BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM XL TAPER STEM

    MDR report key: 2193425 · Received July 13, 2011

    Report

    Report Number
    1822565-2011-01639
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE STEM WAS OPENED, IT WAS DISCOVERED THAT THE STEM HAD BROKEN THROUGH THE PACKAGING, RENDERING THE DEVICE UNSTERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM XL TAPER STEM LPH ZIMMER INC 60079898

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR