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

Model Number 422805

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Revision surgery to replace h2 tibial assembly.

• Brand Name: HINTERMANN SERIES H2 TIBIAL ASSEMBLY
• Type of Device: TOTAL ANKLE REPLACEMENT
• Manufacturer (Section D): DT MEDTECH, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: dustin leavitt ; 111 moffitt street; mcminnville, TN 37110 ; 8017181353
• MDR Report Key: 10721998
• MDR Text Key: 212707774
• Report Number: 3012104767-2020-00002
• Device Sequence Number: 1
• Product Code: HSN
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 422805
• Device Catalogue Number: 422805
• Device Lot Number: AAAQX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• 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