Why Did Stryker Wait to Recall Rejuvenate Hip Device?
On July 6, 2012, Stryker Orthopaedics announced that it was recalling certain hip device components, including the Rejuvenate. The Rejuvenate device is a modular-neck stem used in hip replacements. It is associated with corrosion and fretting, which can cause pain and swelling. The problems have forced some patients to undergo painful revision surgeries to remove the dangerous device.
My immediate response to this recall announcement was that Stryker should have taken this action long ago. Reports of problems with this device are not new. In fact, in April 2012, Stryker announced a recall of these devices in Canada. If the device was not safe in Canada, why did the company allow doctors to continue using it in the United States and throughout the world?
The company clearly had information that it understood called into question the safety of the device. When it became evident that the problems were serious enough to prompt a recall in Canada, the company immediately should have moved to suspend all sales of the device and initiate a global recall.