BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F20) INJECTION

    MDR report key: 1053299 · Received May 28, 2008

    Report

    Report Number
    2246315-2008-00080
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 1, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # W0707, WITH EXPIRATION DATE (08/2010) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS), EFFUSION IN LEFT KNEE [JOINT EFFUSION]. LEFT KNEE SWOLLEN [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT REC'D IN 2008 FROM A CO REPRESENTATIVE REGARDING A 61 YEAR OLD FEMALE PT, INITIALS L-K, WHO HAD A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS AND 2 PREVIOUS SETS OF 3 SYNVISC INJECTIONS (EXACT DATES UNAVAILABLE). THE PT REC'D HER THIRD INJECTION OF SYNVISC IN BOTH KNEES TWO DAYS PRIOR. ABOUT 10 HOURS AFTER THE INJECTION, SHE EXPERIENCED AN EFFUSION IN HER LEFT KNEE. HER LEFT KNEE WAS SWOLLEN TO ABOUT TWICE ITS SIZE, BUT WAS NOT RED OR HOT. AS OF THE DATE OF THE REPORT (ORIGINAL DATE), THE PATIENT'S LEFT KNEE WAS STILL SWOLLEN, BUT NO TREATMENT HAD BEEN REC'D. SHE WAS USING A BRACE. THE PT IS A NURSE PRACTITIONER AND DID NOT FEEL THAT SHE NEEDED TO SEE HER DR. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS UNKNOWN. QA REPORT WAS REC'D FOUR DAYS LATER. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #W0707, WITH EXPIRATION DATE (08/2010) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. ADDITIONAL INFO WAS REC'D ON 05/22/2008 FROM THE TREATING PHYSICIAN (RHEUMATOLOGIST). HE UPDATED THE PT'S RELEVANT MEDICAL HISTORY TO INCLUDE: MODERATE GRADE OF OSTEOARTHRITIS (OA) FOR A DURATION OF 5 YEARS, OSTEOPHYTES, PREVIOUS TREATMENT WITH NSAIDS, AND PREVIOUS TREATMENT WITH STEROIDS. HE ALSO CONFIRMED THAT THE PT HAS REC'D SYNVISC IN THE PAST (DATES NOT SPECIFIED). THE PT REC'D HER SYNVISC INJECTIONS (LOT # W0707, EXP. 08-2010) IN BOTH KNEES ON THE FOLLOWING DATES: THREE TIMES IN THE SAME MONTH. NO EXUDATE WAS COLLECTED AFTER THE LAST INJECTION. THE PHYSICIAN CONFIRMED THAT THE PT EXPERIENCED THE EVENTS "EFFUSION IN LEFT KNEE" AND "LEFT KNEE SWOLLEN". THE ONSET DATE FOR BOTH SYMPTOMS WAS THE PREVIOUS MONTH. TREATMENT WITH STEROID INJECTIONS WAS REQUIRED FOR THE SYMPTOMS AND THE INJECTIONS WERE ADMINISTERED ON THE DAY AFTER THE ORIGINAL DATE. THE PT HAS RECOVERED FROM BOTH EVENTS, ALTHOUGH THE RECOVERY DATE WAS NOT SPECIFIED. THE HCP REPORTED THE RELATION OF BOTH EVENTS TO THE SYNVISC INJECTIONS AS "DEFINITE". AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK W0707

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention