BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 40 REFOBACIN BONE CEMENT R

    MDR report key: 5521079 · Received March 23, 2016

    Report

    Report Number
    3006946279-2016-00023
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 23, 2016
    Report Date
    October 3, 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
    HEALTH PROFESSIONAL

    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 FRANCE 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

    (B)(4). EVALUATION OF MANUFACTURING HISTORY REVEALED NO EVIDENCE OF PRODUCT NONCONFORMANCE. VISUAL INSPECTION OF CEMENT UNIT WAS UNREMARKABLE AND NO FAILURE WAS DETECTED; MOST LIKELY ROOT CAUSE OF THE EVENT IS ERRONEOUS STORAGE AND/OR MIXING PRACTICES. 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 WOULD NOT ENTER THE CARTRIDGE. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174892 OPTIPAC-S 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