MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE, ACTIVIT-E VIT E LINER-L-SZ 2-12MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-23-62
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 350-01-02 - talar implant sz 2 lt: (b)(6) 350-10-03 - ankle sz 3 locking clip: (b)(6) 350-11-03 - tibial plate fb sz 3 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) 351-90-21 - 3.5" pin pouch: (b)(6) 351-90-24 - talar trial screw pouch: (b)(6).
Event or Problem Description
Approximately 5 month(s) and 4 day(s) post-operative of a left taa, it was reported via clinical study that the patient experienced infection.It was stated that infection unlikely related to implant, replacement revision and debridement.The patient underwent a fixed ankle revision with the removal of the tibial insert.The outcome of this event is considered resolved and the clinical report indicates that this event is unlikely related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.H6: corrected component, and investigation clinical codes.

• Brand Name: VANTAGE, ACTIVIT-E VIT E LINER-L-SZ 2-12MM
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20401214
• Report Number: 1038671-2024-03862
• Device Sequence Number: 14297486
• Product Code: HSN
• UDI-Device Identifier: 10885862603890
• UDI-Public: 10885862603890
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 350-23-62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 04/07/2025
• Date Device Manufactured: 02/15/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Race: White