BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENTS

    MDR report key: 1030859 · Received April 9, 2008

    Report

    Report Number
    9613350-2008-00021
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    February 28, 2008
    Report Date
    April 9, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REVISED IN 2008 - EXCELLENT CUP POSITION AND APPEARED TO BE BOTTOMED OUT - IMPLANT WAS LOOSE, DID NOT HAVE BONY INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENTS DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENT KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R