OTTO BOCK AXTION® PROSTHETIC FOOT

Description of Event or Problem

THE END-USER REPORTED HE WAS PERFORMING NORMAL HOUSEHOLD DUTIES WHEN THE PYRAMID FAILURE OCCURRED ON HIS AXTION FOOT. NO FALL OR INJURY OCCURRED WITH RESPECT TO THIS SPECIFIC REPORTED PYRAMID FAILURE. THE END-USER'S FOOT REMAINED WITHIN THE INTENDED USE-LIFE OF THE PRODUCT AND THE FOOT WAS BEING USED WITHIN THE DESIGNATED INDICATIONS. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT WILL BE REPORTED AS AN MDR SINCE THIS CONFIRMED DEVICE FAILURE IS KNOWN TO HAVE THE POTENTIAL TO CAUSE SERIOUS INJURY.