BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1040083 · Received May 7, 2008

    Report

    Report Number
    2246315-2008-00065
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 9, 2008
    Report Date
    April 23, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# X0717 / W0718 WERE REVIEWED. THE INVESTIGATION(S) SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    PSEUDOSEPTIC REACTION [ARTHRITIS], RIGHT KNEE PAIN [ARTHRALGIA], RIGHT KNEE SWELLING [JOINT SWELLING], RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: INITIAL INFO WAS RECEIVED ON 23-APR-2008 FROM PHYSICIAN. THE PT IS A FEMALE WITH A MEDICAL HISTORY OF OSTEOARTHRITIS. SHE RECEIVED AN UNSPECIFIED NUMBER OF SYNVISC INJECTIONS ON AN UNK DATE IN THE RIGHT KNEE. ABOUT A MONTH AGO, THE PT EXPERIENCED SEVERE PAIN AND SWELLING IN THE RIGHT KNEE. SHE ALSO EXPERIENCED A PSEUDOSEPTIC REACTION IN THE RIGHT KNEE AND SHE WAS ADMITTED TO THE HOSPITAL FOR 5 DAYS. PHYSICIAN CAUSALITY ASSESSMENT ON THE RELATIONSHIP ON THE EXPERIENCED EVENTS TO SYNVISC WAS PROBABLY RELATED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. NO FURTHER INFO PROVIDED. ADD'L INFO WAS RECEIVED ON 28-APR-2008 FROM PHYSICIAN. THE PT HAS A MEDICAL HISTORY OF OSTEOPOROSIS, PREVIOUS SPINAL FRACTURE, MILD MEDICAL COMPARTMENT/SEVERE PATELLAR-FEMORAL DEGENERATIVE JOINT DISEASE/OSTEOARTHRITIS. THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS IN THE RIGHT KNEE THREE MONTHS EARLIER, SEVEN DAYS LATER, AND THE FOLLOWING MONTH. THE PT ALSO RECEIVED A SERIES OF SYNVISC INJECTIONS IN THE LEFT KNEE "AROUND THE SAME TIME." LOT# X0717 WAS PROVIDED FOR SYNVISC INJECTIONS ADMINISTERED IN THE RIGHT KNEE AND LOT# W0718 WAS PROVIDED FOR SYNVISC INJECTIONS ADMINISTERED IN THE LEFT KNEE. THE PT EXPERIENCED RIGHT KNEE SWELLING AND KNEE PAIN. FOUR DAYS LATER, THE PT'S RIGHT KNEE WAS ASPIRATED WITH 40CC OF CLOUDY FLUID AND WAS SENT TO THE LAB FOR ANALYSIS. SHE WAS DIAGNOSED WITH A PSEUDOSEPTIC REACTION IN THE RIGHT KNEE AND ADMITTED TO THE HOSPITAL. LAB ANALYSIS OF SYNOVIAL FLUID INDICATED ABNORMAL WBC COUNT OF 8496, RBC COUNT OF 11000, AND A SEGMENTED NEUTROPHIL COUNT OF 51%. SYNOVIAL FLUID CULTURE WAS PERFORMED, REPEATED SEVERAL TIMES, AND RESULTED IN NO GROWTH. TWENTY-ONE DAYS LATER, FURTHER LAB ANALYSIS INDICATED THAT THE PT'S BLOOD CULTURE TESTED POSITIVE FOR COAG-NEGATIVE STAPH, BUT HCP WAS POSITIVE THAT THE SAMPLE WAS CONTAMINATED AND IT WAS UNRELATED TO SYNVISC. HCP CAUSALITY ASSESSMENT OF RELATEDNESS TO SYNVISC WAS: PROBABLE FOR KNEE EFFUSION, DEFINITE FOR PSEUDOSEPTIC REACTION, UNRELATED FOR POSITIVE COAG-NEGATIVE STAPH CULTURE, UNRELATED FOR KNEE PAIN, AND UNRELATED FOR KNEE SWELLING. THE PT HAS NOT YET FOLLOWED-UP WITH HCP AND AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. NO FURTHER INFO PROVIDED. QA RESULTS WERE RECEIVED ON 01-MAY-2008: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# W0718 (EXP. 09/2010) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. IN ADDITION, THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# X0717 (EXP. 10/2010) WAS 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 X0717 / W0718

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization