BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DE PUY MFG.

    MDR report key: 85369 · Received February 12, 1997

    Report

    Report Number
    85369
    Event Type
    Injury
    Date Received
    February 12, 1997
    Date of Event
    September 13, 1996
    Report Date
    September 26, 1996
    Manufacturer
    DE PUY MFG.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACETABULAR COMPONENT LOOSE; NOT SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DE PUY MFG. Implant ENDURON POLYETHYLENE ID, LIP, ACETABULAR CUP KWB DE PUY MFG. * 606000015

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R