BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 23850051 · Received December 19, 2025

    Report

    Report Number
    0002244564-2025-00010
    Event Type
    Injury
    Date Received
    December 19, 2025
    Report Date
    December 12, 2025
    Manufacturer
    FERRING PHARMACEUTICALS INC.
    Product Code
    MOZ
    PMA / PMN Number
    PMA P010029¿
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    SEVERE KNEE INFECTIONS [ARTHRITIS BACTERIAL]. CASE NARRATIVE: THIS IS A SERIOUS, SPONTANEOUS CASE RECEIVED FROM A PHYSICIAN IN AUSTRALIA. THIS REPORT CONCERNS FOUR PATIENTS, UNKNOWN AGE AND GENDER, WHO EXPERIENCED SEVERE KNEE INFECTION DURING TREATMENT WITH EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION, UNKNOWN CONCENTRATION, ROUTE AND DOSE FOR AN UNKNOWN INDICATION. LOT NUMBER AND EXPIRATION DATE WERE NOT AVAILABLE. THIS CASE DESCRIBE FIRST PATIENT OUT OF FOUR PATIENTS. ON AN UNKNOWN DATE, THE PHYSICIAN REPORTED THAT HE HAD TREATED FOUR PATIENTS IN THE PAST TWO YEARS WHO DEVELOPED SEVERE KNEE INFECTIONS FOLLOWING THE EUFLEXXA INJECTIONS. HE SAID THE INFECTIONS WERE DUE TO THE SYRINGE PICKING UP BACTERIA FROM A PATIENT'S SKIN AND TRANSPORTING IT INTO THEIR KNEES. ACTION TAKEN WITH EUFLEXXA WAS UNKNOWN. THE EVENT OF KNEE INFECTIONS WAS MEDICALLY SIGNIFICANT. AT THE TIME OF REPORTING, THE OUTCOME OF EVENTS WAS UNKNOWN. OVERALL LISTEDNESS (CORE LABEL) IS UNLISTED. REPORTER CAUSALITY: RELATED COMPANY CAUSALITY: RELATED REFERENCE IDS: INTERNAL # - OTHERS = AU1788 E2B LINKED REPORT = AU-FERRING PHARMACEUTICALS A/S-2025FE07215, E2B LINKED REPORT = AU-FERRING PHARMACEUTICALS A/S-2025FE07216, E2B LINKED REPORT = AU-FERRING PHARMACEUTICALS A/S-2025FE07221, E2B LINKED REPORT = AU-FERRING PHARMACEUTICALS A/S-2025FE07222, E2B LINKED REPORT = AU-FERRING PHARMACEUTICALS A/S-2025FE07223, AU-FERRING PHARMACEUTICALS A/S-2025FE07218, AU-FERRING PHARMACEUTICALS A/S-2025FE07217. CASE CORRECTION (B)(6) 2025: THE MANUFACTURER FOR EUFFLEXA HAS BEEN UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207858 EUFLEXXA 1%  SODIUM HYALURONATE MOZ FERRING PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O