BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 18812911 · Received February 29, 2024

    Report

    Report Number
    1038671-2024-00358
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    September 1, 2023
    Report Date
    March 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS - FEMUR PS CEM.Nº3 IZQ. (CAT# 02-010-01-0230 / SERIAL# (B)(6)) - BANDEJA TIBIAL LOGIC FIT 3F/3T (CAT# 02-012-45-3030 / SERIAL# (B)(6)) - VASTAGO EXT. 14X40MM (CAT# 204-34-04 / SERIAL# (B)(6)) - TORNILLO FIJACION VÁSTAGO A TIBIA (CAT# 204-70-00 / SERIAL# (B)(6)) ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED. THE PATIENT WAS REVISED FOR PAIN AND INSTABILITY; THERE IS NO INFORMATION PROVIDED ABOUT A MALFUNCTION OR WEAR ISSUE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT TKA, THE 76 Y/O FEMALE PATIENT HAD A REVISION DUE TO PAIN AND INSTABILITY WITH NO BONE LOSS. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE PATIENT STARTED EXPERIENCING PAIN AND INFLAMMATION SINCE 2021. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DOCTORS DID NOT WANT TO PROVIDE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310120 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 9MM UNK 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention