BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM HARD BEARING RIM IMPACTOR

    MDR report key: 2182270 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01633
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A HEALTH PROFESSIONAL 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 THE IMPACTOR BROKE AT THE JUNCTION OF THE INSERTER AND THE PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM HARD BEARING RIM IMPACTOR HWA ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1