BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 1X40

    MDR report key: 6067940 · Received October 31, 2016

    Report

    Report Number
    3006946279-2016-00407
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Report Date
    April 27, 2017
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EVALUATION OF RETURNED DEVICE FOUND OPENED SUPPLIER INNER SEALING. THE MANUFACTURER INNER SEALING WAS NOT DAMAGED. THE OUTER PACKAGING WAS NOT DAMAGED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO SUPPLIER PACKAGING ISSUE. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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. QUANTITY - 2. 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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3006946279-2016-00407 / 00408).

    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
    717760 REFOBACIN BONE CEMENT R 1X40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A541AI0108

    Patients

    Seq Age Sex Outcome Treatment
    1