BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL PLATE FB SZ 1 LT

    MDR report key: 18620233 · Received January 31, 2024

    Report

    Report Number
    1038671-2024-00144
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    November 9, 2023
    Report Date
    January 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276131
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 350-21-21 - TIBIAL INSERT FB SZ 1 LT 8MM: 5299361, 350-10-01 - ANKLE SZ 1 LOCKING CLIP: 7041185, 350-01-01 - TALAR IMPLANT SZ 1 LT 6860302, 351-91-03 - RECIP SAWBLADE 8X50X1MM: 038799.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, THE 62 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TAA ON (B)(6) 2022 AND PRESENTED WITH LUCENCY AND CYST FORMATION APPROXIMATELY 1 YEAR POST INITIAL PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT'S RADIOGRAPHIC FINDINGS DETERMINED THERE IS INCREASED LUCENCY ABOUT THE TIBIAL COMPONENT COMPARED TO (B)(6) 2023. SUBJECT CAME IN FOR A FOLLOW-UP VISIT PERTAINING TO THE FINDINGS ON (B)(6) 2024. ON (B)(6) 2024, RADIOGRAPHIC FINDINGS STATED THAT THERE WAS STABLE LUCENCY ABOUT THE TIBIAL COMPONENT COMPARED TO (B)(6) 2023, BUT INCREASED SINCE (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THE ACTION TAKEN WAS MEDICATION AND THE OUTCOME OF THIS EVENT IS CONTINUING. 350-11-01 - TIBIAL PLATE FB SZ 1 LT: 6694220. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382818 TIBIAL PLATE FB SZ 1 LT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862276131

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female