TRIDENT 0 DEG X3 INSERT 36D

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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT # DEVICE NAME; LOT# 18-3605 DELTA C-TAPER HEAD 36MM +5; (B)(4). 17-0000E TI SLEEVE FOR ALUMINA HEAD; X35811 7030-6525 6.5MM LOW PROFILE HEX SCREW 25MM; R25H 702-04-48D TRIDENTII TRITANIUM CLUSTER48D; (B)(4) 7000-6604 HIGH INSIGNIA COLLARED HIP STEM; (B)(4). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: LEFT HIP EXPLANT TO GIRDLESTONE OF AN INFECTED PATIENT.