BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT 1X40G

    MDR report key: 5808872 · Received July 20, 2016

    Report

    Report Number
    3006946279-2016-00241
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 1, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR PRODUCT CLEARED UNDER 510K NUMBER K150850. ZIMMER BIOMET (B)(4) AND THE PACKAGE SUPPLIER ARE IN THE PROCESS OF INITIATING MODIFICATIONS. RETURN EXPECTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGE WAS NOT FULLY SEALED. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462927 BIOMET BONE CEMENT 1X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A447BK1003

    Patients

    Seq Age Sex Outcome Treatment
    1