BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT V

    MDR report key: 6138076 · Received December 1, 2016

    Report

    Report Number
    3006946279-2016-00448
    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. THE FOLLOWING SECTIONS 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 ARTICALE THAT A PATIENT EXPERIENCED CEMENT LEAKAGE WITHIN THE S1 FORAMEN, REQUIRING SURGICAL DECOMPRESSION FOR SYMPTOMATIC RELIEF OF RADICULAR PAIN. NO FURTHER INFORMATION IS AVAILABLE AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789688 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