BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1220544 · Received November 3, 2008

    Report

    Report Number
    2246315-2008-00158
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 20, 2008
    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

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# PO822, EXPIRY DATE 02/2011 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    RIGHT KNEE EFFUSION [JOINT EFFUSION]; KNEE SWELLING [JOINT SWELLING]; RIGHT KNEE PAIN [ARTHRALGIA]; UNABLE TO SLEEP [INSOMNIA]; COULD NOT WALK [ABASIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 20-OCT-2008 FROM A (B) (6) FEMALE WITH A HISTORY OF ARTHRITIS, LEFT TOTAL KNEE REPLACEMENT ON (B) (6) 2008 AND PREVIOUS TREATMENT WITH SYNVISC AND ORTHOVISC, (B) (6), WHO EXPERIENCED RIGHT KNEE PAIN, RIGHT KNEE SWELLING, UNABLE TO SLEEP, COULD NOT WALK AND RIGHT KNEE EFFUSION AFTER STARTING SYNVISC. THE PATIENT RECEIVED THE FIRST INJECTION OF SYNVISC INTO THE RIGHT KNEE ON (B) (6) 2008. SHE EXPERIENCED "A LITTLE BIT" OF KNEE PAIN AND SWELLING AFTER THAT INJECTION THAT RESOLVED AFTER TREATMENT WITH ICE. SHE RECEIVED THE SECOND INJECTION INTO THE RIGHT KNEE ON (B) (6) 2008 AND AGAIN EXPERIENCED PAIN AND SWELLING POST-INJECTION. THE NIGHT, SHE WAS UNABLE TO SLEEP AND FOUND SHE COULD NOT WALK WHEN SHE ATTEMPTED TO ON THE MORNING OF (B) (6) 2008. SHE WAS SEEN BY THE INJECTING PHYSICIAN ON (B) (6) 2008, WHO WITHDREW FLUID AND INJECTED A CORTISONE SHOT. AS OF THE DATE OF THIS REPORT, THE EVENTS OF PAIN AND SWELLING HAD IMPROVED, BUT NOT RESOLVED. THE OUTCOME OF THE EVENTS UNABLE TO SLEEP AND UNABLE TO WALK WAS UNKNOWN AND THE EVENT RIGHT KNEE EFFUSION WAS RECOVERED. ADDITIONAL INFORMATION IN THE FORM OF A QA REPORT WAS RECEIVED 22-OCT-2008. QA RESULTS: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# PO822, EXPIRY DATE 02/2011 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. (B) (4).

    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 P0822

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention