MAUDE Adverse Event Report: VILEX, LLC HINTERMANN SERIES H2; H2 TIBIAL ASSEMBLY

Model Number	HT-32802
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: HINTERMANN SERIES H2
• Common Device Name: H2 TIBIAL ASSEMBLY
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: emily womack ; 111 moffitt street; mcminnville, TN 37110 ; 8005215002
• MDR Report Key: 24714918
• Report Number: 1051526-2026-00004
• Device Sequence Number: 14884631
• Product Code: HSN
• UDI-Device Identifier: 00841731142139
• UDI-Public: 00841731142139
• Combination Product (Y/N): N
• PMA/510(K) Number: K240475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HT-32802
• Device Catalogue Number: HT-32802
• Device Lot Number: LV030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown