BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM CANNULATED REAMER

    MDR report key: 3853489 · Received April 4, 2014

    Report

    Report Number
    1822565-2014-00456
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 IS REPORTED THAT THE REAMER FRACTURED WHILE REAMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203679 ZIMMER TM CANNULATED REAMER HSD ZIMMER, INC. 62495449

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR