BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE REPLACEMENT

    MDR report key: 7979716 · Received October 17, 2018

    Report

    Report Number
    MW5080677
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    July 28, 2018
    Report Date
    October 4, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS LLC / B. BRAUN
    Product Code
    HSX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOOSENING OF ENTIRE IMPLANT, MORE PROFOUND ON TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814191 TOTAL KNEE REPLACEMENT PROSTHESIS KNEE, FEMOROTIBIAL CONSTRAINED CEMENT METAL POLYMER HSX AESCULAP IMPLANT SYSTEMS LLC / B. BRAUN VEGA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention