BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN PLUS BONE CEMENT 40

    MDR report key: 5262904 · Received December 3, 2015

    Report

    Report Number
    3002806535-2015-04114
    Event Type
    Death
    Date Received
    December 3, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 25, 2015
    Manufacturer
    BIOMET FRANCE S.A.R.L
    Product Code
    LOD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE PATIENT EXPIRED DUE TO LIPEMIC EMBOLISM AFTER THE CEMENTATION OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794251 REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT LOD BIOMET FRANCE S.A.R.L N/A A503AK1833

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death