BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN BONE CEMENT R 1X40-3

    MDR report key: 20117655 · Received September 2, 2024

    Report

    Report Number
    3006946279-2024-00054
    Event Type
    Death
    Date Received
    September 2, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    00887868358388
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. AS THE PRODUCT REMAINS IMPLANTED; VISUAL EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. HOWEVER, A RETAIN SAMPLE OF BATCH HAS BEEN TESTED IN THE LABORATORY UNDER STANDARDIZED CONDITIONS. NO UNUSUAL SETTING TEMPERATURE HAS BEEN NOTICED DURING THE TEST (TEMPERATURE OF THE CEMENT NOT EXCEEDING 90°C). A REVIEW OF THE DEVICE MANUFACTURING RECORDS, RAW MATERIAL CERTIFICATE AND STERILIZATION CERTIFICATE CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION WITHIN ONE YEAR PRIOR TO THE NOTIFICATION DATE AND THEREAFTER. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. THE REVIEW IDENTIFIED PATIENT COMORBIDITIES AS CONTRIBUTING FACTOR OF THE EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT CAN BE NOTICED THAT BONE CEMENT IMPLANTATION SYNDROME IS A KNOWN INHERENT RISK OF DEVICE IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) D-10: 3003940001-3, REFOBACIN BONE CEMENT R 1X40-3, AW13DA0504. G2 ¿ FOREIGN ¿ FRANCE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE WITH UNKNOWN PRODUCT. THE EIGHTY-TWO-YEAR-OLD PATIENT WAS REVISED A MONTH AGO DUE TO FREQUENT FALLS AND LEFT HIP FRACTURE. DURING THE CEMENTING OF THE NEW STEM PATIENT WENT INTO SUDDEN SHOCK, WAS TRANSFERRED TO ICU, INTUBATED, VENTILATED, AND SEDATED. AFTER A CARDIOLOGY CONSULTATION, A CEMENT EMBOLISM WAS DIAGNOSED. THE PATIENT LATER PASSED AWAY DUE TO OBSTRUCTIVE CARDIOGENIC SHOCK ON PROBABLE CEMENT EMBOLI INTRAOPERATIVELY FROM A STEM CHANGE, COMPLICATED BY MULTIVISCERAL FAILURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882502 REFOBACIN BONE CEMENT R 1X40-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A AW13DA0504 00887868358388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death SEE H11 NARRATIVE