PROFEMUR® MODULAR FEMORAL NECK

Description of Event or Problem

ALLEGEDLY, PATIENT AT THE AGE OF 37, RECEIVED THE SUBJECT COMPONENTS DURING AN INDEX THA ON 2005 DUE TO CONSTRUCTION TYPE ACCIDENT. ON (B)(6) 2023, WHILE SLEEPING IN HIS SLEEPER COMPARTMENT OF HIS CAR HAULER TRUCK, PATIENT SUFFERED A FRACTURE OF THE MODULAR NECK STEM JUNCTION. AS WE HAVE ROLLING OVER WHILE SLEEPING. AFTER THE FRACTURE PATIENT WAS TRANSPORTED TO THE HOSPITAL. DOCTOR PERFORMED A TROCHANTERIC OSTEOTOMY TO REMOVE THE STEM AN IMPLANT REVISION COMPONENTS. PATIENT WAS DISCHARGED AFTER BEING IN HOSPITAL FOR FOUR DAYS. AT THE TIME OF REVISION SURGERY PATIENT WAS 55-YEAR-OLD. HE WAS ROLLING OVER IN BED AND HAD A PAIN AND A SPASM TYPE SENSATION HE WAS TAKEN TO THE EMERGENCY DEPARTMENT AND X-RAYS SHOWED A GROSS TRUNNION FAILURE. PATIENT WAS PERFORMED TO REVISION SURGERY WHERE WAS ABLE TO EXPOSE THE ACETABULUM REMOVE THE TRUNNION WITH THE HEAD ATTACHED. THE TRUNNION HAD GROSSLY FAILED MID MORSE. THEN BEGAN USING PENCIL-TIP BUR AND FLEXIBLE OSTEOTOMES AS WELL AS STACKED K WIRES TO TRY AND FREE UP THE FEMORAL COMPONENT FROM THE TOP. AFTER ABOUT 25 MINUTES, THIS WAS UNSUCCESSFUL PARTICULARLY BECAUSE I HAD NOTHING TO GRAB ONTO TO BACK SLAP THE STEM AND SO I MADE THE DECISION TO DO AN EXTENDED TROCHANTERIC OSTEOTOMY. EVENTUALLY I WAS ABLE TO USE A VICE GRIP TO BACK SLAP THE STEM OUT. THE ACETABULUM WAS NOTED TO BE FAIRLY FLAT HOWEVER ON THE PREOPERATIVE CT SCAN I NOTED LACK OF POSTERIOR. I NOTED LACK OF POSTERIOR WALL BONE AND SO MY GOAL WAS TO PRESERVE THE COMPONENT. AS THE HIP SYSTEM WAS NO LONGER BEING MANUFACTURED, I DID NOT HAVE ANY EXTRACTION TOOLS AND SO I TRIED IT FIRST TO VIBRATE OUT. I ULTIMATELY USED AN OSTEOTOME AND BROKE THROUGH THE JUXTA POLAR REGION WHICH WAS THINNER. THIS CREATED SOME LARGE CERAMIC DEBRIS BUT WAS ABLE TO BE REMOVED IN ITS ENTIRETY. SATISFIED WITH MY TRAILING, I THEN REMOVED THE TRIAL PROXIMAL BODY FROM THE FEMUR COPIOUSLY IRRIGATED THE WOUND INCLUDING WITH LRRISEPT AND I CEMENTED IN A 45 MM SMITH & NEPHEW POLAR DUAL MOBILITY LINER THOROUGHLY MATCH THE VERSION OF THE CUP. I THEN PLACED MY FINAL PROXIMAL BODY ON THE FEMUR REDUCED THE HIP NOTING GOOD RESTORATION OF LEG LENGTH OFFSET AND GOOD STABILITY. THERE IS NO IMPINGEMENT WITH EXTENSION EXTERNAL ROTATION OR FLEXION INTERNAL ROTATION NO SUBLUXATION OR DISLOCATION. I THEN IRRIGATED YET AGAIN I CLOSED THE TENSOR GLUTEAL FASCIA WITH A RUNNING. PRODUCTS NOT REVISED: PART ID: 36510062, LINEAGE® PC QUAD HEMI STD, LOT: 105210552, QTY: 1. PART ID: 18080300, CANCELLOUS 6.5MM SELF-TAPPING, LOT: 01464783, QTY: 1. PART ID: 18080304, CANCELLOUS SELF-TAPPING 6.5MM, LOT: 05346386, QTY: 1.

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.