BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2163563 · Received June 3, 2011

    Report

    Report Number
    2246315-2011-00130
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE 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

    PAIN RADIATED DOWN TO THIGH AND CALF/UNABLE TO SIT ON HARD SURFACE AND DRIVE [TORN MENISCUS] [PAIN EXTREMITY]. CANNOT STAND FOR MORE THAN A COUPLE OF MINUTES [TORN MENISCUS] [MOBILITY DECREASED]. TENDERNESS IN RIGHT THIGH AND CALF [TORN MENISCUS] [TENDERNESS]. RIGHT KNEE WARM [TORN MENISCUS] [JOINT WARMTH]. RIGHT KNEE SWOLLEN [TORN MENISCUS] [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6) WITH A TORN MENISCUS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED SYNVISC, 2 ML. ON (B)(6) 2011, THE PATIENT RECEIVED A SYNVISC INJECTION. FOURTEEN DAYS AFTER THIS INJECTION, THE PATIENT BEGAN HAVING PAIN THAT RADIATED DOWN TO HER THIGH AND CALF. THE PAIN WAS DESCRIBED AS EXCRUCIATING AND SHE COULD NOT STAND FOR MORE THAN A COUPLE OF MINUTES, WAS UNABLE TO SIT ON A HARD SURFACE, AND WAS UNABLE TO DRIVE. THE PATIENT'S RIGHT KNEE WAS SWOLLEN AND WARM, AND SHE HAD SOME TENDERNESS IN HER THIGH AND CALF. TREATMENT INCLUDED SYSTEMIC OR INTRA-ARTICULAR STEROID INJECTIONS. THE ACTION TAKEN WITH SYNVISC WAS NOT PROVIDED. THE PATIENT'S OUTCOME FOR THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS AS PROBABLY RELATED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 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.

    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 63 YR Required Intervention