BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT

    MDR report key: 17557394 · Received August 15, 2023

    Report

    Report Number
    MW5144597
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    March 13, 2015
    Report Date
    August 14, 2023
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    KIH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY, JOINT EFFUSION, PAIN (ALL LOAD RELATED) IN LEFT KNEE, RADIOLUCENT LINES IN X-RAY, SUSPECTED PROTHESIS LOOSENING. 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
    1279847 CEMENT DISPENSER, CEMENT KIH HERAEUS MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown