BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIPAC 80 BIOMET BONE CEMENT R

    MDR report key: 11997295 · Received June 15, 2021

    Report

    Report Number
    3006946279-2021-00093
    Event Type
    Death
    Date Received
    June 15, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN, HEALTH PROFESSIONAL - EVENT OCCURRED IN (B)(6). 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. THE IFU OF THE PRODUCT HAS BEEN REVIEWED AND IT WAS FOUND THAT THE IFU FOR OPTIPAC 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". 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 IMMEDIATELY AFTER INJECTING OPTIPAC CEMENT INTO THE MEDULLARY CAVITY WITH THA SURGERY, THE PATIENT'S BLOOD PRESSURE DROPPED SHARPLY. EVENTUALLY, THE PATIENT WAS REPORTED DEAD. THE SURGEON COMMENTED THAT THE PATIENT WAS IN POOR CONDITION AND THERE WAS NO PROBLEM WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894319 OPTIPAC 80 BIOMET BONE CEMENT R ORTHOPAEDIC CEMENT, MEDICATED MBB BIOMET FRANCE S.A.R.L. AZ19AF2906

    Patients

    Seq Age Sex Outcome Treatment
    1 Death