REMEDY SPECTRUM GV HIP SPACER

Additional Manufacturer Narrative

THE FEMORAL FRACTURE SEEN ON THE POST-OP X-RAY CONTRIBUTED TO THE DISASSOCIATION OF THE SPACER HEAD FROM THE STEM. IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT BE TRUSTED TO FOLLOW PHYSICIAN ORDERS SO IT IS POSSIBLE THAT THE PATIENT WAS NOT USING MOBILITY ASSIST DEVICE AS REQUIRED BY THE LABELING.

Description of Event or Problem

THE PATIENT HAD A HIP SPACER IMPLANTED ON (B)(6) 2025 AS PART OF A TWO-STAGE SURGERY TO ADDRESS THE PATIENT'S PRIMARY JOINT INFECTION. POST OPERATIVE IMAGES TAKEN ON (B)(6) 2025 SHOW A BONE FRACTURE IN THE FEMUR THAT IS ASSUMED TO HAVE TAKEN PLACE INTRA-OPERATIVELY DURING EXPLANTATION OF THE PREVIOUS DEVICE AND THE SPACER IMPLANTATION. POST OPERATIVELY THE FEMORAL FRACTURE PROPAGATED ONCE PATIENT WEIGHT WAS APPLIED AND THE SPACER HEAD DISASSOCIATED FROM THE SPACER STEM. ON (B)(6) 2025, THE PATIENT WAS TAKEN BACK TO SURGERY AND REVISED WITH A GIRDLESTONE AS THE PATIENT WAS STILL INFECTED (CULTURE POSITIVE).