BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS BONE CEMENT

    MDR report key: 23479418 · Received November 5, 2025

    Report

    Report Number
    MW5178557
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    March 12, 2024
    Report Date
    October 14, 2014
    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

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR COXARTHROSIS LEFT. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. TREATMENT/IMPACT: HOSPITALIZATION, MEDICAL INTERVENTION/ MODIFICATION, PHYSICAL THERAPY AND A "TOTAL HIP ARTHROPLASTY". 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
    2280901 PALACOS BONE CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC. 837439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown