BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    MDR report key: 5519597 · Received March 23, 2016

    Report

    Report Number
    3006946279-2016-00019
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    December 10, 2015
    Report Date
    September 30, 2016
    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
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6). MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE WHILE PREPARING THE CEMENT MIXTURE, THE MONOMER LIQUID WOULD NOT DISPENSE FROM THE POUCH. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175535 OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A448A04835

    Patients

    Seq Age Sex Outcome Treatment
    1