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

Catalog Number	350-23-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 72 yo male patient, who had their left ankle implanted, underwent a revision procedure.The tibial clip was found on a lateral x-ray to be coming out of the poly.The poly was exchanged with a new tibial clip.There were no surgical delays or device breakages 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 devices are available for return.No device images were available.No further information.This is 1 of 2 reports.
Additional Manufacturer Narrative
D10: (b)(6), 350-01-04 - talar implant sz 4 lt, (b)(6), 350-11-04 - tibial plate fb sz 4 lt, (b)(6), 351-50-00 - model tibia talus report, (b)(6), 351-90-21 - 3.5" pin pouch, (b)(6), 351-90-21 - 3.5" pin pouch, (b)(6), 351-90-22 - 2.5" pin.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.Upon receipt of additional information pertaining to this event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: VANTAGE
• Common Device Name: 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22801004
• Report Number: 1038671-2025-02754
• Device Sequence Number: 15691129
• Product Code: HSN
• UDI-Device Identifier: 10885862302021
• UDI-Public: 10885862302021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 350-23-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male