BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLASSIC KNEE SYSTEM TIBIAL INSERT

    MDR report key: 22186868 · Received June 11, 2025

    Report

    Report Number
    MW5171313
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 6, 2025
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025: PT HAD A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2024. SHE HAS PAIN, INSTABILITY IN HER JOINT AND LAXITY. SHE STATES IT GOES BACKWARDS. ON (B)(6) 2025, PT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569635 KLASSIC KNEE SYSTEM TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH TOTAL JOINT ORTHOPEDICS, INC. 5301.03.100 Q231002-2

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention