BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 2X40G

    MDR report key: 5780524 · Received July 9, 2016

    Report

    Report Number
    3006946279-2016-00225
    Event Type
    Malfunction
    Date Received
    July 9, 2016
    Report Date
    June 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
    IT
    Reporter Occupation
    OTHER

    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. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI. EXPIRATION DATE - NI. QTY: 2. REPORTER NAME - NI. THIS PRODUCT IS NOT LICENSED IN THE UNITED STATES, HOWEVER, ZIMMER BIOMET DISTRIBUTES A SIMILAR PRODUCT LICENSED UNDER 510K NUMBER K150850. MANUFACTURE DATE ¿ NI. DISCARDED.

    Description of Event or Problem · 1

    A PACKAGE OF BONE CEMENT WAS FOUND WITH A BREACHED SEAL. NO PATIENT INJURY OR DELAY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434346 BIOMET BONE CEMENT R 2X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A446AK1003

    Patients

    Seq Age Sex Outcome Treatment
    1