BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX BONE CEMENT FULL DOSE

    MDR report key: 23220905 · Received October 6, 2025

    Report

    Report Number
    MW5176908
    Event Type
    Death
    Date Received
    October 6, 2025
    Date of Event
    November 8, 2024
    Report Date
    October 1, 2025
    Manufacturer
    HOWMEDICA OSTEONICS CORP/ STRYKER CORP.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR DEATH - NOT OTHERWISE SPECIFIED, UNKNOWN CAUSE. TREATMENT/IMPACT: THE SUBJECT BEEN WITHDRAWN FROM THE STUDY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469676 SIMPLEX BONE CEMENT FULL DOSE BONE CEMENT LOD HOWMEDICA OSTEONICS CORP/ STRYKER CORP. 61911001 RCU042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death