BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 7327240 · Received March 9, 2018

    Report

    Report Number
    9612392-2018-00003
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    November 8, 2017
    Report Date
    January 22, 2018
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. THIS CASE IS LISTED IN MAUDE DATABASE OF THE FDA SITE AS MW5074735. NO CONTACT INFORMATION WAS AVAILABLE. COMPANY COMMENT: THE POSITIVE STAPH INFECTION WAS CONSIDERED TO BE DEVELOPED DUE TO THE INJECTION PROCEDURE OR THE PATIENT'S CONDITION RATHER THAN THE PRODUCT QUALITY ISSUE, SINCE ALL OF PRODUCT BATCHES WERE ASSURED TO PASS WITH THE RELEASE TEST INCLUDING THE STERILITY TEST BEFORE THE PRODUCT RELEASE. THE CAUSALITY ASSESSMENT WAS THEREFORE DETERMINED "NOT RELATED". SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF BIOVENTUS LLC AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2016008.

    Description of Event or Problem · 0

    ON (B)(6) 2017 - A PATIENT RECEIVED A SERIES OF 5 SUPARTZ INJECTIONS TO THE LEFT KNEE FOR ARTHRITIS, ONE SHOT PER WEEK. THE PATIENT HAD RECEIVED THESE SHOTS PRIOR TO THIS EPISODE WITH NO PROBLEM. ON (B)(6) 2017 - A POSITIVE STAPH INFECTION OCCURRED WITHIN 36 HRS AFTER THE 5TH INJECTION WHICH WAS DIAGNOSED WITH EMERGENCY SURGERY REQUIRED. I.V. MEDS FOR 5 WEEKS WERE ADMINISTERED. ON (B)(6) 2018 -THE PATIENT STATED THE BLOOD TESTS STILL SHOWED ABNORMALITIES AND THE PATIENT STILL HAS BEEN UNABLE TO BARE WEIGHT OR WALK WITHOUT CANE/CRUTCHES. THE PATIENT STATED THE PAIN WAS UNBEARABLE AND THE PATIENT HAVE NEVER EXPERIENCED THIS TYPE OF LIFE CHANGING EVENT EVER. THE PATIENT FELT THE RECOVERY HAS BEEN A NIGHTMARE AND A VERY SLOW PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169470 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other