BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3101762 · Received April 26, 2013

    Report

    Report Number
    1822565-2013-00715
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SUBOPTIMAL ORIENTATION PRIOR TO ATTEMPTED INSERTION APPEARS TO BE THE MOST LIKELY CAUSE OF FAILURE. EVAL: THE MEASURED DIMENSIONS OF THE DEVICE WERE FOUND TO BE WITHIN SPEC AS RETURNED; THE DOVETAIL FEATURE WAS DEFORMED. THIS TYPICALLY HAPPENS WHEN THE ARTICULAR SURFACE IS NOT OPTIMALLY PLACED AND ORIENTED BEFORE ATTEMPTED INSERTION USING THE ARTICULAR SURFACE INSERTER INSTRUMENT. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPEC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT LOCK INTO THE TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182146 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61697718

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR