BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NK II CONSTRAINED FEMORAL COMPONENT

    MDR report key: 2012286 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00167
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS POSSIBLE THAT THE SCREW WAS LOST UPON OPENING THE PACKAGING, BUT WITHOUT FURTHER INFORMATION, THE EXACT CAUSE CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE RECORDS SHOW THE CORRECT AMOUNT OF SUBCOMPONENT SET SCREWS BEING USED. ADDITIONALLY, THE PACKAGING CHECK SHEET FOR THE INNER PACK AND CAVITY SEALER ROOMS SHOWS THAT THE PRESENCE OF SUBCOMPONENTS WAS VERIFIED BY THE PROCESSOR OF THE LOT AND THEN VERIFIED BY AN ADDITIONAL APPROVER. 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE BOX WAS OPENED, IT WAS DISCOVERED THAT THE SCREW WAS MISSING. THE SURGEON PROCEEDED TO IMPLANT THE DEVICE WITHOUT THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NK II CONSTRAINED FEMORAL COMPONENT KNEE PROSTHESIS JDI ZIMMER, INC. 60747069

    Patients

    Seq Age Sex Outcome Treatment
    1