BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT HV BN CMT 40G-JAPAN

    MDR report key: 8016790 · Received October 29, 2018

    Report

    Report Number
    0001825034-2018-09960
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Report Date
    April 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON EVALUATION OF THE RETURNED DEVICE, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 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). CONCOMITANT PRODUCTS: COBALT HV BN CMT 40G-JAPAN, PN 402282J, LN 233730. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-09961. 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 DIRT WAS FOUND ATTACHED TO THE STERILIZATION PACKAGING IT IS UNKNOWN IF THE DIRT WAS ON THE OUTSIDE OR THE INSIDE OF THE PACKAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856306 COBALT HV BN CMT 40G-JAPAN BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 359570

    Patients

    Seq Age Sex Outcome Treatment
    1