BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 40X1

    MDR report key: 5995967 · Received October 4, 2016

    Report

    Report Number
    3006946279-2016-00354
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    August 30, 2016
    Report Date
    March 30, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. ZIMMER BIOMET FRANCE AND PACKAGING SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS TO ADDRESS REPORTED ISSUE. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00354 / 00355).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON EXAMINATION OF THE PRODUCT, IT WAS NOTED THAT A PORTION OF THE INNER PACKAGING WAS NOT SEALED. THE OUTER POUCH WAS NOT DAMAGED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO AN INADEQUATE SEAL FORMED WITH SEALING MATERIAL USED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    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 A TEN MINUTE DELAY IN A PROCEDURE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648449 REFOBACIN BONE CEMENT R 40X1 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A418AF2405

    Patients

    Seq Age Sex Outcome Treatment
    1