BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCK TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 15843228 · Received November 22, 2022

    Report

    Report Number
    0001822565-2022-03284
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 22, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF FRACTURED ON THE MEDIAL SIDE OF THE POST AND USAGE MARKS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FRACTURED. NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733650 CCK TIBIAL ARTICULAR SURFACE PROVISIONAL INSTRUMENT KNEE MBH ZIMMER BIOMET, INC. N/A 64373441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown