MAUDE Adverse Event Report: DT MEDTECH, A VILEX COMPANY HINTERMANN SERIES H3 TIBIAL COMPONENT; TIBIAL IMPLANT

Catalog Number 301202

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

Patient Problem Insufficient Information (4580)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

There were no explants from this surgical intervention, only debridement.

Event Description

On 1-november-2023, it was informed via email that a revision surgery would be planned for (b)(6) 2023 due to a post-operative fracture of the right medial malleolus.The joint was debrided and the implants were left intact.

• Brand Name: HINTERMANN SERIES H3 TIBIAL COMPONENT
• Type of Device: TIBIAL IMPLANT
• Manufacturer (Section D): DT MEDTECH, A VILEX COMPANY; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: 111 moffitt street; mcminnville, TN 37110 ; 8006808514
• MDR Report Key: 18242280
• MDR Text Key: 329431954
• Report Number: 3012104767-2023-00004
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 301202
• Device Lot Number: AABMC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2022
• 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