BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 7604267 · Received June 14, 2018

    Report

    Report Number
    9612392-2018-00009
    Event Type
    Injury
    Date Received
    June 14, 2018
    Report Date
    May 17, 2018
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P080020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON MAY 31, 2018. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS RECEIVED BY SEIKAGAKU CORPORATION ON MAY 31, 2018 AND THE PATIENT GAVE A CALL ON JUNE 13, 2018 AND AN E-MAIL ON JULY 24. MANUFACTURER ASSURED THAT THERE WAS NO QUALITY PROBLEM BASED ON THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING AND THE ENVIRONMENTAL MONITORING FOR LOT NO. 0017Y15G. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS RECEIVED BY SEIKAGAKU CORPORATION ON MAY 31, 2018 AND THE PATIENT GAVE A CALL ON JUNE 13, 2018. MANUFACTURER ASSURED THAT THERE WAS NO QUALITY PROBLEM BASED ON THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING AND THE ENVIRONMENTAL MONITORING FOR LOT NO. 0017Y15G. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Description of Event or Problem · 0

    ON (B)(6) 2018 A PATIENT HAD A GEL-ONE INJECTION IN BOTH KNEES. ON (B)(6) 2018 SUBSEQUENTLY THE PATIENT EXPERIENCED FACIAL SWELLING, SHORTNESS OF BREATH, FATIGUE AND OTHER UNKNOWN SYMPTOMS, (B)(6) 2018 OTHER TESTS HAD ALL COME BACK NEGATIVE.

    Description of Event or Problem · 0

    (B)(6) 2018 - A 49 YEAR-OLD FEMALE PATIENT HAD A GEL-ONE INJECTION IN BOTH KNEES. (B)(6) 2018 - THE PATIENT WAS UNABLE TO STRAIGHTEN HER LEFT KNEE. THE KNEE WAS SWOLLEN AND PAINFUL. IN A COUPLE OF WEEKS AFTER, THE PATIENT STARTED TO EXPERIENCE SWELLING OF THE EYELIDS, THEN OF THE ENTIRE FACE, SHORTNESS OF BREATH GOING UP STAIRS, FATIGUE AND FINGERS SWELLED. (B)(6) 2018 - THE SWELLING SUBSIDED BY AROUND MID-APRIL. IT WAS NOT CONSTANT (THE FACIAL, FINGERS - THE EYELID SWELLING WAS ALMOST CONSTANT, JUST THE DEGREE OF SWELLING CHANGED.) THE ALLERGIST TESTED THE PATIENT FOR POULTRY, FEATHERS, AND EGGS - ALL CAME BACK NEGATIVE. ACCORDING TO THE PATIENT ON (B)(6) 2018, SHE ALSO EXPERIENCED BLOOD PRESSURE WENT UP. (B)(6) 2018 - HER KNEE COULD FINALLY STRAIGHTEN ALMOST ALL THE WAY, WITH MINIMAL PAIN. SHE RECEIVED A CORTISONE INJECTION ON (B)(6) 2018, WHICH HELPED. SHE HAD PREVIOUSLY RECEIVED ORTHOVISC SHOTS REGULARLY FOR YEARS, AND DIDN'T HAVE THESE SYMPTOMS WITH THOSE.

    Description of Event or Problem · 0

    (B)(6) 2018 - A PATIENT HAD A GEL-ONE INJECTION IN BOTH KNEES. (B)(6) 2018 - SUBSEQUENTLY THE PATIENT EXPERIENCED FACIAL SWELLING, SHORTNESS OF BREATH, FATIGUE AND OTHER UNKNOWN SYMPTOMS. ACCORDING TO THE PATIENT, THE COMPLICATIONS LISTED BELOW ARE ALSO EXPERIENCED. LEFT KNEE COULD STRAIGHTEN. FINGERS SWELLED. BLOOD PRESSURE WENT UP. 2018-UNK - OTHER TESTS HAD ALL COME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443173 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00 0017Y15G

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other