BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION 2ML

    MDR report key: 1023860 · Received April 2, 2008

    Report

    Report Number
    2246315-2008-00046
    Event Type
    Other
    Date Received
    April 2, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# P07201 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    WALKING DISABILITY [GAIT DISTURBANCE]; PAIN AT TIME OF APPLICATION [INJECTION SITE PAIN]; EDEMA UP TO THE FOOT [OEDEMA PERIPHERAL]; CALF PAIN [ PAIN IN EXTREMITY]; KNEE PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 11-MAR-2008 FROM A PHYSICIAN REGARDING A MALE PATIENT, INITIALS SSM. THE PATIENT HAD A MEDICAL HISTORY OF BILATERAL GONARTHROSIS OF UNKNOWN JOINTS AND WAS CONCOMITANTLY TAKING ESTRUGERO FORTE AS WELL AS DOLO NEUROBION. THE PATIENT BEGAN RECEIVING SYNVISC ONCE A YEAR BEGINNING IN 2003. ON UNKNOWN DATES INTO UNKNOWN INJECTION SITES, THE PATIENT PRESENTED WITH INTENSE PAIN AT THE TIME OF THE FIRST APPLICATION OF SYNVISC. AFTER THE SECOND APPLICATION OF SYNVISC, THE PATIENT EXPERIENCED EDEMA UP TO THE FOOT AND CALF PAIN. THE EDEMA WAS TREATED WITH BARIUM. IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED. QA INVESTIGATION SUMMARY WAS RECEIVED ON 17-MAR-2008. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# P07201 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCE'S WERE NOTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-MAR-2008 FROM THE PHYSICIAN VIA A DISTRIBUTOR. HE REPORTED THAT THE PATIENT EXPERIENCED INTENSE PAIN AFTER THE FIRST ADMINISTRATION OF SYNVISC IN BOTH KNEES (WHICH OCCURRED IN 2008) AND OEDEMA ON HIS FOOT UNTIL HIS CALF AFTER THE SECOND INJECTION IN 2008. THE PHYSICIAN INDICATED BARIUM FOR THE EDEMA BUT THE PATIENT DID NOT SEE THE PHYSICIAN FOR TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 25-MAR-2008 FROM THE PHYSICIAN. HE REPORTED THAT THE PATIENT RECEIVED SYNVISC INTO HIS KNEE(S) TWO MONTHS EARLIER. THIS INJECTION WAS ASSOCIATED WITH SEVERE KNEE PAIN BUT HE DID NOT PROVIDE THE DATE THAT THIS EVENT OCCURRED. THE PATIENT THEN RECEIVED HIS SECOND INJECTION INTO BOTH KNEES AT THE END OF THE FOLLOWING MONTH, WHICH WAS ASSOCIATED TO SEVERE KNEE PAIN AND EDEMA BUT DID NOT PROVIDE THE DATE THAT THESE EVENTS OCCURRED. THE PATIENT ALSO PRESENTED WITH A WALKING DISABILITY BUT IT IS NOT KNOWN IF THIS WAS ASSOCIATED WITH THE FIRST OR SECOND INJECTIONS. THE PHYSICIAN PROVIDED THE INTENSITY OF THE EVENTS AS SEVERE AND NOTED THAT THERE WAS A PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY. THE PHYSICIAN NOTED TWO HYPOTHESES REGARDING THE CAUSE OF THE ADVERSE EVENTS. HE FELT THAT THEY MAY HAVE BEEN CAUSED BY EITHER "OLD DRUG" OR THAT THE PRODUCT WAS NOT STORED CORRECTLY REGARDING TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION 2ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK P07201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability