BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3802435 · Received February 21, 2014

    Report

    Report Number
    1822565-2014-00212
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 ARTICULAR SURFACE WAS BENT WHEN IT WAS BEING INSERTED. THE SURGEON USED ANOTHER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110019 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 62544281

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR