BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1200372 · Received October 10, 2008

    Report

    Report Number
    2246315-2008-00149
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    July 12, 2008
    Report Date
    September 22, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMAP940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# P0806, WITH EXPIRATION DATE (01/2011) WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    LEFT KNEE STIFFNESS [JOINT STIFFNESS]. SWELLING IN LEFT KNEE [JOINT SWELLING]. LEFT KNEE PAIN [ARTHRALGIA]. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B) (6) 2008, FROM A PHYSICIAN REGARDING A (B) (6) MALE PATIENT, INITIALS (B) (6), WHO HAD AN UNKNOWN RELEVANT MEDICAL HISTORY. THE PATIENT RECEIVED 2 INJECTIONS OF SYNVISC (LOT# P0806) IN THE LEFT KNEE ON UNKNOWN DATES. ONE DAY AFTER THE PATIENT'S SECOND INJECTION, HE EXPERIENCED LEFT KNEE SWELLING, STIFFNESS, AND PAIN. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED ON (B) (6) 2008, FROM THE TREATING PHYSICIAN. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS UPDATED TO INCLUDE: MODERATE GRADE OF OA (OSTEOARTHRITIS) IN THE LEFT PATELLOFEMORAL JOINT FOR A DURATION OF "YEARS", JOINT NARROWING, OSTEOPHYTES, PREVIOUS TREATMENT WITH NSAID'S, AND 3 PREVIOUS SERIES OF SYNVISC INJECTIONS. THE PATIENT RECEIVED HIS MOST RECENT SERIES OF SYNVISC INJECTION TO THE LEFT KNEE ON (B) (6) 2008, WITH NO EFFUSION COLLECTED BEFORE THE INJECTION. THE PATIENT RECEIVED HIS SECOND SYNVISC INJECTION IN THE LEFT KNEE ON (B) (6) 2008, WITH NO EFFUSION COLLECTED BEFORE THE INJECTION. STARTING ON (B) (6) 2008, THE PATIENT EXPERIENCED: LEFT KNEE SWELLING, LEFT KNEE STIFFNESS, AND LEFT KNEE PAIN. ON (B) (6) 2008, THE PHYSICIAN DRAINED 50 CC OF FLUID FROM THE PATIENT'S LEFT KNEE. ANALYSIS OF THE DRAINED FLUID WAS NOT PERFORMED. ON (B) (6) 2008, THE PHYSICIAN ALSO ADMINISTERED A 1CC INJECTION OF 80 MG/ML DEPO-MEDROL AS TREATMENT FOR THE EVENTS. THE PHYSICIAN REPORTED THE RELATION OF THE "LEFT KNEE SWELLING" TO SYNVISC AS DEFINITE, BUT DID NOT PROVIDE A CAUSALITY FOR THE OTHER EVENTS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THE QA INVESTIGATION RESULTS WERE RECEIVED ON (B) (6) 2008. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# P0806, WITH EXPIRATION DATE (01/2011) WERE 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 (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK P0806

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention