BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    STIMULAN RAPIDCURE

    MDR report key: 22410163 · Received July 7, 2025

    Report

    Report Number
    9617083-2025-01113
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    January 14, 2025
    Report Date
    June 17, 2025
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    MQV
    PMA / PMN Number
    141830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SOUTH AFRICAN CASE: SEPTIC ACL - THE FEMORAL TUNNEL AND DISTAL FEMUR WAS DEBRIDED AND ALL SEPTIC BONE DEBRIDED. STIMULAN RC 10CC - VANCOMYCIN 1GR AND GENTAMICIN 240MG (6ML) - MEDIUM BEADS AND BALANCE LARGE BEADS. BEADS WERE PUSHED INTO THE DEBRIDED BONE AND THE BALANCE (SMALL AMOUNT) INTO THE SURROUNDING SOFT TISSUE. A RASH AND SWELLING FOLLOWING IMPLANTATION OF STIMULAN OCCURRED. THE KNEE WAS WASHED OUT AGAIN. THE SURGEON HAS INDICATED THAT THEY CANNOT CONFIRM WHETHER THE REACTION WAS CAUSED BY THE ANTIBIOTICS OR THE STIMULAN BUT FROM REVIEWING THE DATA EVIDENCE IT IS HIGHLY UNLIKELY THAT STIMULAN WAS A CONTRIBUTING FACTOR TO THE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039154 STIMULAN RAPIDCURE STIMULAN MQV BIOCOMPOSITES LTD 20CC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H