BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 80 REFOBACIN BONE CEMENT R

    MDR report key: 6097323 · Received November 11, 2016

    Report

    Report Number
    3006946279-2016-00426
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 13, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT INSPECTION REVEALS THAT THE SYSTEM IS NOT AIRTIGHT. NO NON-CONFORMITY HAS BEEN DETECTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. 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 OR DEVIATION. (B)(4).

    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
    747725 OPTIPAC 80 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A612C01210

    Patients

    Seq Age Sex Outcome Treatment
    1