BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 60 REFOBACIN® PLUS BONE CEMENT

    MDR report key: 6045471 · Received October 20, 2016

    Report

    Report Number
    3006946279-2016-00389
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 21, 2016
    Report Date
    April 13, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NOT CONFIRMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PRODUCT INSPECTION REVEALED THAT THE VACUUM WAS STOPPED EARLY, SUCH THAT THE MONOMER COULD NOT BE PULLED INTO THE CARTRIDGE. ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. 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.

    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.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE BONE CEMENT, THE MONOMER LIQUID WOULD NOT DISPENSE INTO THE CYLINDER. THERE WAS NO PATIENT INJURY AND ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694154 OPTIPAC 60 REFOBACIN® PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A602C11455

    Patients

    Seq Age Sex Outcome Treatment
    1