BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CMENT R 1X40 JP

    MDR report key: 23243408 · Received October 8, 2025

    Report

    Report Number
    3006946279-2025-00116
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 20, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(6). G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172408. D10 - ASSOCIATED MEDICAL DEVICES: BIOMET BONE CMENT R 1X40 JP; ITEM# 110035372; LOT# V49AAD0217 G2 - FOREIGN: JAPAN. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT CAN BE NOTICED THAT PULMONARY EMBOLISM IS PART OF THE ADVERSE EVENT LISTED IN THE INSTRUCTION FOR USE DRAFT PROVIDED TO JAPAN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 15 MINUTES AFTER THE USE OF BONE CEMENT, SUSPICION OF A PULMONARY THROMBOEMBOLISM AROSE. FOLLOWING CONFIRMATION, THE ANAESTHESIOLOGIST INTERVENED AND THE SURGERY WAS IMMEDIATELY HALTED. THE PATIENT WAS TRANSFERRED TO THE ICU. ALTHOUGH THE PATIENT¿S HEART RATE HAS SINCE RECOVERED, THE PATIENT REMAINS UNCONSCIOUS AND IS CURRENTLY UNDER OBSERVATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565474 BIOMET BONE CMENT R 1X40 JP BONE CEMENT LOD BIOMET FRANCE S.A.R.L. V28AAC0811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| H SEE H11 NARRATIVE.