BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJFECTION

    MDR report key: 1081622 · Received July 25, 2008

    Report

    Report Number
    2246315-2008-00108
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 18, 2008
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    LEFT KNEE SWELLING [JOINT SWELLING]. LEFT KNEE PAIN [ARTHRALGIA]. DIZZINESS [DIZZINESS]. HEADACHE [HEADACHE]. NAUSEA [NAUSEA]. EFFUSION (LEFT KNEE) [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT REC'D ON 06/18/08 FROM A (B) (6) FEMALE PT, (B) (6), WHO HAD A RELEVANT MEDICAL HISTORY OF WORN CARTILAGE, OSTEOARTHRITIS OF THE LEFT KNEE, AND A PREVIOUS COURSE OF SYNVISC THERAPY IN THE RIGHT KNEE IN (B) (6) 2007. THE PT REC'D HER MOST RECENT SYNVISC INJECTIONS IN HER LEFT KNEE ON (B) (6) 2008, (B) (6) 2008, (B) (6) 2008. SINCE RECEIVING THE INJECTIONS, SHE HAS EXPERIENCED PAIN AND SWELLING IN THE LEFT KNEE. SHE HAS ALSO EXPERIENCED "FLU-LIKE" SYMPTOMS, SPECIFICALLY HEADACHE, NAUSEA, AND DIZZINESS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS NOT YET RECOVERED. ADDITIONAL INFO WAS REC'D ON 07/21/08 FROM THE TREATING PHYSICIAN. HE UPDATED THE PT'S RELEVANT MEDICAL HISTORY TO INCLUDE: MODERATE GRADE OF OSTEOARTHRITIS IN THE LEFT KNEE, RIGHT KNEE PAIN, ARTHROSCOPIC SURGERY OF THE RIGHT KNEE (APPROX 1980), SEVERE PATELLOFEMORAL COLLAPSE AND ARTHROSIS WITH BILATERAL SUBLUXATION (RIGHT GREATER THAN LEFT ON MERCHANT VIEWS) AND POSSIBLE INTERNAL DERANGEMENT OF MEDIAL COMPARTMENT, MEDIAL JOINT LINE TENDERNESS/GRADE 2 EFFUSION, RIGHT LATERAL RETINACULAR RELEASE (APPROX (B) (6) 2008), AND SIGNIFICANT DEGENERATIVE CHANGES ON THE UNDERSURFACE OF THE RIGHT PATELLA. HE CONFIRMED THAT THE PT REC'D HER MOST RECENT COURSE OF SYNVISC INJECTIONS IN THE LEFT KNEE ON THE FOLLOWING DATES: (B) (6) 2008, (B) (6) 2008, (B) (6) 2008. SHE HAD A LITTLE BIT OF EFFUSION AFTER THE FIRST INFECTION (NOTED PRIOR TO ADMINISTRATION OF SECOND INJECTION 06/05/08). THE PHYSICIAN CONFIRMED THAT THE PT EXPERIENCED THE EVENTS: LEFT KNEE SWELLING AND LEFT KNEE PAIN, WHICH REQUIRED TREATMENT WITH MEDROL. THE PT HAD RECOVERED FROM BOTH EVENTS (RECOVERY DATES NOT SPECIFIED). THE PHYSICIAN DID NOT CONFIRM THAT THE PT EXPERIENCED THE EVENTS: HEADACHE, NAUSEA, OR DIZZINESS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE OVERALL PT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJFECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention