MAUDE Adverse Event Report: DT MEDTECH, A VILEX COMPANY HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT

Model Number 301204

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/26/2023

Event Type  Injury  

Event Description

Patient was revised after an infection was diagnosed.

Manufacturer Narrative

Event also documented in 3012104767-2023-000001 and 3012104767-2023-000003.

• Brand Name: HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT
• Type of Device: ANKLE
• Manufacturer (Section D): DT MEDTECH, A VILEX COMPANY; 111 moffitt street; mcminnville TN 37110
• Manufacturer (Section G): DT MEDTECH, A VILEX COMPANY; 111 moffitt street; mcminnvill TN 37110
• MDR Report Key: 17206182
• MDR Text Key: 317909151
• Report Number: 3012104767-2023-00002
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 301204
• Device Catalogue Number: 301204
• Device Lot Number: AABMF
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male