HXPE LINER CONSTRAINED MM 36

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION FOLLOWING A TOTAL FEMORAL REPLACEMENT AND UNDERWENT REVISION APPROXIMATELY SIX WEEKS POST-IMPLANTATION; THE TOTAL FEMUR PROXIMAL BODY WAS CHANGED TO INCREASE LEG LENGTH AND OFFSET, AND THE CONSTRAINED LINER WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.