BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 80 REFOBACIN PLUS BONE CEMENT

    MDR report key: 5548646 · Received April 5, 2016

    Report

    Report Number
    3006946279-2016-00035
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 8, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: EXPIRATION DATE - UNKNOWN. INITIAL REPORTER - NAME UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(64 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A KNEE ARTHROPLASTY ON (B)(6) 2016. DURING THE PROCEDURE WHILE PREPARING THE CEMENT MIXTURE, THE MONOMER LIQUID WOULD NOT DISPENSE FROM THE POUCH AND WOULD NOT MIX WITH THE POWDER. THERE WAS NO PATIENT INJURY AND A FIVE MINUTE DELAY OCCURRED IN THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203019 OPTIPAC-S 80 REFOBACIN PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A415A18718

    Patients

    Seq Age Sex Outcome Treatment
    1