BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN REVISION 40X1

    MDR report key: 6073076 · Received November 2, 2016

    Report

    Report Number
    3006946279-2016-00419
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 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
    PO
    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. UDI#: (B)(4). ZIMMER BIOMET (B)(4) AND PACKAGING SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS TO ADDRESS REPORTED ISSUE. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3006946279-2016-00418 / 00419).

    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. THERE WAS NO PATIENT INJURY AND NO DELAY IN A PROCEDURE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724637 REFOBACIN REVISION 40X1 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A450AI2931

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR