BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 40 REFOBACIN BONE CEMENT R

    MDR report key: 6096977 · Received November 11, 2016

    Report

    Report Number
    3006946279-2016-00425
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 12, 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
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT INSPECTION REVEALS THAT THE VACUUM WAS STOPPED EARLIER SO THAT THE MONOMER COULDN'T BE SUCKED INTO THE CARTRIDGE. THE PRODUCT INSPECTION REVEALS THAT THE POUCH HAD LEAKED BEFORE THE VACUUM WAS DONE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO USE ERROR. 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

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. UDI: (B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION OF THE BONE CEMENT, THE MONOMER LIQUID WOULD NOT DISPENSE INTO THE CYLINDER. THIS OCCURRED THREE TIMES WITH THE SAME LOT; HOWEVER, ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746060 OPTIPAC 40 REFOBACIN BONE CEMENT R PROSTHESIS, HIP MBB BIOMET FRANCE S.A.R.L. N/A A609B00330

    Patients

    Seq Age Sex Outcome Treatment
    1