FDA Adverse Event
Injury
Summary report: N
TRILOGY
MDR report key: 24052200
·
Received January 13, 2026
Report
- Report Number
- 0001822565-2026-00148
- Event Type
- Injury
- Date Received
- January 13, 2026
- Date of Event
- February 20, 2024
- Report Date
- May 18, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K934765
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). D10: CAT# 00877703203 LOT# 3120605 BIOLOX® OPTION, HEAD. G2: FOREIGN ¿ CANADA. 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 · 0
IT WAS REPORTED THAT APPROXIMATELY NINE MONTHS POST-HIP SURGERY, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO GREATER TROCHANTER FRACTURE AND ABDUCTOR DEFICIENCY, A LARGE TEAR WAS NOTED. DURING THE PROCEDURE, THERE WAS TRUNNIONOSIS ON THE STEM TRUNNION. THE CUP AND STEM WERE RETAINED AND A CONSTRAINED LINER PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542375 | TRILOGY | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | 61790431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |