BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG CR ARTICULAR SURFACE

    MDR report key: 3040285 · Received April 3, 2013

    Report

    Report Number
    1822565-2013-00595
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 SURFACE WOULD NOT SEAT ONTO THE TM TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136932 NEXGEN PROLONG CR ARTICULAR SURFACE JWH ZIMMER, INC. 62230236

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR