28MM DIA COCR MOD HD -3MM NK

Additional Manufacturer Narrative

(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD D10: CAT# 13-104054 LOT# 155860 M/H RADIAL SOLID/APX SHL 54MM CAT# 11-104209 LOT# 138360 MLRY-HD LAT POR FMRL 9X150MM G2: FOREIGN - EVENT OCCURRED IN CANADA. 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 THE PATIENT UNDERWENT EXPLANTATION APPROXIMATELY 2 YEARS AND 5 MONTHS POST-IMPLANTATION DUE TO IMPLANT WEAR SYNOVITIS. THE INITIAL STEM AND CUP WERE STABLE AND LEFT INTACT. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATIONS. . ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.