BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2901027 · Received December 13, 2012

    Report

    Report Number
    1822565-2012-02535
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AS RETURNED, THE MEASURED DIMENSIONS OF THE ARTICULAR SURFACE WERE FOUND TO BE WITHIN SPECIFICATION; DAMAGE WAS OBSERVED ON BOTH SIDES. THE CAUSE OF THIS DAMAGE AND ITS POTENTIAL FOR INTERFERENCE WITH INSERTION ARE UNCERTAIN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LCCK POLY WOULD NOT SNAP INTO THE TIBIAL BASE PLATE CORRECTLY. SURGEON USED A BACKUP SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 62136811

    Patients

    Seq Age Sex Outcome Treatment
    1