BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM HB RIM IMPACTOR

    MDR report key: 2013290 · Received March 8, 2011

    Report

    Report Number
    1822565-2011-00532
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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 THE RIM IMPACTOR FRACTURED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM HB RIM IMPACTOR HWA ZIMMER, INC. 61318449

    Patients

    Seq Age Sex Outcome Treatment
    1