BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    MDR report key: 1040235 · Received May 7, 2008

    Report

    Report Number
    9613350-2008-00025
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: HEAD ADAPTER L/+4; 12/14-18/20, LOT: NI. METASUL LARGE DIAMETER HEAD 52/R, LOT NI. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUROM ACETABULAR, LARGE DIAMETER HEAD AND ZMR FEMORAL STEM WERE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 58/52 CODE R DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWA ZIMMER GMBH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R