Description of Event or Problem · 1
APPROXIMATELY 3 MONTHS POST OPERATION OF IMPLANTATION OF THE FIXION INTERLOCKING PROXIMAL FEMUR NAIL IN A PT, THE CO LEARNT THAT THE HIP PEG IMPLANTED WITH THE NAIL (LAG SCREW) HAS FAILED AND THAT THE PT HAD TO UNDERGO ADD'L SURGERY (FOR BONE MARROW AND DBM INJECTION). AS PER THE PHYSICIAN THE NON-UNION SEEMS TO BE PERSISTENT AND THE FEMORAL NECK IS DRIFTING INTO VARUS. THE INFO WAS REC'D DURING A F/U CALL RELATING TO THE COMPLAINT, AS WAS ORIGINALLY REC'D ON 5/2002, APPROXIMATELY 6 WEEKS POST IMPLANTATION, DURING PARTIAL WEIGHT BEARING PHASE. AT THAT STAGE THE HIP PEG DISTAL TIP SEEMED TO BE SLIGHTLY BENT ON X-RAYS, BUT THE PEG WAS IN PLACE, AND SEEMED TO BE WELL POSITIONED. IT SHOULD BE NOTED THAT THE FLEXIBILITY OF THE DISTAL SECTION OF THE PEG ALLOWS FOR SLIGHT BENDING. BASED ON THE SAID INFO, AND AS AT THE TIME IT DID NOT SEEM THAT THE DEVICE CONTRIBUTED TO A SERIOUS INJURY OR WAS LIKELY TO CAUSE A SERIOUS INJURY THIS INCIDENT WAS NOT REGARDED AS AN MDR AT THE TIME OF THE INITIAL COMMUNICATION (5/2002 COMMUNICATION). BASED ON THE CURRENTLY AVAILABLE X-RAYS, AND AS THE PRODUCT IS STILL IMPLANTED IT IS HARD TO EVALUATE THE EXACT FAILURE AREA, AND THE EXACT NATURE OF THE FAILURE. IT SEEMS THAT THE FAILURE OF THE HIP PEG OCCURRED AT THE AREA WHERE THE DISTAL EXPLANDABLE BARS BEGIN (I.E., AT THE AREA WHERE THE BARS ARE ATTACHED TO THE RIGID PEG SHAFT). IT MAY BE THAT THIS FAILURE IS THE RESULT OF EXCESSIVE LOADS ACTING ON THAT AREA, PROBABLY DUE TO THE NATURE OF THE FRACTURE (A COMMINATED BASE OF FEMUR NECK FRACTURE).