BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM

    MDR report key: 17189916 · Received June 23, 2023

    Report

    Report Number
    1038671-2023-01445
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    June 5, 2023
    Report Date
    December 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307699
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    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

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 6710052 02-020-14-0335 - TRULIANT CR POR FEM CR POR RIGHT SZ 3.5. 6779222 02-022-55-3535 - TRULIANT POR TIB TRAY SIZE 3.5F/3.5T. 6684537 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 6737487 201-78-98 - 2 PK, SCHANZ PIN, 4MM X 130MM. S084683 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. S114926 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK. S125607 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED. A THICKER 13 CRC WAS IMPLANTED AND THE PATELLA WAS RESURFACED WITH A 38MM. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822795 TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862307699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H