BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN BONE CEMENT R 1X40G

    MDR report key: 7046030 · Received November 20, 2017

    Report

    Report Number
    3006946279-2017-00252
    Event Type
    Death
    Date Received
    November 20, 2017
    Date of Event
    May 12, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE- FOREIGN. THE EVENT OCCURRED IN (B)(4). THE PRODUCT WITHIN THIS REPORT IS A COMBINATION PRODUCT. RESERVE SAMPLE WAS EVALUATED UNDER STANDARDIZED CONDITIONS AND NO FAILURE OF THE BONE CEMENT WAS FOUND; THE PRODUCT FUNCTIONED AS INTENDED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO A KNOWN RISK, KNOWN AS IMPLANTATION SYNDROME. THIS RISK IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU) OF THIS DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION HAS BEEN PERFORMED, CONSISTING OF A PRODUCT ANALYSIS AND A DOCUMENTARY REVIEW. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET (B)(4). PRODUCT ANALYSIS ON RETAINED SAMPLES FROM THE SAME BATCH SHOWED NO UNUSUAL BEHAVIOUR DURING MIXING, HANDLING OR SETTING. THE MOST PROBABLE REASON FOR DEATH IS THE CEMENT IMPLANTATION SYNDROME. THIS RISK IS DESCRIBED IN THE IFU PROVIDED WITH THE PRODUCT. NO NON-CONFORMITY HAS BEEN DETECTED CONCERNING THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT EXPERIENCED HEMODYNAMIC SHOCK AND HYPOTENSION WHEN THE CEMENT WAS INJECTED INTO THE FEMUR. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. DURING POST-OPERATIVE MONITORING, PATIENT WENT IN TO CARDIAC ARREST, COULD NOT BE RESUSCITATED, AND EXPIRED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824491 REFOBACIN BONE CEMENT R 1X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A647BJ2508

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death