BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2265204 · Received September 22, 2011

    Report

    Report Number
    2246315-2011-00224
    Event Type
    Other
    Date Received
    September 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    September 13, 2011
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    BEDRIDDEN [BEDRIDDEN]. SWOLLEN KNEES [JOINT SWELLING] NOT ABLE TO WALK [ABASIA]. TEST FOR "IMPLAMMATION" FOUR TIMES GREATER THAN NORMAL [INFLAMMATORY MARKER INCREASED] UNABLE TO BEND KNEES [JOINT RANGE OF MOTION DECREASED]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2011, FROM AN MRI (MAGNETIC RESONANCE IMAGING) TECHNOLOGIST REGARDING A (B)(6) FEMALE PT WITH ARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED SYNVISC-ON, 6 ML BOTH KNEES WITH DEXAMETHASONE ALSO GIVEN VIA INTRA-ARTICULAR ROUTE, UNDER FLUOROSCOPY. (B)(6) DAYS AFTER RECEIVING SYNVISC-ONE THE PT HAD SWOLLEN KNEES, SHE WAS UNABLE TO BEND THEM, NOT ABLE TO WALK, AND WAS BEDRIDDEN FOR A FEW DAYS. THE SWELLING WAS THE SIZE OF A SOFTBALL. SHE HAD AN UNSPECIFIED TEST FOR INFLAMMATION PERFORMED WHICH WAS FOUR TIMES GREATER THAN NORMAL. (B)(6) WEEKS LATER, THE PT HAD A LEFT KNEE MRI. (B)(6) DAYS AFTER THE MRI, THE PT WAS SEEN IN THE EMERGENCY ROOM FOR SWELLING. SHE WAS GIVEN NSAIDS (NONSTEROIDAL ANTI-INFLAMMATORY DRUGS) AND TOLD TO USE CRUTCHES. THE PT WAS TO HAVE HER RIGHT KNEE SCANNED ON THE DAY OF THIS REPORT. THE SWELLING WAS BETTER IN BOTH KNEES. MRI FILMS ARE AVAILABLE. THE ACTION TAKEN WITH SYNVISC-ONE WAS NOT PROVIDED. THE PT'S OUTCOME FOR THE EVENT OF SWELLING WAS NOT YET RECOVERED. THE PT'S OUTCOME FOR THE REMAINING EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. 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. 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 CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R