BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE CEMENT

    MDR report key: 23726461 · Received December 4, 2025

    Report

    Report Number
    MW5179925
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 2, 2025
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, REDNESS AND SWELLING IN STUDY KNEE. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: YES, READMISSION: UNK (B)(6) 2025. 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
    2438695 BONE CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown