BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIPAC 80 BIOMET BONE CEMENT R

    MDR report key: 14486074 · Received May 24, 2022

    Report

    Report Number
    3006946279-2022-00045
    Event Type
    Death
    Date Received
    May 24, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE REVIEW OF THE STERILIZATION CERTIFICATE INDICATES THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATION. THE REVIEW OF THE RAW MATERIAL CERTIFICATE SHOWS NO NON CONFORMITY OR DEVIATION. COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART/LOT COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT 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 PATIENT HAD A CARDIOPULMONARY ARREST AFTER CEMENT USE. SURGEON WAS USED CEMENT DURING OPERATION OF THE HEMI ARTHROPLASTY. AFTER STEM FIXATION, THE PATIENT BECAME HYPOTENSIVE, DYSPNEIC, AND WENT INTO CARDIOPULMONARY ARREST, RESULTING IN THE DEATH OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT PATIENT HAD A CARDIOPULMONARY ARREST AFTER CEMENT USE. SURGEON WAS USED CEMENT DURING OPERATION OF THE HEMI ARTHROPLASTY. AFTER STEM FIXATION, THE PATIENT BECAME HYPOTENSIVE, DYSPNEIC, AND WENT INTO CARDIOPULMONARY ARREST, RESULTING IN THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206920 OPTIPAC 80 BIOMET BONE CEMENT R BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AY20BA0414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death