BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3122622 · Received May 15, 2013

    Report

    Report Number
    2246315-2013-00328
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    EXTREME STIFFNESS IN BOTH KNEES [JOINT STIFFNESS]; SWELLING IN BOTH KNEES TO TWICE THEIR SIZE [JOINT SWELLING]; BILATERAL KNEE EFFUSION [JOINT EFFUSION]; WORST KNEE PAIN/STINGING/BURNING [ARTHRALGIA] COULD NOT WALK/NOT COMFORTABLE WALKING/WALK WITH CRUTCHES [ABASIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH CALCIUM PYROPHOSPHATE DEPOSITION ARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR ORTHOSCOPIC SURGERY OF RIGHT KNEE, TORN MENISCUS, PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC ONE (IN (B)(6) 2005) AND SWELLING. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, 2 ML, IN BOTH KNEES (ROUTE OF ADMINISTRATION AND FREQUENCY NOT PROVIDED). THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE OF (B)(6) 2003, THE PATIENT EXPERIENCED KNEE EFFUSION AND HER HEALTH CARE PROFESSIONAL (HCP) DRAINED UNKNOWN AMOUNT OF FLUID OUT OF BOTH KNEES. ON (B)(6) 2013, AT 9:00 AM, THE PATIENT RECEIVED SECOND INJECTION OF SYNVISC. ON THE SAME DAY, AT 3:00 PM, THE PATIENT EXPERIENCED SWELLING IN BOTH KNEES TO TWICE THEIR SIZE AND THE PATIENT WAS NOT ABLE TO WALK FROM THE CAR TO INSIDE. IT WAS REPORTED THAT THE PATIENT GOT CRUTCHES FOR TWO DAYS. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT DEVELOPED KNEE PAIN WHICH WAS DESCRIBED BY THE PATIENT AS STINGING, BURNING AND THE WORST PAIN SHE HAS HAD. THE PATIENT ALSO DEVELOPED EXTREME STIFFNESS OF KNEES. THE PATIENT'S HCP DID NOT REMOVE ANY FLUID AFTER THE SECOND INJECTION AS HE DID NOT THINK THAT PATIENT'S BOTH KNEES WERE INFLAMED. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH PREDNISONE FOR THE EVENTS OF SWELLING IN BOTH KNEES, KNEE STIFFNESS, BILATERAL KNEE EFFUSION AND WORST KNEE PAIN/STINGING/BURNING. THE PATIENT REPORTED THAT SHE WAS NOT COMFORTABLE IN WALKING AFTER FINISHING THE PREDNISONE PACK. THE PATIENT'S THIRD INJECTION WAS DUE ON THE (B)(6) 2013 BUT HER HCP POSTPONED IT FOR A WEEK. THE OUTCOME FOR THE EVENTS OF EXTREME STIFFNESS IN BOTH KNEES, SWELLING IN BOTH KNEES TO TWICE THEIR SIZE, BILATERAL KNEE EFFUSION, WORST KNEE PAIN/STINGING/BURNING AND COULD NOT WALK/NOT COMFORTABLE WALKING/WALK WITH CRUTCHES WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE CAUSALITY BETWEEN SYNVISC AND ALL THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214842 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention