BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINECTIV MODULAR NECK

    MDR report key: 5388908 · Received January 25, 2016

    Report

    Report Number
    1822565-2016-00135
    Event Type
    Injury
    Date Received
    January 25, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 30, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00801803602, VERSYS HIP FEMORAL HEAD LOT #62171407 MANUFACTURED BY ZIMMER B.V., (B)(4) THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE M/L TAPER KINECTIV NECK AND VERSYS FEMORAL HEAD WERE RETURNED FOR REVIEW. BLACK DEBRIS WAS NOTED ON THE HEAD AND NECK TAPERS. THE DIMENSIONS WERE FOUND CONFORMING TO PRINT SPECIFICATIONS WHERE MEASURED. THE DEBRIS WAS SEMI-QUANTITATIVELY ANALYZED UNDER SEM USING EDS. IT WAS DETERMINED THAT THE DEBRIS REVEALS FOREIGN ELEMENTS OF CARBON, OXYGEN, TITANIUM, AND CALCIUM. REVIEW OF THE DEVICE HISTORY RECORD REPORT SHOW NO DEVIATIONS OR ANOMALIES WERE NOTED IN THE MANUFACTURING PROCESS FOR THIS LOT. THE REPORTED DEVICES ARE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE PART LOT COMBINATION BASED ON THE COMPLAINT CATEGORY. THE FEMORAL HEAD AND NECK WERE FOUND TO BE COMPATIBLE; HOWEVER THE COMPATIBILITY OF ALL THE COMPONENTS CANNOT BE CONFIRMED SINCE THE PART NUMBER FOR THE SHELL, STEM AND LINER ARE UNKNOWN. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. DEVICE HISTORY RECORDS REVIEW FOR LOTS 61781668, 62171407, AND THE DEVICES HAVE BEEN MANUFACTURED, INSPECTED, STERILIZED AND PACKAGED IN ACCORDANCE TO THE ZIMMER QUALITY PROCEDURES AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT IS REPORTED A PATIENT WAS REVISED DUE TO PAIN AND TRUNIONOSIS METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48101 KINECTIV MODULAR NECK MEH MEH ZIMMER INC 61781668

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention