BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 40 REFOBACIN BONE CEMENT R

    MDR report key: 5532893 · Received March 29, 2016

    Report

    Report Number
    3006946279-2016-00028
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    February 29, 2016
    Report Date
    October 6, 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
    AU
    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. 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. 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 AND CORRECTED INFORMATION. (B)(4). REVIEW OF MANUFACTURING HISTORY REVEALED NO EVIDENCE OF PRODUCT NONCONFORMANCE. EVALUATION OF THE RETURNED DEVICE WAS UNREMARKABLE AND THE COMPLAINT CANNOT BE CONFIRMED. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED AS NO FAILURE WAS DETECTED; HOWEVER, CORRECTIVE ACTION HAS BEEN INITIATED FOR THE REPORTED ISSUE.

    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 AND COULD NOT ENTER THE CARTRIDGE. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE. ANOTHER PACKAGE OF CEMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188600 OPTIPAC-S 40 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A540A04870

    Patients

    Seq Age Sex Outcome Treatment
    1