BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 1X40

    MDR report key: 6036330 · Received October 18, 2016

    Report

    Report Number
    3006946279-2016-00381
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). ZIMMER BIOMET FRANCE AND PACKAGING SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS TO ADDRESS REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN BOX OF BONE CEMENT WAS OPENED, THE INNER PACKAGE OF POWDER WAS LEAKING INTO THE OUTER PACKAGING. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY OR SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688206 REFOBACIN BONE CEMENT R 1X40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A552CK1626

    Patients

    Seq Age Sex Outcome Treatment
    1