VIVACIT-E DM BEARING 28X44MM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 (ONE) MONTH LATER DUE TO PERIPROSTHETIC ACETABULAR FRACTURE AND RECURRENT DISLOCATION. DURING THE REVISION, A LARGE HEMATOMA WAS EVACUATED. THE PREVIOUS IMPLANT WAS REMOVED WITHOUT DIFFICULTY. THE ACETABULUM WAS IMPACTED WITH ALLOGRAFT, AND A DEFINITIVE CUP-CAGE CONSTRUCT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). D10: ITEM# 010000997 G7 SCREW 6.5MM X 20MM LOT# 7868289. ITEM# 010000999 G7 SCREW 6.5MM X 30MM LOT# 7633835. ITEM# 010000998 G7 SCREW 6.5MM X 25MM LOT# 7852535. ITEM# 010000999 G7 SCREW 6.5MM X 30MM LOT# 7633837. ITEM# 110010265 G7 OSSEOTI ACETABULAR SHELL LOT#65871897. G2 FOREIGN: AUSTRALIA THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.