BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE, ACTIVIT-E VIT E LINER-L-SZ 2-12MM

    MDR report key: 20401214 · Received October 8, 2024

    Report

    Report Number
    1038671-2024-03862
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    August 15, 2024
    Report Date
    April 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862603890
    PMA / PMN Number
    K232002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    (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).

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718401 VANTAGE, ACTIVIT-E VIT E LINER-L-SZ 2-12MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862603890

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention SEE H11