BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R 40X2

    MDR report key: 6091091 · Received November 9, 2016

    Report

    Report Number
    3006946279-2016-00422
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 10, 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
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. UDI - (B)(4). CORRECTIVE ACTION HAS BEEN INITIATED BY ZIMMER BIOMET (B)(4) AND PACKAGE SUPPLIER TO ADDRESS REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER STERILE PACKAGING OF THE BONE CEMENT WAS NOT FULLY SEALED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739934 REFOBACIN BONE CEMENT R 40X2 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A513BB0237

    Patients

    Seq Age Sex Outcome Treatment
    1