BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 40

    MDR report key: 5991070 · Received September 30, 2016

    Report

    Report Number
    3006946279-2016-00325
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. QUANTITY 2. PMS 510(K): - THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN THE US MANUFACTURES A SIMILAR PRODUCT UNDER 510K NUMBER K150850. ZIMMER BIOMET (B)(4) AND PACKAGE SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS TO ADDRESS REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY PRODUCT EVALUATION AND ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED. ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT A DELAY OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642578 BIOMET BONE CEMENT R 40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A506AL1501

    Patients

    Seq Age Sex Outcome Treatment
    1