BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML

    MDR report key: 1695256 · Received May 18, 2010

    Report

    Report Number
    2246315-2010-00097
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 26, 2010
    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

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT. EVAL SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # S09041, WITH EXP DATE 03/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    TIGHTNESS IN LEFT KNEE [JOINT STIFFNESS]. PRESSURE IN BOTH KNEES [SENSATION OF PRESSURE]. SWELLING IN BOTH KNEES [JOINT SWELLING]. FLUID BUILD UP IN BOTH KNEES [JOINT EFFUSION]. THROBBING PAIN IN RIGHT KNEE [ARTHRALGIA]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM A (B)(6) MALE PT, INITIALS (B)(6), WHO EXPERIENCED SWELLING IN BOTH KNEES, FLUID BUILD UP IN BOTH KNEES, PRESSURE IN BOTH KNEES, TIGHTNESS IN THE LEFT KNEE, AND RIGHT KNEE PAIN AFTER TREATMENT WITH SYNVISC ONE. THE PT HAD A HISTORY OF PREVIOUS TREATMENT WITH SYNVISC IN APPROXIMATELY (B)(6) 2009. ON (B)(6) 2010, THE PT RECEIVED SYNVISC ONE (IT WAS REPORTED THAT BOTH KNEES WERE BEING TREATED, BUT UNCLEAR IF BOTH KNEES WERE INJECTED ON THIS DATE). ON (B)(6) 2010, THE PT EXPERIENCED SWELLING, TIGHTNESS, AND A LOT OF PRESSURE IN THE LEFT KNEE. ON AN UNK DATE, A CORTICOSTEROID INJECTION WAS ADMINISTERED AND THE SWELLING DECREASED ABOUT TWO DAYS LATER. ON AN UNSPECIFIED DATE, SWELLING AND FLUID BUILD UP IN THE LEFT KNEE RECURRED. ON (B)(6) 2010, THE PT EXPERIENCED SIGNIFICANT SWELLING, FLUID BUILD UP, AND PRESSURE IN THE RIGHT KNEE. ON (B)(6) 2010, THE PT RETURNED TO HIS PHYSICIAN'S OFFICE AND RECEIVED A CORTICOSTEROID INJECTION IN THE RIGHT KNEE. IT WAS REPORTED THAT THIS HELPED FOR A TIME, BUT THE SWELLING AND FLUID BUILD UP HAD RETURNED. THE PT ALSO REPORTED THAT HE IS EXPERIENCING A CONSTANT, THROBBING PAIN IN HIS RIGHT KNEE. AT THE TIME OF THIS REPORT, THE PT HAD NOT YET RECOVERED. ADDITIONAL INFO IN THE FORM OF QA RESULTS WAS RECEIVED ON (B)(4) 2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# S09041, WITH EXP DATE 03/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK S09041

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention