BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA VE ARTICULAR SURFACE

    MDR report key: 3243195 · Received July 19, 2013

    Report

    Report Number
    1822565-2013-01131
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SURGEON HAD DIFFICULTY INSERTING THE ARTICULAR SURFACE. A NEW ARTICULAR WAS OPENED AND INSERTED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337969 PERSONA VE ARTICULAR SURFACE JWH ZIMMER, INC. 52262812

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR