BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 2, 11MM

    MDR report key: 24232950 · Received February 2, 2026

    Report

    Report Number
    1038671-2026-00099
    Event Type
    Injury
    Date Received
    February 2, 2026
    Report Date
    February 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-14-0320 - TRUL CR POR FEM CR POR RIGHT SZ 2: (B)(6). 02-022-55-2010 - TRUL POR TIB TRAY SIZE 2F/1T: (B)(6). 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK: (B)(6) 201-78-98 - 2 PK, SCHANZ PIN, 4MM X 130MM: (B)(6). 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK: (B)(6). 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK: (B)(6). 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK: (B)(6). A10012 - GPS IMPLANT KIT V2: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGEON PERFORMED A LINER EXCHANGE AND REMOVAL OF SCAR TISSUE DUE TO PATIENT REPORTS OF PAIN. NO ISSUES WITH SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293965 TRULIANT TIB IMP CRC INSERT SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862307521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11