BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2805515 · Received October 19, 2012

    Report

    Report Number
    2246315-2012-00324
    Event Type
    Other
    Date Received
    October 19, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 15, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2012. THE PRODUCT 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 THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    COULD BARELY WALK/USING A CANE TO WALK [GAIT DISTURBANCE]. KNEE STARTED TO SWELL/KNEE WAS SO SWOLLEN [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A MALE (PHYSICIAN'S ASSISTANT, AGE NOT PROVIDED) VIA SALES REPRESENTATIVE, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC AND EUFLEXXA (TWO TIMES). ON AN UNSPECIFIED DATE, IN (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, ROUTE NOT PROVIDED, AT A DOSE OF 2 ML, ONCE WEEKLY FOR THREE WEEKS, IN AN UNSPECIFIED KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT RECEIVED HIS SECOND SYNVISC INJECTION. ON (B)(6) 2012, WHEN THE PATIENT WOKE UP IN THE MORNING, HE EXPERIENCED THAT HIS KNEE HAD STARTED TO SWELL. LATER, BY THE AFTERNOON, THE PATIENT EXPERIENCED THAT HIS KNEE WAS SO SWOLLEN THAT HE COULD BARELY WALK. ON THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT HAD TO USE A CANE TO WALK. ON THE SAME DAY, 100 CC OF FLUID WAS ASPIRATED FROM AN UNSPECIFIED KNEE AND THE PATIENT RECEIVED TREATMENT WITH STEROID. THE PATIENT RECOVERED FROM THE EVENT OF COULD BARELY WALK/USING A CANE TO WALK AND DID NOT RECOVER FROM THE EVENTS OF KNEE SWELLING AND JOINT EFFUSION. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING HEALTH CARE PROFESSIONAL DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention