BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT SHELL/POLAR SCREWPLUG 50/HH

    MDR report key: 1131884 · Received August 18, 2008

    Report

    Report Number
    9613350-2008-00097
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 DURING HIP MOVEMENTS, THE INSERT DURASUL DIDN'T STAY ON THE ALLOFIT. THE SURGEON HAD TO CHANGE THE ALLOFIT AND HIS TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOFIT SHELL/POLAR SCREWPLUG 50/HH ALLOFIT ACETABULAR SYSTEM KWB ZIMMER GMBH 2426087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R