BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA CEMENTED TIBIAL BROACH INSERTER

    MDR report key: 3915741 · Received June 12, 2014

    Report

    Report Number
    1822565-2014-00744
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 DISC FRACTURED FROM IMPACTOR DURING SURGERY. X-RAYS WERE TAKEN AND IT WAS DETERMINED THAT NO PIECE REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346753 PERSONA CEMENTED TIBIAL BROACH INSERTER JWH ZIMMER, INC. 62085420

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR