BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN BONE CEMENT R 1X40G

    MDR report key: 7046628 · Received November 20, 2017

    Report

    Report Number
    3006946279-2017-00250
    Event Type
    Death
    Date Received
    November 20, 2017
    Date of Event
    December 29, 2016
    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). (B)(4). REPORT SOURCE- FOREIGN. THE EVENT OCCURRED IN (B)(4). THE PRODUCT WITHIN THIS REPORT IS A COMBINATION PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 DECREASE OF THE BLOOD PRESSURE FOLLOWED BY A CARDIAC ARREST AS THE PROSTHESIS WAS CEMENTED. THE PATIENT WAS RECOVERED AFTER CARDIOVASCULAR REANIMATION. UPON WAKING, THE PATIENT PRESENTED WITH SEVERAL CARDIAC ARRESTS THAT GAVE RISE TO SEVERAL REANIMATIONS DURING 2HOURS AND 5 MINUTES. AFTER CONSULTATION, DECISION TO STOP THE REANIMATION WAS MADE. THE PATIENT EXPIRED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825062 REFOBACIN BONE CEMENT R 1X40G BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A622CA1904

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death REFOBACIN BONE CEMENT R 1X40G LOT 3003940001