BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC

    MDR report key: 6347500 · Received February 21, 2017

    Report

    Report Number
    0001825034-2017-00836
    Event Type
    Injury
    Date Received
    February 21, 2017
    Report Date
    May 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NJL
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    PRODUCT IDENTIFICATION IS UNKNOWN.

    Description of Event or Problem · 1

    A PATIENT WHO UNDERWENT A KNEE ARTHROPLASTY HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127565 UNKNOWN AGC PROTHESIS, KNEE NJL BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other