BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NK II DURASUL ULTRACONGRUENT TIBIAL INSERT

    MDR report key: 3243081 · Received July 18, 2013

    Report

    Report Number
    1822565-2013-01127
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS POSSIBLE THAT THE PROBLEMS ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE; HOWEVER, MORE INFORMATION WOULD BE NEEDED TO CONCLUSIVELY MAKE THAT DETERMINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE DEVICE WAS RECEIVED AND VISUALLY AND DIMENSIONALLY INSPECTED. AN EVAL OF THE DEVICE CONCLUDED THAT ONE OR BOTH SIDES OF THE POSTERIOR LOCKING TABS ARE SLIGHTLY DEFORMED, INDICATING THAT IT DID NOT PROPERLY SLIDE UNDER THE POSTERIOR LIP ON THE TIBIA PLATE. THIS MAY INDICATE THAT THE ARTICULAR SURFACE WAS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON HAD DIFFICULTY IN INSERTING THE ARTICULAR SURFACE. ANOTHER ARTICULAR SURFACE WAS OPENED AND INSERTED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336441 NK II DURASUL ULTRACONGRUENT TIBIAL INSERT JWH ZIMMER, INC. 62095645

    Patients

    Seq Age Sex Outcome Treatment
    1