BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT

    MDR report key: 23657871 · Received November 26, 2025

    Report

    Report Number
    3004153240-2025-00022
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    July 9, 2025
    Report Date
    November 26, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    JWH
    UDI-DI
    M572TCR3011113011
    PMA / PMN Number
    K230846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORD INDICATES THE DEVICE WA MANUFACTURED TO SPECIFICATION. IT WAS REPORTED THAT THE PATIENT FELL, WHICH LIKELY CAUSED THE TIBIAL LOOSENING. IT CANNOT BE DEFINITIVELY DETERMINED IF THE COMPONENT CONTRIBUTED TO THE FAILURE MODE.

    Description of Event or Problem · 0

    PATIENT IS HAVING REVISION PROCEDURE TO ADDRESS TIBIAL COMPONENT LOOSENING FROM (B)(6) 2025 TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137086 ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT TOTAL KNEE REPLACEMENT JWH RESTOR3D, INC. TCR-301-1113 M572TCR3011113011

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention