TRILOGY
Received Jul 7, 2026 · Event occurred Jun 10, 2026
Report 0001822565-2026-02461 · MDR key 25731735
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
00875305401
Lot number
67477872
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
45 YR · Female
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN BRAZIL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE PLACING THE 52 MM CUP DURING AN INITIAL HIP PROCEDURE, THE LOWER POSTERIOR WALL OF THE ACETABULUM WAS BROKEN. THERE WAS NO GRIP ON IT, SO A LARGER CUP WAS NEEDED. THERE WAS A 40 MINUTE DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.