BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFOBACIN BONE CEMENT R 2X40-3

    MDR report key: 11983150 · Received June 11, 2021

    Report

    Report Number
    3006946279-2021-00091
    Event Type
    Death
    Date Received
    June 11, 2021
    Date of Event
    May 6, 2021
    Report Date
    October 13, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP IS TO RELAY ADDITIONAL INFORMATION. RESERVE SAMPLE FROM THE SAME LOT WAS RECEIVED FROM THE HOSPITAL AND TESTED UNDER STANDARDIZED CONDITIONS. THE PRODUCT DID NOT SHOW ANY UNUSUAL BEHAVIOR DURING MIXING, HANDLING OR SETTING. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CEMENT WAS PUT INTO FEMUR, THE SATURATION IN THE BLOOD PRESSURE DROPPED IN BOTH CASES. (SEPARATE INCIDENTS). FIRST PATIENT PASSED AWAY, 3 MINUTES INTO RECOVERY. SECOND PATIENT WAS REINTEGRATED AND SENT TO CRITICAL CARE. (B)(4) WAS CREATED TO INVESTIGATE ON THE SECOND PATIENT.

    Additional Manufacturer Narrative · 1

    THIS IS A COMBINATION PRODUCT. (B)(4). FOREIGN REPORT SOURCE: (B)(6). THE IFU OF THE PRODUCT HAS BEEN REVIEWED AND IT WAS FOUND THAT THE IFU FOR CEMENT PACK CONTAINS RISK -REDUCING WARNING AND DIFFERENT PRECAUTIONS REGARDING SEVERE COMPLICATIONS: "AFTER PREPARATION OF THE PROSTHESIS BED OR DIRECTLY AFTER THE IMPLANTATION OF THE CEMENT AND PROSTHESIS, PRESSURE RISE IN THE MEDULLARY CANAL MAY CAUSE A TEMPORARY FALL IN BLOOD PRESSURE. IN ADDITION TO HYPOTENSION, PULMONARY EMBOLISM AND CARDIAC ARREST, WITH THEIR POTENTIALLY FATAL CONSEQUENCES, HAVE BEEN ENCOUNTERED IN RARE CASES". THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE DATASHEET ON THE COMPOSITION OF THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE FOUND. NO OTHER COMPLAINT ON PATIENT DEATH FOLLOWING BONE CEMENT IMPLANTATION SYNDROME WAS RECORDED ON THE BATCH SINCE EVER, AND NO OTHER COMPLAINT ON PATIENT DEATH FOLLOWING BONE CEMENT IMPLANTATION SYNDROME WAS RECORDED ON THE REFERENCE SINCE EVER. RESERVE SAMPLE FROM THE SAME LOT WAS TESTED UNDER STANDARDIZED CONDITIONS. THE PRODUCT DID NOT SHOW ANY UNUSUAL BEHAVIOR DURING MIXING, HANDLING OR SETTING. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CEMENT WAS PUT INTO FEMUR, THE SATURATION IN THE BLOOD PRESSURE DROPPED IN BOTH CASES. FIRST PATIENT PASSED AWAY, 3 MINUTES INTO RECOVERY. SECOND PATIENT WAS REINTEGRATED AND SENT TO CRITICAL CARE. (B)(4) WAS CREATED TO INVESTIGATE ON THE SECOND PATIENT. THE CURRENT REPORT CORRESPONDS TO THE FIRST PATIENT (DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881193 REFOBACIN BONE CEMENT R 2X40-3 ORTHOPAEDIC CEMENT, MEDICATED MBB BIOMET FRANCE S.A.R.L. A951BE2703

    Patients

    Seq Age Sex Outcome Treatment
    1 Death