FDA Adverse Event
Malfunction
Summary report: N
HINTERMANN SERIES H2
MDR report key: 24714918
·
Received March 30, 2026
Report
- Report Number
- 1051526-2026-00004
- Event Type
- Malfunction
- Date Received
- March 30, 2026
- Date of Event
- November 21, 2025
- Report Date
- March 27, 2026
- Manufacturer
- VILEX, LLC
- Product Code
- HSN
- UDI-DI
- 00841731142139
- PMA / PMN Number
- K240475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DURING INVESTIGATION OF REPORTED COMPLAINT (B)(4) (REPORT NO. 1051526-2026-00003), THE FOLLOWING ADDITIONAL EVENT WAS IDENTIFIED. DURING AN H2 TOTAL ANKLE SURGERY, PERFORMED (B)(6) 2025, THE TIBIAL SLIDE LOCKING MECHANISM THAT WAS PACKAGED WITH THE TIBIAL IMPLANT FAILED TO LOCK THE POLY INLAY COMPONENT IN PLACE. THE LOCKING MECHANISM WAS REMOVED AND REPLACED WITH A NEW MECHANISM THAT SUCCESSFULLY LOCKED THE POLY INLAY INTO PLACE AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773121 | HINTERMANN SERIES H2 | H2 TIBIAL ASSEMBLY | HSN | VILEX, LLC | HT-32802 | LV030 | 00841731142139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |