BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC 28MM NEUT HYL GP

    MDR report key: 621467 · Received July 18, 2005

    Report

    Report Number
    1818910-2005-01187
    Event Type
    Injury
    Date Received
    July 18, 2005
    Date of Event
    July 13, 2005
    Report Date
    July 13, 2005
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WILL NEED REVISION DUE TO EXCESSIVE ECCENTRIC POLY WEAR BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC 28MM NEUT HYL GP TOTAL HIP REPLACEMENT KWB DEPUY ORTHOPAEDICS, INC. NA R3AA11013

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention