BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM

    MDR report key: 17362347 · Received July 20, 2023

    Report

    Report Number
    1038671-2023-01720
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 30, 2023
    Report Date
    October 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312679
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS TRULIANT CR POR FEM CR POR LEFT SZ 4.5 (CAT#: 02-020-14-0245 / SERIAL#: (B)(6). TRULIANT POR TIB TRAY SIZE 4.5F/4.5T (CAT#: 02-022-55-4545 / SERIAL#: (B)(6). 2 PK, SCHANZ PIN, 4MM X 130MM (CAT#: 201-78-98 / SERIAL#: (B)(6). THREADED PIN SIZE 2.3 COLLARED 2PK (CAT#: 521-78-23 / SERIAL#: (B)(6). THREADED PIN SIZE 3.0 COLLARLESS 2PK (CAT#: 521-78-32 / SERIAL#: (B)(6). THREADED PIN SIZE 3.0 COLLARLESS 2PK (CAT#: 521-78-32 / SERIAL#: (B)(6). THREADED PIN SIZE 5.1 COLLARLESS 2PK (CAT#: 521-78-36 / SERIAL#: (B)(6). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL LEFT TKA, THE 59 Y/O PATIENT HAD REVISION DUE TO PAIN. THERE WAS NOT MUCH WEAR REPORTED UPON VISUAL EXAMINATION. THERE WAS NO ISSUES WITH POLY EXCHANGE. THE EXPLANTS ARE NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734479 TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM UNK 10885862312679

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Required Intervention