IT IS REPORTED THAT DURING SURGERY IN 2008, THE SURGEON IMPLANTED THE SEGMENTAL DISTAL FEMUR BY USING A DIFFERENT TECHNIQUE. THE SEGMENTAL SET SCREW PORTION OF THE SEGMENTAL DISTAL FEMUR ASSEMBLY WAS THEN THREADED AND TIGHTENED INTO THE OPPOSITE SIDE (FROM THE SIDE THAT THE HINGE PIN WAS INSERTED) OF THE SEGMENTAL DISTAL FEMUR IMPLANT, INSTEAD OF BEHIND THE THREADED PORTION OF THE HINGE PIN AS INDICATED IN THE SEGMENTAL SURGICAL TECHNIQUE. DURING REVISION SURGERY, IT WAS NOTED THAT THE FEMORAL COMPONENT WAS ROTATING FREELY BECAUSE THERE WAS TOO MUCH LAXITY IN THE FLEXION/EXTENSION GAPS. THE DEVICE WAS REVISED, WHERE A NEW POLYETHYLENE INSERT WAS IMPLANTED WHICH RESOLVED THE ISSUE. EXPLANT DATE IS UNKNOWN.
N
Patient 1
DEVICE WAS IMPLANTED USING A DIFFERENT SURGICAL TECHNIQUE THAN THAT RECOMMENDED IN THE ZIMMER SEGMENTAL SYSTEM SURGICAL TECHNIQUE. THE STANDARD ZIMMER SEGMENTAL SYSTEM SURGICAL TECHNIQUE INDICATES TO "INSERT THE SEGMENTAL HINGE PIN SET SCREW ON THE SAME SIDE AS THE HINGE PIN," SHOWS THIS ORIENTATION OF THE FEMORAL ASSEMBLY WITH THE SET SCREW INSERTED BEHIND THE THREADED PORTION OF THE HINGE PIN. THE STANDARD TECHNIQUE WAS DEVIATED FROM BY THE SURGEON BY PLACING THE SET SCREW ON THE CONTRALATERAL SIDE OF THE IMPLANT. VERIFICATION TESTING OF THIS DEVICE WAS FOR AN ASSEMBLY WITH THE SET SCREW INSERTED ON THE SAME SIDE AS THE HINGE PIN, THUS THE CONFIGURATION IMPLANTED IN THIS COMPLAINT WAS NOT TESTED. THEREFORE, IT IS AN ISSUE OF THE SURGICAL TECHNIQUE NOT BEING FOLLOWED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.