BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 2X40

    MDR report key: 6036462 · Received October 18, 2016

    Report

    Report Number
    3006946279-2016-00382
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 21, 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

    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. (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN THE U.S. HAS REPORTING RESPONSIBILITY FOR A SIMILAR PRODUCT UNDER 510K NUMBER K150850. ZIMMER BIOMET (B)(4) AND PACKAGING SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS TO ADDRESS REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN BOX OF BONE CEMENT WAS OPENED, THE INNER PACKAGE OF POWDER WAS LEAKING INTO THE OUTER PACKAGING. THERE WAS NO PATIENT INJURY AND NO DELAY IN A PROCEDURE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689960 BIOMET BONE CEMENT R 2X40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A538AJ1305

    Patients

    Seq Age Sex Outcome Treatment
    1