BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE FLEX GENDER SOLUTIONS ULTRACONGRUENT ARTICULAR SURFACE PROVISIONAL

    MDR report key: 6017601 · Received October 11, 2016

    Report

    Report Number
    0001822565-2016-03646
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Report Date
    April 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PROVISIONALS IDENTIFIED THAT THEY WERE BOTH CHIPPED ON THE MEDIAL SIDE. THE DEVICES ALSO EXHIBITED GOUGES AND WEAR INDICATIVE OF REPEATED USE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS DUE TO WEAR AND TEAR FROM USE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL WAS BROKEN. IT IS UNKNOWN AT THIS TIME WHEN OR HOW THE DEVICE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667806 NATURAL-KNEE FLEX GENDER SOLUTIONS ULTRACONGRUENT ARTICULAR SURFACE PROVISIONAL KNEE PROVISIONAL HWT ZIMMER, INC. 62246438

    Patients

    Seq Age Sex Outcome Treatment
    1