BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2222556 · Received August 16, 2011

    Report

    Report Number
    2246315-2011-00198
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL 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

    PAIN IN KNEE [ARTHRALGIA]. SWELLING IN KNEE [JOINT SWELLING]. USING CRUTCHES TO AMBULATE [MOBILITY DECREASED]. PAIN IN CALF [PAIN IN EXTREMITY]. DETERMINED NOT TO HAVE WORKED [DEVICE INEFFECTIVE]. TUMOR, NON-CANCER [BENIGN NEOPLASM]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A CONSUMER REGARDING A (B)(6) MALE PT, INITIALS (B)(6) WITH OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED SYNVISC-ONE, 6 ML IN THE RIGHT KNEE. SINCE RECEIVING THE SYNVISC-ONE INJECTION, THE PT HAS EXPERIENCED PAIN AND SWELLING IN THE KNEE AND PAIN IN THE CALF. THE ACTION TAKEN WITH SYNVISC-ONE WAS NOT PROVIDED. THE PT'S OUTCOME WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ADDITIONAL INFO RECEIVED ON (B)(4) 2011, FROM THE PT. HE STATED THAT HE CONTINUED TO HAVE SWELLING THIRTEEN DAYS AFTER RECEIVING THE SYNVISC-ONE INJECTION AND HE WAS USING CRUTCHES TO AMBULATE. THE QA (QUALITY ASSURANCE INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2011. 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. ADDITIONAL INFO RECEIVED ON (B)(4) 2011, FROM THE PT. PRIOR TO THE SYNVISC-ONE INJECTION ON AN UNSPECIFIED DATE, THE PHYSICIAN HAD ORDERED AN MRI (MAGNETIC RESONANCE IMAGING) OF THE RIGHT KNEE WHICH DID NOT SHOW ANY INDICATION OF A TUMOR. THE PT STATED THAT THE SYNVISC INJECTION ADMINISTERED ON AN UNSPECIFIED DATE IN (B)(4) 2011, DID NOT WORK AS THERE WAS CONTINUED SWELLING AND PAIN. ON (B)(4) 2011, A SCOPE WAS PERFORMED AND THE AREA WAS CLEANED OUT. DURING THE SURGERY, THE PHYSICIAN FOUND A TUMOR WHICH WAS NON CANCEROUS. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R