MalfunctionHSN
HINTERMANN SERIES H2
Received Mar 30, 2026 · Event occurred Nov 21, 2025
Report 1051526-2026-00004 · MDR key 24714918
Device
Generic name
H2 Tibial Assembly
Manufacturer
Vilex, LlcModel number
HT-32802Catalog number
HT-32802
Lot number
LV030
Product problems
- Defective Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.
Remedial action
- Replace