BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT HV BN CMT 40G-JAPAN

    MDR report key: 8541736 · Received April 23, 2019

    Report

    Report Number
    0001825034-2019-01584
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K051496
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PICTURES OR DEVICE RECEIVED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACKAGE CONTAINING IMPLANT CEMENT WAS LEAKING. THIS OCCURRED IN THE OPERATING ROOM. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER NO INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335514 COBALT HV BN CMT 40G-JAPAN HIP PROSTHESIS LOD ZIMMER BIOMET, INC. N/A 346500

    Patients

    Seq Age Sex Outcome Treatment
    1