FDA Adverse Event
Injury
Summary report: N
HINTERMANN SERIES H3
MDR report key: 23064052
·
Received September 16, 2025
Report
- Report Number
- 3012104767-2025-00001
- Event Type
- Injury
- Date Received
- September 16, 2025
- Date of Event
- April 22, 2024
- Report Date
- September 15, 2025
- Manufacturer
- DT MEDTECH, LLC
- Product Code
- NTG
- UDI-DI
- B0953004051
- PMA / PMN Number
- P160036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE REVISED DUE TO POST-OPERATIVE INFECTION.
Description of Event or Problem · 0
REVISION SURGERY EVENT WAS DISCOVERED WHEN DATA ANALYSIS FOR POST-APPROVAL STUDY ENROLLMENT REPORT WAS BEING PERFORMED. IT WAS NOT REPORTED BY THE SITE ASA REVISION SURGERY AT THE TIME. PATIENT WAS TREATED SURGICALLY FOR A SECONDARY POST-OP ACUTE INFECTION WITH I&D, SYNOVECTOMY, AND POLY EXCHANGE ON (B)(6) 2024. PATIENT UNDERWENT AN ADDITIONAL REMOVAL SURGERY FOR THE SAME INFECTION ON (B)(6) 2024 (REF. MFR REPORT# 3012104767-2024-00002). MANUFACTURER WAS NOT NOTIFIED OF THE EVENT AT THE TIME OF SURGERY; NO EXPLANT WAS AVAILABLE FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2561320 | HINTERMANN SERIES H3 | TOTAL ANKLE REPLACEMENT | NTG | DT MEDTECH, LLC | 300405 | AABIV | B0953004051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |