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	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• 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: 24715758
• Report Number: 1051526-2026-00003
• Device Sequence Number: 5677274
• Product Code: HSN
• UDI-Device Identifier: 00841731142139
• UDI-Public: 00841731142139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K240475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• 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