BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT HV BN CMT 40G-JAPAN

    MDR report key: 7778593 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04559
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PK051496
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. DISCARDED AT USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CURE PERIOD OF COBALT BONE CEMENT WAS EARLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618341 COBALT HV BN CMT 40G-JAPAN BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 970660

    Patients

    Seq Age Sex Outcome Treatment
    1