Description of Event or Problem · 1
PATIENT UNDERWENT LEFT HIP NONCEMENTED BIPOLAR HEMIARTHROPLASTY FOR A COMPLETELY DISPLACED LEFT FEMORAL NECK FRACTURE. APPROXIMATELY 5 WEEKS LATER, THE PATIENT PRESENTED AGAIN TO THE HOSPITAL FOR LEFT HIP DISLOCATION AFTER A FALL SUSTAINED AT HOME 4 DAYS PRIOR. PATIENT REPORTED HEARING "HIP POP OUT WHEN SHE HAD FALLEN AND NO OTHER INJURY". THE PATIENT DID REQUIRE A REVISION TO A UNIPOLAR HEAD COMPONENT AND REDUCTION OF THE HIP. X-RAYS ON SECOND ADMISSION REVEALED THE LEFT HIP PROSTHESIS WAS DISLOCATED SUPERIORLY FROM THE ACETABULUM AND THE HEAD OF THE PROSTHESIS WAS DISLOCATED FROM THE STEM. NO BONY FRAGMENTATION WAS IDENTIFIED. THERE WAS NO INJURY TO THE PATIENT, THERE IS CONCERN THIS IS AN IMPLANT FAILURE.MANUFACTURER RESPONSE FOR FEMORAL HEAD IMPLANT, COBALT CHROME TAPER FEMORAL HEAD (PER SITE REPORTER).MANUFACTURER HAS REQUESTED DEVICE FOR EXAM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REPAIR OF DISLOCATED LEFT HIP HEMIARTHROPLASTY WITH BIPOLAR COMPONENT DISSOCIATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.