BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1012352 · Received February 12, 2008

    Report

    Report Number
    2246315-2008-00036
    Event Type
    Injury
    Date Received
    February 12, 2008
    Report Date
    February 15, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    RIGHT KNEE SWELLING [JOINT SWELLING], RIGHT KNEE BAKER'S CYST [SYNOVIAL CYST], EFFUSION RIGHT KNEE [JOINT EFFUSION], PAIN IN RIGHT KNEE [ARTHRALGIA], SURGERY (NOS) [SURGERY], FEVER [PYREXIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 15 FEB 2008, FROM A PHYSICIAN REGARDING A FEMALE CHONDROMALACIA PATIENT. THE PATIENT RECEIVED HER FIRST DOSE OF SYNVISC ON A MONTH EARLIER ADMINISTERED INTRA-ARTICULARLY AND HER LAST DOSE ON FOUR DAYS PRIOR TO ORIGINAL DATE. SHE RECEIVED 3 INJECTIONS WITHIN 3 WEEKS. THE PATIENT'S MEDICAL HISTORY IS NOT AVAILABLE. ON EIGHT DAYS PRIOR TO ORIGINAL DATE, APPROX 15 DAYS AFTER STARTING SYNVISC, THE PATIENT EXPERIENCED SWELLING, BAKER'S CYST, EFFUSION AND PAIN IN THE RIGHT KNEE THAT WAS CONSIDERED BY THE TREATING PHYSICIAN TO BE NON-SERIOUS. THESE SYMPTOMS IMPROVED WHEN THE PATIENT USED A COLD PACK ON THE KNEE. SYNVISC WAS WELL TOLERATED IN THE LEFT KNEE. THE TREATING PHYSICIAN NOTED THAT AFTER THE 2ND INJECTION (DATE NOT REPORTED), THE PATIENT FELL. IBUPROFEN 800 MG, 2 TABLETS PER DAY FOR 10 DAYS WAS PRESCRIBED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS RECOVERED. CONCOMITANT MEDICATIONS REPORTED INCLUDE IBU 800MG (IBUPROFEN). THE RELATIONSHIP BETWEEN RIGHT KNEE BAKER'S CYST/EFFUSION RIGHT KNEE/SWELLING RIGHT KNEE/PAIN RIGHT KNEE AND SYNVISC WAS ASSESSED AS NOT RELATED. ACCORDING TO THE TREATING PHYSICIAN, THERE WAS A DIFFERENT CLINICAL PICTURE, SO THAT NO SIDE EFFECTS IN THE CONTEXT OF SYNVISC APPLICATION WAS OBSERVED. ON 28-FEB-2008 THE QA RESULT WAS RECEIVED: 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. FOLLOW-UP INFO WAS RECEIVED ON 4 MARCH 2008 VIA THE COMPANY REP FROM THE PATIENT'S HUSBAND WHO REPORTED THAT HIS WIFE WAS IN HOSPITAL FOR 2 WEEKS DUE TO A SURGERY THAT BECAME NECESSARY DUE TO THE USE OF SYNVISC. THE EARLIER REPORTED SYMPTOMS (EFFUSION, SWELLING AND PAIN OF THE RIGHT KNEE) BECAME WORSE AND SHE SUFFERED FROM FEVER.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization