MAUDE Adverse Event Report: DT MEDTECH LLC HINTERMANN SERIES H3 TOTAL ANKLE - TALAR COMPONENT; COATED TALAR COMPONENT

Model Number 301113

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Laxity (4526)

Event Date 07/08/2021

Event Type  Injury  

Event Description

Patient ankle joint revision due to malalignment.Revised due to patient circumstance of severe flatfoot and ples planus valgus due to tendon laxity.

• Brand Name: HINTERMANN SERIES H3 TOTAL ANKLE - TALAR COMPONENT
• Type of Device: COATED TALAR COMPONENT
• Manufacturer (Section D): DT MEDTECH LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer (Section G): DT MEDTECH LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: 111 moffitt street; mcminnville, TN 37110
• MDR Report Key: 12263731
• MDR Text Key: 264702987
• Report Number: 3012104767-2021-00002
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: B0953011131
• UDI-Public: +B0953011131/$$7AAAKO/14D20240628D
• 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: distributor,foreign,other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: 301113
• Device Catalogue Number: 301113
• Device Lot Number: AAAKO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: 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: 64 YR