BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 40 REFOBACIN BONE CEMENT R

    MDR report key: 5532892 · Received March 29, 2016

    Report

    Report Number
    3006946279-2016-00027
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Report Date
    March 1, 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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF MANUFACTURING HISTORY REVEALED NO EVIDENCE OF PRODUCT NONCONFORMANCE. EVALUATION OF RETURNED DEVICES WAS UNREMARKABLE AND NO FAILURE WAS DETECTED. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION; HOWEVER, CORRECTIVE ACTION HAS BEEN INITIATED FOR THE REPORTED ISSUE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE WHILE PREPARING THE CEMENT MIXTURE, THE MONOMER LIQUID WOULD NOT DISPENSE FROM THE POUCH AND WOULD NOT ENTER THE CYLINDER. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189252 OPTIPAC 40 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A526B17770

    Patients

    Seq Age Sex Outcome Treatment
    1