BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1235221 · Received November 13, 2008

    Report

    Report Number
    2246315-2008-00164
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    August 25, 2008
    Report Date
    October 23, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE QA INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2008. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER R07054, EXPIRATION DATE 04/2010 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONCORDANCES WERE NOTED.

    Description of Event or Problem · 1

    BLACK PATCHES ON SKIN OF KNEE [SKIN DISCOLOURATION]. LEFT KNEE SWELLING [JOINT SWELLING]. LEFT KNEE PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2008, FROM A PHYSICIAN REGARDING A PATIENT OF UNKNOWN INITIALS, AGE, AND RELEVANT MEDICAL HISTORY. THE PATIENT RECEIVED A SYNVISC ONE INJECTION, IN AN UNKNOWN JOINT IN (B)(6) 2008. AFTER 3 WEEKS, THE PATIENT EXPERIENCED KNEE SWELLING. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM A TREATING PHYSICIAN ON (B)(6) 2008. THE PATIENT IS A (B)(6) FEMALE, INITIALS (B)(6). RELEVANT MEDICAL HISTORY WAS NOT PROVIDED. SHE RECEIVED A SINGLE 6 ML INJECTION OF SYNVISC ONE, LOT # R07054, IN BOTH KNEES ON (B)(6) 2008. THREE WEEKS AFTER THE INJECTION ON (B)(6) 2008, SHE EXPERIENCED LEFT KNEE SWELLING AND PAIN. ON (B)(6) 2008, THE PATIENT DEVELOPED BLACK PATCHES ON THE SKIN OF THE KNEE. THE REPORTED INTENSITY OF THE EVENTS WAS MILD. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008, AFTER WHICH THE SWELLING AND PAIN COMPLETELY "SETTLED DOWN". CONCOMITANT MEDICATIONS INCLUDED: METFORMIN (500 MG, 2/DAY), DIAMECRON (DIAMICRON), LEVOTHYRENE (LEVOTHYRINE; 0.1 MG), ATORVASTATIN (20MG/DAY), RALAXIFENE HCI (RALOXIFENE HCI; 60 MG/DAY), MECOBALAMIN (500 MG, 3/DAY), CALCITIOL (CALCITRIOL; 0.25 MG/DAY), GABAPENTIN (300 MG, 2/DAY), CALCIUM LACTATE (300 MG, 3/DAY), CELEBRAX (CELEBREX; 200 MG, 2/DAY), DETEMIR (1 INJECTION IN THE MORNING), AND NOVARAPID (NOVORAPID; 2 INJECTIONS IN THE EVENING). AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME FOR THE LEFT KNEE SWELLING AND PAIN WAS RECOVERED WITH SEQUELAE, WITH THE SEQUELAE BEING BLACK PATCHES ON SKIN, WHICH CONTINUED. AS OF (B)(6) 2008, THE PATIENT WAS STILL IN THE HOSPITAL JUST WITH BLACK PATCHES ON THE SKIN OF THE KNEE. THE PATIENT HAS SEEN 2 DIFFERENT DOCTORS DURING HER COURSE: 1 DOCTOR WHO GAVE HER THE SYNVISC INJECTION, AND A DIFFERENT DOCTOR WHO SAW HER REGARDING HER EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK R07054

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization INSULIN DETEMIR (INSULIN DETEMIR) INJECTION| ATORVASTATIN (ATORVASTATIN)| MECOBALAMIN (MECOBALAMIN)| NOVORAPID (INSULIN ASPART) INJECTION| CELEBREX (CELECOXIB)| CALCIUM LACTATE (CALCIUM LACTATE)| GABAPENTIN (GABAPENTIN)| CALCITRIOL (CALCITRIOL)| METFORMIN (METFORMIN)| RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE| LEVOTHYRINE| DIAMICRON (GLICLAZIDE)