BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T

    MDR report key: 19626945 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02177
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 18, 2024
    Report Date
    November 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305848
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 7053542 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5 (B)(6) 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T 6995858 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND INSERT. PHOTOS PROVIDED SHOW SIGNS OF TIBIAL INSERT POLY WEAR. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. CHAIN OF COMMAND DUE TO RECALL, HOSPITAL WILL NOT RELEASE INDICATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449003 TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862305848

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention SEE H11