BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIGHT MEDICAL TECHNOLOGY

    MDR report key: 111804 · Received August 6, 1997

    Report

    Report Number
    111804
    Event Type
    Injury
    Date Received
    August 6, 1997
    Date of Event
    June 19, 1997
    Report Date
    June 19, 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 TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT MEDICAL TECHNOLOGY Implant TIBIAL COMPONENT FRIENDLY-CEMENT KRP WRIGHT MEDICAL TECHNOLOGY TIBIAL C.F., INSERT M925390, CO-CR
    2 WRIGHT MEDICAL TECHNOLOGY Implant TIBIAL COMPONENT-CEMENT FRIENDLY KRP WRIGHT MEDICAL TECH INSERT CO-CR-TIBIAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R