BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT V

    MDR report key: 6137641 · Received December 1, 2016

    Report

    Report Number
    3006946279-2016-00447
    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. (B)(6). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, A SIMILAR DEVICE MANUFACTURED BY ZIMMER BIOMET IS CLEARED IN THE UNITED STATES UNDER 510K NUMBER K150850.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT EXPERIENCED LEAKAGE OF CEMENT INTO THE VETEBRAL CANAL, REQUIRING SURGICAL DECOMPRESSION FOR RELIEF OF THE RADICULAR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788397 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