BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN BONE CEMENT R 2X40G

    MDR report key: 8189813 · Received December 21, 2018

    Report

    Report Number
    3006946279-2018-00441
    Event Type
    Death
    Date Received
    December 21, 2018
    Date of Event
    August 13, 2014
    Report Date
    January 14, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    K150850
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). PATIENT DIED FOR UNKNOWN REASON. THERE IS NO INFORMATION THAT RELATES THE DEATH WITH THE USE OF OUR PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF COMPLAINT HISTORY SHOWED THAT THIS IS THE ONLY DEATH EVENT FOR THE INVOLVED BATCH OF PRODUCTS. NO INFORMATION IS AVAILABLE ABOUT THE CAUSE OF THE DEATH OF THE PATIENT. IT CANNOT BE DETERMINED IF THE DEATH OF THE PATIENT IS LINKED TO THE PRODUCT. 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 PATIENT DIED FOR UNKNOWN REASON 3 MONTHS AFTER THE CEMENTED RIGHT HIP PRIMARY TOTAL PROSTHETIC REPLACEMENT.

    Description of Event or Problem · 1

    PLEASE REFER TO REPORT 3006946279-2018-00441.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029549 REFOBACIN BONE CEMENT R 2X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A 228BAH2606

    Patients

    Seq Age Sex Outcome Treatment
    1 Death