far more typical action is to silently stop selling the device under the guise of “moving in a different direction.”
Here, however, Stryker simply had no choice. Clients I have spoken with relate that their surgeons have been on the phone “screaming” at Stryker about the devices’ performance. One client said his doctor had been on the phone with the president of Stryker.
Currently there are over 60 adverse event reports filed with the FDA’s MAUDE incident reporting system. That number has been climbing exponentially since the beginning of 2012.
These devices are supposed to last fifteen to twenty years. When they fail in huge numbers in less than two years post-implant, there is a serious problem.
As part of its market approval, Stryker agreed to perform a prospective study of the device. I’m sure the data that had been collected to date was not flattering but only discovery in the likely Stryker Rejuvenate hip implant failure cases will tell.
We at Searcy Denney have been following the Rejuvenate story for some time. Our experts have determined the failure mechanism for the device. We would be pleased to provide anyone concerned about their Stryker hip a free, confidential consultation.