BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3002374 · Received March 7, 2013

    Report

    Report Number
    1822565-2013-00450
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION APPEARS TO BE THE MOST LIKELY CAUSE OF FAILURE. AS RETURNED, THE DOVETAIL IS DEFORMED. MEASURED DIMENSIONS ARE WITHIN PRINT SPECIFICATIONS. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS UNABLE TO PROPERLY SEAT THE ARTICULAR SURFACE. ANOTHER SURFACE OF THE SAME SIZE AND LOT WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97067 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 62278653

    Patients

    Seq Age Sex Outcome Treatment
    1