MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number TIBIAL INSERT MB SZ 2 LT 6MM

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 5912352 - 350-01-02e - taluskappe 2, li.6410420 - 350-31-03 - tibiaplateau mobil 3, li.6330728 - 350-41-02 - tibia inlay mobil 6 mm, 2, li.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a patient, initial left ankle implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2024, approximately 2 years 11 months post the initial procedure.The surgeon had to revise the insert / inlay due to a breakage.No parts or pieces fell into the patient.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted device is available for return.No further information.

• Brand Name: VANTAGE
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18880310
• MDR Text Key: 337402573
• Report Number: 1038671-2024-00456
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIBIAL INSERT MB SZ 2 LT 6MM
• Device Catalogue Number: 350-41-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Date Device Manufactured: 12/05/2019
• 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