MAUDE Adverse Event Report: DT MEDTECH, LLC HINTERMANN SERIES H2 TIBIAL SLIDE; TOTAL ANKLE REPLACEMENT

Model Number 321002

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Implant Pain (4561)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Reported reversion of h2 tibial slide, h2 tibial assembly and h2 poly assembly due to x-ray malalignment.Revision surgery was completed and patient outcome is successful.

Event Description

Revision surgery to replace h2 tibia slide.

• Brand Name: HINTERMANN SERIES H2 TIBIAL SLIDE
• Type of Device: TOTAL ANKLE REPLACEMENT
• Manufacturer (Section D): DT MEDTECH, LLC; 111 moffit street; mcminnville 37110
• Manufacturer Contact: dustin leavitt ; 111 moffitt street; mcminnville, TN 37110 ; 8017181353
• MDR Report Key: 11753644
• MDR Text Key: 248414237
• Report Number: 3012104767-2021-00001
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00+B0953218021
• UDI-Public: +B0953218021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 321002
• Device Catalogue Number: 321002
• Device Lot Number: AAAJM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Date Device Manufactured: 01/18/2019
• 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