BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 50/44J

    MDR report key: 1131889 · Received August 18, 2008

    Report

    Report Number
    9613350-2008-00102
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, WHICH MARKETS THE DEVICES IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DUROM CUP WAS NOT SEATING INITIALLY, AND IT MIGRATED AND EVENTUALLY CAME TO SEAT IN A DIFFERENT ORIENTATION AND DID NOT ACHIEVE BONY INGROWTH. IT CAME OUT QUITE EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 50/44J DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWA ZIMMER GMBH 2330977

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R