BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE

    MDR report key: 7999892 · Received October 23, 2018

    Report

    Report Number
    MW5080788
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    April 24, 2018
    Report Date
    October 22, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD TO UNDERGO A REVISION OF THEIR TOTAL KNEE DUE TO EARLY LOOSENING OF A LEFT TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838713 TOTAL KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI - CONSTRAINED CEMENTED JWH AESCULAP IMPLANT SYSTEMS, LLC NX058Z

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention