BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN RHK ARTICULAR SURFACE W/HINGE POST

    MDR report key: 3980996 · Received July 24, 2014

    Report

    Report Number
    1822565-2014-00904
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 IS REPORTED THAT THE THREAD DID NOT FUNCTION PROPERLY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435006 NEXGEN RHK ARTICULAR SURFACE W/HINGE POST KRO ZIMMER, INC. 61524619

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR