BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1080979 · Received July 22, 2008

    Report

    Report Number
    2246315-2008-00106
    Event Type
    Other
    Date Received
    July 22, 2008
    Date of Event
    February 6, 2008
    Report Date
    May 20, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# S0707, WITH EXPIRATION DATE (04/2010) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    COULD NO LONGER BEND OVER [MOBILITY DECREASED]. PAIN IN LEFT KNEE WORSE THAN BEFORE [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 05/20/2008 FROM A FEMALE PT WHO HAD A RELEVANT MEDICAL HISTORY OF OSTEOPOROSIS OF THE KNEE. THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS (LOT#: S0707, EXP DATE: 04/2010) IN THE LEFT KNEE ON THE FOLLOWING DATES: IN 2008. ABOUT 2 WEEKS AFTER THE THIRD INJECTION, SHE COULD NO LONGER BEND OVER AND THE PAIN IN HER LEFT KNEE WAS WORSE THAN BEFORE SHE RECEIVED THE SYNVISC. AS OF FOUR MONTHS LATER, THE PAIN CONTINUED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS NOT YET RECOVERED. THE QA INVESTIGATION RESULTS WERE RECEIVED ON 05/22/2008. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# S0707, WITH EXPIRATION DATE (04/2010) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. ADDITIONAL INFO WAS RECEIVED ON 07/17/2008 FROM THE TREATING PHYSICIAN. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS UPDATED TO INCLUDE: SEVERE GRADE OF OA (OSTEOARTHRITIS) IN THE LEFT KNEE FOR DURATION OF 3 YEARS, JOINT NARROWING, OSTEOPHYTES, PREVIOUS TREATMENT WITH NSAID'S, PREVIOUS TREATMENT WITH STEROIDS, AND PREVIOUS TREATMENT WITH SYNVISC. THE PT RECEIVED THE FIRST 2 INJECTIONS OF HER MOST RECENT COURSE OF SYNVISC THERAPY IN HER LEFT KNEE ON THE FOLLOWING DATES: IN EARLY 2008, THE FOLLOWING MONTH. NO EFFUSION WAS COLLECTED BEFORE EITHER INJECTION. ON THE SECOND DAY, THE PT EXPERIENCED THE SYMPTOMS "COULD NO LONGER BEND OVER" AND "PAIN IN LEFT KNEE WORSE THAN BEFORE". TREATMENT WITH A CORTISONE INJECTION WAS REQUIRED FOR THE SYMPTOMS A WEEK LATER. THE OFFSET DATE FOR THE SYMPTOMS WAS THE SAME DAY. THE PT RECEIVED HER THIRD SYNVISC INJECTION IN THE LEFT KNEE A WEEK LATER. NO EFFUSION WAS COLLECTED BEFORE THE INJECTION AND NO EXUDATE WAS COLLECTED AFTER THE INJECTION. THE PHYSICIAN REPORTED THE RELATION OF THE SYMPTOMS TO THE SYNVISC INJECTIONS AS PROBABLE. 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-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK S0707

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention