BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1848997 · Received September 21, 2010

    Report

    Report Number
    2246315-2010-00191
    Event Type
    Other
    Date Received
    September 21, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 21, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER X0903, EXPIRY DATE 09/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    ALLERGIC REACTION [HYPERSENSITIVITY]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A CONSUMER, INITIALS (B)(6), WITH UNK MEDICAL HISTORY. THE PT WAS ADMINISTERED SYNVISC-ONE IN HIS RIGHT KNEE ON AN UNK DATE IN (B)(6) 2009. HE DID NOT EXPERIENCE ANY ADVERSE EFFECTS FOR EIGHT MONTHS. HE RECEIVED A SECOND SYNVISC-ONE INJECTION ON (B)(6) 2010 IN HIS RIGHT KNEE. THE NEXT DAY, HE EXPERIENCED A SWOLLEN KNEE. HE STATED THAT HIS PHYSICIAN TOLD HIM HE HAD AN "ALLERGIC REACTION TO SYNVISC". HIS KNEE WAS DRAINED ON (B)(6) 2010 (108 CC), (B)(6) 2010 (66 CC), AND (B)(6) 2010 (35 CC). AT THE TIME OF THIS REPORT, THE OUTCOME OF THE REPORTED EVENTS AND TREATMENT WERE UNK. THE SYNVISC-ONE LOT NUMBER WAS NOT PROVIDED. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO WAS RECEIVED ON 09/14/2010 FROM THE PHYSICIAN. THE (B)(6) MALE, PT, INITIALS (B)(6), HAD A HISTORY OF MODERATE OSTEOARTHRITIS IN HIS RIGHT KNEE FOR A DURATION OF EIGHT YRS, PRIOR EFFUSION, JOINT NARROWING, AND PREVIOUS USE OF SYNVISC AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). THE PT HAD NO HISTORY OF OSTEOPHYTES. THE PT WAS TREATED WITH SYNVISC-ONE ON (B)(6) 2010. EFFUSION WAS NOT COLLECTED PRIOR TO THE INJECTION. THE SWOLLEN KNEE ONSET DATE WAS (B)(6) 2010. TREATMENT INCLUDED KNEE ASPIRATION ON (B)(6) 2010 (80 ML), (B)(6) 2010 (60 ML), AND (B)(6) 2010 (35 ML). STEROID TREATMENT WAS INITIATED ON (B)(6) 2010. A SYNOVIAL FLUID CULTURE FROM THE RIGHT KNEE WAS PERFORMED ON (B)(6) 2010. MICROSCOPY SHOWED NO PUS CELLS OR ORGANISMS WERE SEEN AND THE CULTURE SHOWED NO GROWTH. THE ANALYSIS CONSISTED OF THE FOLLOWING RESULTS: APPEARANCE SLIGHTLY CLOUDY, STRAW-COLORED, VISCOUS, LEUKOCYTES 7.3 X 10^9/L, ERYTHROCYTE 30 X 10^9/L, 85% MONONUCLEAR CELLS, AND 15% POLYMORPHONUCLEAR CELLS. NO ADDITIONAL LABS WERE PERFORMED. THE RELATION OF THE EVENTS OF KNEE SWOLLEN AND KNEE EFFUSION TO SYNVISC-ONE INJECTION WAS DEFINITE. THE INTENSITY OF BOTH SYMPTOMS WAS SEVERE. THE EVENT OF SWOLLEN KNEE WAS RESOLVED ON (B)(6) 2010 AND THE EVENT OF KNEE ASPIRATION RESOLVED ON AN UNK DATE IN 2010. THE PHYSICIAN CONFIRMED THAT HE CALLED THESE EVENTS AN "ALLERGIC REACTION" AND STATED THAT THE EVENTS OF KNEE SWELLING AND KNEE EFFUSION WERE MANIFESTATIONS OF THAT DIAGNOSIS. THE PT DID NOT TAKE ANY CONCOMITANT MEDICATIONS DURING SYNVISC-ONE TREATMENT. THE SYNVISC-ONE LOT NUMBER WAS X0903. NO FURTHER INFO WAS PROVIDED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON 09/16/2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER X0903, EXPIRY DATE 09/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK X0903

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention