In March 2010, DePuy first notified doctors in the United States of the high failure rate of the DePuy ASR Hip Implant system based upon the Australian Joint Replacement Registry data. However, DePuy did not issue a recall of the Depuy ASR Hip Implant device. Interestingly, months earlier, in late 2009, DePuy informed doctors that the company was discontinuing the sale of the DePuy ASR Hip Implant devices due to a decline in sales.
Although the ASR was approved for use by the FDA in 2005, it was cleared through a regulatory pathway that did not require it to undergo clinical trials.
