TRIDENT 10 DEG X3 INSERT 36E

Additional Manufacturer Narrative

REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR REVISION DUE TO DISLOCATION. PATIENT'S LEFT HIP REVISED DUE TO DISLOCATION. PATIENT HAD PREVIOUSLY BEEN REVISED FOR HO REMOVAL ONLY, AND THEY BEGAN DISLOCATING AFTER THAT PROCEDURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.