BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2 11MM

    MDR report key: 20137569 · Received September 4, 2024

    Report

    Report Number
    1038671-2024-03279
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 1, 2021
    Report Date
    September 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001733
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2. 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T. 200-02-35 - THREE PEG PATELLA 35MM. 999 - FEMORAL STEM.

    Description of Event or Problem · 0

    THE FOLLOWING ACTIONS WERE TAKEN: APPROXIMATELY 5 YEARS AND 9 MONTHS POST-OP THE PATIENT UNDERWENT ARTHROSCOPY AND DEBRIDEMENT WITH A BIOPSY. APPROXIMATELY 8 MONTHS LATER, THE PATIENT WAS REVIEWED IN CLINIC AND HAS BEEN LISTED FOR REVISION OF THE RIGHT KNEE +/- POLY EXCHANGE ALONE. FINALLY, THE PATIENT UNDERWENT REVISION SURGERY IN LATE SUMMER OF 2023. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL STUDY REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700621 LOGIC TIBIA PS MOD INSRT SZ 2 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001733

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| R