BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM

    MDR report key: 15136921 · Received July 31, 2022

    Report

    Report Number
    1038671-2022-00863
    Event Type
    Injury
    Date Received
    July 31, 2022
    Date of Event
    June 24, 2022
    Report Date
    October 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174611
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. D10: 02-010-03-0250 - LOGIC CR FEMORAL CEM, LEFT, SZ 5, 5112526, 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, 4422098, 200-02-41 - THREE PEG PATELLA 41MM, 4832891. CORRECTIONAL/REMOVAL NUMBER: Z-0021-2022.

    Description of Event or Problem · 0

    THE PATIENT WAS REVISED DUE TO PAIN AND SYNOVITIS. MILD PITTING NOTICED. NEW 9MM CRC POLY IMPLANTED. NO OTHER KNOWN INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2923707 LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-49-5009 10885862174611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R