BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ZIMMER/HUDSON REAMER ATTACHMENT

    MDR report key: 3832915 · Received March 17, 2014

    Report

    Report Number
    8031000-2014-00157
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THA THE UNIVERSAL ZIMMER/HUDSON REAMER ATTACHMENT GRINDED UNTIL IT FAILED TO OPERATE. IT WAS NOTED THAT THERE WAS SMOKE, AND THERE WAS NO PATIENT IMPACT. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156988 UNIVERSAL ZIMMER/HUDSON REAMER ATTACHMENT UNIVERSAL ZIMMER/HUDSON REAMER ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1