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. 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. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03948 / 03949).
D
Patient 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE CUP INSERTER BECAME MARRED UPON IMPACTION AND THE INNER LOCK BOLT BECAME CAPTURED INSIDE THE HANDLE. THE ENTRY HOLE WAS ALSO DISFIGURED AND THE INNER BOLT COULD NOT PASS FREELY. THE DISTAL THREAD ALSO BECAME DEFORMED DUE TO IMPACTION. THE INNER POLY WAS SEATED BY IMPACTION. THE INSERTER WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
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Patient 1
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
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Patient 1
EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. BASED ON DEVICE HISTORY RECORDS, THE PRODUCT WAS MADE TO PRINT AND CORRECT MATERIALS. HE THREADED INSERTER SHAFT CANNOT BE INSERTED INTO THE THROUGH HOLE OF THE HANDLE BODY DUE TO THE DAMAGE. INSTRUMENT LIKELY FAILED DUE TO EXCESSIVE IMPACTS TO THE STRIKE PLATE, WHICH DEFORMED MATERIAL AROUND THROUGH HOLE.