BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTIM TOTAL KNEE

    MDR report key: 111864 · Received August 8, 1997

    Report

    Report Number
    111864
    Event Type
    Injury
    Date Received
    August 8, 1997
    Date of Event
    June 24, 1997
    Report Date
    June 24, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY
    Product Code
    KRP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LOOSE FEMORAL TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTIM TOTAL KNEE Implant FEMORAL COMPONENT AND CEMENT FRIENDLY TIBIAL KRP WRIGHT MEDICAL TECHNOLOGY FEMUR,TIBIAL,INSERT A026702,A030600,A01014
    2 ADVANTIM TOTAL KNEE Implant FEMORAL COMPONENT AND CEMENT FRIENDLY TIBIAL JWH WRIGHT MEDICAL TECHA TIBIA A030600, CO-CR
    3 ADVANTIM TOTAL KNEE Implant FEMORAL COMPONENT AND CEMENT FRIENDLY TIBIAL JWH WRIGTH MEDICAL TECHNA INSERT A01014

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R