BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT V

    MDR report key: 6138060 · Received December 1, 2016

    Report

    Report Number
    3006946279-2016-00449
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    October 19, 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS EXPERIENCED TRANSIENT NEUROLOGICAL DEFICIT DUE TO LOCAL EXTRAVASATION OF PMMA, WHICH RESOLVED UNDER ANTI-INFLAMMATORY MEDICATION. NO FURTHER INFORMATION IS AVAILABLE AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788446 BIOMET BONE CEMENT V BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention