BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 60 REFOBACIN PLUS BONE CEMENT

    MDR report key: 5477993 · Received March 3, 2016

    Report

    Report Number
    3006946279-2016-00005
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 5, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496. DEVICE AVAILABILITY - THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SEND TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2016. DURING THE PROCEDURE WHILE PREPARING THE CEMENT MIXTURE, THE MONOMER LIQUID WOULD NOT DISPENSE FROM THE POUCH. ALSO DURING THE PROCEDURE WHILE PREPARING THE SECOND CEMENT MIXTURE, THE OPTIPAC PRESSURE HOSE FRACTURED. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133635 OPTIPAC-S 60 REFOBACIN PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC LOD BIOMET FRANCE S.A.R.L. N/A B345A05915

    Patients

    Seq Age Sex Outcome Treatment
    1