BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT HV BN CMT 40G-JAPAN

    MDR report key: 5833490 · Received July 29, 2016

    Report

    Report Number
    0001825034-2016-02788
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Report Date
    June 29, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US, BUT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496. DEVICE DISCARDED AT HOSPITAL

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLYMER PACKAGE WAS NOT FULLY SEALED AND WAS LEAKING. THERE WAS NO PATIENT INJURY OR DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484961 COBALT HV BN CMT 40G-JAPAN BONE CEMENT LOD BIOMET ORTHOPEDICS N/A 145990

    Patients

    Seq Age Sex Outcome Treatment
    1