BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT R 40X1

    MDR report key: 6247873 · Received January 12, 2017

    Report

    Report Number
    3006946279-2017-00015
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 15, 2016
    Report Date
    June 15, 2017
    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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE CLEARED UNDER 510K NUMBER K051411.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EVALUATION OF RETURNED DEVICE FOUND THE SUPPLIER SEALING WAS OPENED 1/6 OF THE LENGTH. THE MANUFACTURE SEALING WAS INTACT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO SUPPLIER PACKAGING ISSUE. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER STERILE PACKAGE WAS NOT FULLY SEALED. ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29549 BIOMET BONE CEMENT R 40X1 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A511AL1502

    Patients

    Seq Age Sex Outcome Treatment
    1