Hintermann Series H2 HT-32802Recalls & reported problems
Vilex LLC · Hintermann Series H2 Tibia Implant, Sz2 Left, 7mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841731142139), received between Mar 30, 2026 and Mar 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Defective Component
VILEX BECAME AWARE OF AN EVENT INVOLVING THE H2 TOTAL ANKLE IMPLANT COMPONENTS ON (B)(6) 2026. THE PURPOSE OF THE EVENT SURGERY WAS TO REVISE AN EXISTING TOTAL ANKLE REPLACEMENT SYSTEM FROM A DIFFERENT MANUFACTURER. REP STATES THE TIBIAL SLIDE LOCKING MECHANISM, PACKAGED WITH THE TIBIAL COMPONENT, WAS INSERTED IN THE CORRECT ORIENTATION AND FAILED TO LOCK THE INSERTED POLY COMPONENT IMPLANT. ONCE IT WAS DETERMINED THAT THE LOCK WOULD NOT ENGAGE WITH THE POLY COMPONENT, THE TIBIAL AND POLY COMPONENTS WERE REMOVED, AND A NEW TIBIAL COMPONENT ASSEMBLY AND POLY ASSEMBLY WERE INSERTED. TOTAL DELAY IN SURGERY APPROXIMATELY 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715758 ↗MalfunctionMar 30, 2026Defective Component
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714918 ↗
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- Vantage 350-21-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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