BIOMET HIP SYSTEM

Additional Manufacturer Narrative

(B)(4). D10: CAT# 110031012 LOT# 67075158. G2: FOREIGN ¿ EVENT OCCURRED IN AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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 APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO DISLOCATION. A NEW HEAD AND LINER WERE PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.