BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG LPS - FLEX ARTICULAR SURFACE

    MDR report key: 3040284 · Received April 3, 2013

    Report

    Report Number
    2648920-2013-00090
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION APPEARS TO BE THE MOST LIKELY CAUSE OF FAILURE. AS RETURNED, THE MEASURED DIMENSIONS ARE WITHIN SPECIFICATION; THE DOVETAIL FEATURE IS DEFORMED. THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT THE SURFACE A COUPLE OF TIMES AND IT WOULD NOT SEAT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135916 NEXGEN PROLONG LPS - FLEX ARTICULAR SURFACE JWH ZIMMER 61870301

    Patients

    Seq Age Sex Outcome Treatment
    1