BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 1X40G

    MDR report key: 10216529 · Received July 1, 2020

    Report

    Report Number
    3006946279-2020-00120
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    K150850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, E1, B5, G4, H2, H6, H10. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE, IT COULD NOT BE ANALYZED. THE EVENT WAS CONFIRMED ON PICTURE. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. 4 COMPLAINTS HAVE BEEN RECORDED OVER THE BATCH A818AD2504. ACCORDING TO AVAILABLE DATA, THE MOST PROBABLE ROOT CAUSE IS DUE TO PACKAGING ISSUE (SEALING PROCESS). CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. A CUSTOMER LETTER WILL BE SEND REGARDING THE 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE INNER STERILE PACKAGING WAS FOUND OPENED DURING THE OPERATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THEREFORE IT WILL NOT BE ANALYZED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER STERILE PACKAGING WAS OPENED DURING THE OPERATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684590 REFOBACIN BONE CEMENT R 1X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A818AD2504

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR