CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ?INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED FOR GENERAL INSTRUMENTS.? DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.
D
Patient 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE G7 INSERTER THREADS FRACTURED DURING IMPACTION OF INSERTING THE CUP. THE CUP WAS WELL FIXED SO THE SURGEON DECIDED TO LEAVE IT; THE THREADS REMAINED IN THE CUP. THERE WAS NO DELAY IN PROCEDURE. THE SURGEON USED A FACE PLATE IMPACTOR TO COMPLETE THE PROCEDURE.
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
N
Patient 1
EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF RETURNED DEVICE FOUND THE ACETABULAR INSERTER?S THREADS HAD FRACTURED AS STATED IN THE COMPLAINT. PRODUCT LIKELY FAILED DUE TO MISUSE BY PRODUCT BEING PUT THROUGH BENDING OVERLOAD FORCE.