BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBIAL ARTICULAR SURFACE INSERTER

    MDR report key: 4110213 · Received September 11, 2014

    Report

    Report Number
    1822565-2014-01113
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 15, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE HOOK ON THE POLY INSERTER BROKE OFF AND COULD NOT BE LOCATED. IT WAS CONFIRMED VIA X-RAY THAT THE FRAGMENT WAS NOT RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563060 PERSONA TIBIAL ARTICULAR SURFACE INSERTER JWH ZIMMER, INC. 56573154

    Patients

    Seq Age Sex Outcome Treatment
    1