BICONTACT H PLASMAPORE 12/14 SIZE 15MM

Description of Event or Problem

AN ADVERSE EVENT WAS REPORTED INVOLVING THE AESCULAP KNEE IMPLANTS. SPECIFICALLY, IT WAS REPORTED THAT FOLLOWING HIP SURGERY IN 2017, THE PATIENT EXPERIENCED A FALL. SUBSEQUENT EVALUATION REPORTEDLY IDENTIFIED A FRACTURE OF THE IMPLANTED MEDICAL DEVICE. REVISION SURGERY IS REQUIRED. THE SURGERY WAS PERFORMED IN ARGENTINA, AT (B)(6) HOSPITAL, BUT THE PATIENT CURRENTLY LIVES AND IS IN (B)(6). THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).