BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 40X2

    MDR report key: 6090748 · Received November 9, 2016

    Report

    Report Number
    3006946279-2016-00421
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 10, 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
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, ZIMMER BIOMET MANUFACTURES A SIMILAR PRODUCT UNDER 510K NUMBER K150850. CORRECTIVE ACTION HAS BEEN INITIATED BY ZIMMER BIOMET (B)(4) AND THE PACKAGE SUPPLIER TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BONE CEMENT PACKAGING WAS DISCOVERED WITH A BREACHED SEAL, AND SOME OF THE CEMENT POWDER WAS COMING OUT OF THE PACKAGE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741779 BIOMET BONE CEMENT R 40X2 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A511BB0236

    Patients

    Seq Age Sex Outcome Treatment
    1