BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT V

    MDR report key: 6138126 · Received December 1, 2016

    Report

    Report Number
    3006946279-2016-00451
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    January 1, 2008
    Report Date
    November 30, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED IN THE ARTICLE: DATE OF EVENT - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, INITIAL REPORTER - (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, A PRODUCT MARKETED BY ZIMMER BIOMET IS CLEARED FOR DISTRIBUTION IN THE U.S. UNDER 510K NUMBER K150850. MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT EXPERIENCED LIMB MOTOR DEFICIT RELATED TO CEMENT LEAKAGE CLOSE TO THE S1 NERVE ROOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789692 BIOMET BONE CEMENT V BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other