BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1583373 · Received January 20, 2010

    Report

    Report Number
    2246315-2010-00010
    Event Type
    Other
    Date Received
    January 20, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 13, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# V0904, WITH EXPIRATION DATE 07/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    SWELLING OF THE RIGHT KNEE [JOINT SWELLING]. PAIN IN THE RIGHT KNEE [ARTHRALGIA]. RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A HEALTHCARE PROVIDER REGARDING A (B)(6) FEMALE PATIENT WITH A HISTORY OF OSTEOARTHRITIS OF THE KNEE, PREVIOUS SYNVISC INJECTIONS IN (B)(6) 2008 AND A PREVIOUS SYNVISC-ONE INJECTION IN (B)(6) 2009, INITIALS (B)(6), WHO EXPERIENCED PAIN AND SWELLING OF THE RIGHT KNEE AND RIGHT KNEE EFFUSION AFTER STARTING SYNVISC. THE PATIENT RECEIVED A SYNVISC-ONE INJECTION IN HER RIGHT KNEE ON (B)(6) 2009. THE HCP REPORTED THAT ON THE NIGHT OF THE INJECTION, THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE RIGHT KNEE WHICH CONTINUED TO WORSEN. ON (B)(6) 2009, 50 CC OF FLUID WAS ASPIRATED FROM THE RIGHT KNEE AND SENT FOR CULTURE. THE RESULTS OF THE CULTURE WERE NEGATIVE. THE GRAM STAIN WAS NEGATIVE AND WHITE BLOOD CELL COUNT (WBC) WAS 26,000. ON (B)(6) 2009, 50 CC OF FLUID WAS ASPIRATED FROM THE RIGHT KNEE. THE PATIENT RECEIVED A CORTISONE INJECTION ON (B)(6) 2009 AND THE SWELLING IN THE RIGHT KNEE HAD IMPROVED, BUT IT WAS STILL MORE PAINFUL THAN BEFORE SHE RECEIVED THE SYNVISC-ONE INJECTION. THE HCP REPORTED THAT THE EVENTS HAD A DEFINITE RELATION TO THE SYNVISC-ONE INJECTION. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PATIENT WAS UNKNOWN. THE LOT NUMBER WAS REPORTED TO BE V0904 WITH AN EXPIRATION DATE OF 07/2012. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2010 IN THE FORM OF QA RESULTS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# V0904, WITH EXPIRATION DATE 07/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT.

    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 V0904

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention