BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PATELLA COMPONENTS

    MDR report key: 6558746 · Received May 10, 2017

    Report

    Report Number
    0001822565-2017-03198
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    August 24, 2015
    Report Date
    September 30, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND ITS LOCATION IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. CONCOMITANT MEDICAL PRODUCTS - VANGUARD TIBIAL BEARING 63/67 X 12 CATALOG EP-183522 LOT 911000; VANGUARD FEMUR RIGHT 60 MM CATALOG 183044 LOT 386610; REGENEREX TIBIAL TRAY 67 MM CATALOG 141272 LOT 299140; MODULAR SPLINED STEM 40 MM CATALOG 141369 LOT 454860. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1822565-2017-03198, 1825034-2017-04449, 1825034-2017-04446, 1825034-2017-04447, AND 1825034-2017-04448.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340155 REGENEREX PATELLA COMPONENTS PROSTHESIS, KNEE MBH ZIMMER, INC. N/A 344230

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R