BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI TIB TRAY SZ B RM PMA

    MDR report key: 7823948 · Received August 28, 2018

    Report

    Report Number
    3002806535-2018-01023
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    June 26, 2018
    Report Date
    November 9, 2018
    Manufacturer
    .
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY RADIOGRAPH. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    REVISION DUE TO FAILED KNEE ARTHROPLASTY SECONDARY TO TIBIAL PERIPROSTHETIC FRACTURE AND ASEPTIC LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REVISION DUE TO FAILED KNEE ARTHROPLASTY SECONDARY TO TIBIAL PERIPROSTHETIC FRACTURE AND ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664661 OXF UNI TIB TRAY SZ B RM PMA JWH . 161230

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R