TRIDENT II TRITANIUM CLUSTER52E

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: REVISED A RIGHT HIP DUE TO THE CUP DISLODGING FROM THE ACETABULUM. THE HEAD, CUP, LINER WERE ALL REVISED. THE ORIGINAL LOW PROFILE SCREW SHEARED OFF WHEN THE CUP DISLODGED, SO A PORTION OF THE SCREW THEY KEPT IN THE ACETABULUM. IT WAS REVISED TO A CUP AND AUGMENT WITH SCREWS AND DUAL MOBILITY HEAD AND LINER.