BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2822420 · Received November 2, 2012

    Report

    Report Number
    1822565-2012-02256
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT LOCK IN PROPERLY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61795780

    Patients

    Seq Age Sex Outcome Treatment
    1