BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN PLUS BONE CEMENT 40

    MDR report key: 7046630 · Received November 20, 2017

    Report

    Report Number
    3006946279-2017-00253
    Event Type
    Death
    Date Received
    November 20, 2017
    Date of Event
    July 26, 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). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3006946279 - 2017 - 00253. 3006946279 - 2017 - 00254. 3006946279 - 2017 - 00255. 3006946279 - 2017 - 00256. (B)(4). CONCOMITANT PRODUCTS: 3020830401, REFOBACIN PLUS BONE CEMENT 40 , QTY 4, LOTS: A642BJ2508, A651CJ1703, A644BJ2507, A705AK0104 REPORT SOURCE- FOREIGN. THE EVENT OCCURRED IN (B)(6). 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 FRANCE. 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 IN BLOOD PRESSURE AS THE PROSTHESIS WAS CEMENTED. THE SURGERY WAS ENDED BY CLOSING THE ARTHROTOMY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE A CARDIAC ULTRASOUND SHOWED EVIDENCE OF A CEMENT EMBOLISM. DESPITE THE REANIMATION MEASURES TAKEN, THE PATIENT EXPIRED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825065 REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A642BJ2508

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death