BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2696498 · Received August 10, 2012

    Report

    Report Number
    2246315-2012-00244
    Event Type
    Other
    Date Received
    August 10, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 2, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD0
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(6) 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. THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT. EVALUATION SUMMARY: 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.

    Description of Event or Problem · 1

    SWELLING OF LEFT KNEE [JOINT SWELLING]. LEFT KNEE PAIN [ARTHRALGIA]. JOINT EFFUSION [JOINT EFFUSION]. SWELLING [SWELLING]. PYREXIA [PYREXIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH GONARTHROSIS OF BOTH KNEES. ON (B)(6) 2010, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION (ROUTE NOT PROVIDED), 2 ML, 1X/W, INTO RIGHT KNEE. ON THE SAME DAY, SHE HAD HER X-RAY DONE (RESULTS NOT PROVIDED). ON (B)(6) 2012, THE PATIENT RECEIVED SECOND SYNVISC INJECTION INTO THE RIGHT KNEE AND FIRST SYNVISC (HYLAN G-F 20) INJECTION (ROUTE NOT PROVIDED), 2 ML, 1 X/W, INTO THE LEFT KNEE. ON (B)(6) 2012, THE PATIENT RECEIVED HER THIRD INJECTION INTO THE RIGHT KNEE AND SECOND INJECTION INTO THE LEFT KNEE. ON THE SAME DAY, SHE EXPERIENCED SWELLING WHICH RECOVERED RAPIDLY. ON (B)(6) 2012, THE PATIENT HAD HER THIRD INJECTION INTO THE LEFT KNEE. ON (B)(6) 2012, THE PATIENT EXPERIENCED SWELLING OF LEFT KNEE, PYREXIA AND LEFT KNEE PAIN. ON THE SAME DAY, 30ML OF CLEAR FLUID WAS ASPIRATED FROM THE LEFT KNEE (JOINT EFFUSION). THE PATIENT WAS GIVEN TREATMENT WITH BETAMETHASONE SODIUM PHOSPHATE AND LIDOCAINE FOR PAIN AND SWELLING FOLLOWING WHICH, THE PATIENT RECOVERED FROM THE EVENTS OF SWELLING OF LEFT KNEE, PYREXIA AND LEFT KNEE PAIN. THE OUTCOME FOR THE EVENT OF JOINT EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF SWELLING OF LEFT KNEE, PYREXIA AND LEFT KNEE PAIN AS DEFINITE AND DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF JOINT EFFUSION AND SWELLING.

    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 (RIDGEFIELD0 UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention