BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMENT G

    MDR report key: 24481959 · Received March 2, 2026

    Report

    Report Number
    3005304945-2026-00002
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    December 3, 2025
    Report Date
    March 2, 2026
    Manufacturer
    BONEUSUPPORT AB
    Product Code
    QRR
    PMA / PMN Number
    K234008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE USED THE LIMITED INFORMATION FROM THE FDA REPORT PROVIDED ANONYMOUSLY BY THE PATIENT. IN SHORT, CERAMENT G (WITH GENTAMICIN) WAS IMPLANTED IN A LARGE BONE DEFECT OF THE LEFT FEMUR TO MANAGE OSTEOMYELITIS IN A 56 Y.O. FEMALE. SHORTLY LATER, CERAMENT G WAS SURGICALLY REMOVED AND REPLACED BY ANOTHER BONE GRAFT SUBSTITUTE. INTRAOPERATIVELY THE SURGEON NOTED THAT "CERAMENT G LOOKED UNFORMED AND NOT NORMAL". CERAMENT G IS INJECTED AS A PASTE INTO THE BONE VOID AND HARDENS IN SITU WITHIN 15 MINUTES. AFTER WOUND CLOSURE, THE PHYSIOLOGICAL AND EXPECTED DEGRADATION AND RESORPTION PROCESS OF THE PRODUCT STARTS, WHICH FINALLY LEADS TO NEW BONE FORMATION. AROUND ONE WEEK AFTER SURGERY, THE DEGRADATION AND RESORPTION PROCESS HAS CONTINUED AND CERAMENT G IS NOT IN A HARD CONSISTENCY ANYMORE. WE BELIEVE THAT THE SURGEON DESCRIBED THIS PHYSIOLOGICAL AND NORMAL PROCESS AS "CERAMENT G LOOKED UNFORMED AND NOT NORMAL".FINALLY, IT WAS CONCLUDED THAT THE PATIENT DEVELOPED A "DRESS REACTION FROM ORTHOPEDIC PRODUCTS". DURING THE COURSE OF TREATMENT, ADDITIONALLY PNEUMONIA WAS DIAGNOSED AND TREATED WITH FURTHER ANTIBIOTICS. INFORMATION REGARDING THE PATIENT'S PRIOR MEDICAL HISTORY, COMORBIDITIES, AND CONCOMITANT MEDICATIONS IS NOT AVAILABLE, WHICH LIMITS A COMPREHENSIVE ASSESSMENT OF POTENTIAL CONTRIBUTING FACTORS AND PHARMACOLOGICAL INTERACTIONS. CERAMENT G IS AN INJECTABLE CERAMIC BONE GRAFT SUBSTITUTE, CONSISTING OF CALCIUM SULFATE, HYDROXYAPATITE AND GENTAMICIN SULFATE. NONE OF THE COMPONENTS IN CERAMENT G WERE IDENTIFIED AS CAUSATIVE DRUGS IN ANY OF THE SCIENTIFIC REPORTS ON DRESS. BASED ON THE SCIENTIFIC KNOWLEDGE IT CAN BE CONCLUDED THAT THE DRESS REACTION IS NOT RELATED TO CERAMENT G. DUE TO THE UNLIKELIHOOD OF RECEIVING FURTHER INFORMATION, THE ABOVE CONCLUSION CAN BE SEEN AS FINAL. EVALUATION OF PRODUCT: REVIEW OF THE BATCH RECORDS INCLUDING QUALITY CONTROL RELEASE RESULTS HAS NOT BEEN PERFORMED, BECAUSE BATCH NUMBERS ARE NOT KNOWN. RECOMMENDED ACTIONS, IF ANY: EVENT IS NOT RELATED TO THE DEVICE, AND THEREFORE NO CORRECTIVE ACTIONS ARE REQUIRED. CONCLUSION: DRESS REACTION IS NOT RELATED TO CERAMENT G. COMPLAINT SUBCLASS ACCORDING TO INTERNAL PROCEDURE: ADVERSE EVENT NOT RELATED TO DEVICE.

    Description of Event or Problem · 0

    ON THE 13TH OF FEBRUARY 2026, FDA INFORMED US VIA EMAIL THAT A PATIENT HAS ANONYMOUSLY REPORTED A SERIOUS ADVERSE EVENT AFTER THE USE OF CERAMENT G. FOR DETAILS OF THE EVENT SEE FDA REPORT: MW5182486. THE PATIENT DECIDED TO REMAIN ANONYMOUS; THEREFORE, IT IS NOT POSSIBLE TO RECEIVE ANY FURTHER INFORMATION (E.G. PATIENT CHARACTERISTICS, CLASSIFICATION OF DISEASE, PATIENT'S MEDICAL HISTORY INCLUDING PRE-EXISTING MEDICAL CONDITIONS, TESTS/LABORATORY DATA, RADIOGRAPHS, AND MEDICATIONS THAT WERE ADMINISTERED DURING THE COURSE OF THE TREATMENT. HOSPITAL: (B)(6). PRODUCT USED: CERAMENT G. DATE OF EVENT: 3RD DECEMBER 2025. DATE OF THE REPORT TO FDA (FROM INITIAL REPORTER): 11TH JANUARY 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539793 CERAMENT G CERAMENT G QRR BONEUSUPPORT AB UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| L