BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2112448 · Received March 28, 2011

    Report

    Report Number
    2246315-2011-00058
    Date Received
    March 28, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 4, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Q1005, EXPIRY DATE 02/01/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    MASSIVE JOINT EFFUSION IN THE RIGHT/LEFT KNEE [JOINT EFFUSION]. LEFT KNEE SLIGHTLY SWOLLEN [JOINT SWELLING]. ALLERGIC REACTION [HYPERSENSITIVITY]. MEDIAL/LATERAL CONDYLARY CHONDROPATHY STAGE II [CHONDROPATHY]. BAKER CYST [SYNOVIAL CYST]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM AN ORTHOPEDIC SURGEON REGARDING A (B)(6) FEMALE PT, INITIAL UNK, WITH A MEDICAL HISTORY OF DOUBLE-SIDED ARTHROSIS AND PREVIOUS TREATMENT WITH SYNVISC IN 2009. THE PT WAS ADMINISTERED SYNVISC-ONE ON AN UNK DATE IN BOTH KNEES. AFTER THE INJECTION, SHE SUFFERED FROM A MASSIVE JOINT EFFUSION IN THE RIGHT KNEE. THE EFFUSION WAS PUNCTURED AND STERILE. THE SURGEON ASSUMED THAT IT MIGHT HAVE BEEN AN ALLERGIC REACTION BECAUSE THE PT'S LEFT KNEE WAS ALSO SLIGHTLY SWOLLEN. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE REPORTED EVENTS WAS UNK. SYNVISC-ONE LOT NUMBER WAS Q1005, EXPIRATION DATE 02/2013. NO FURTHER INFO WAS PROVIDED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2011. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Q1005, EXPIRY DATE 02/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. ADDITIONAL INFO WAS RECEIVED FROM THE REPORTING SURGEON REGARDING PT INITIALS (B)(6) WITH A MEDICAL HISTORY OF MODERATE GONARTHROSIS X-RAY GRADE II, KNOWN SINCE (B)(6) 2008, PRIOR EFFUSION, JOINT NARROWING, NMR (NUCLEAR MAGNETIC RESONANCE) TOMOGRAPHY ON (B)(6) 2009 WHICH SHOWED A LATERAL MENISCUS TEAR OF ANTERIOR HORN AT LOW DEGREE OF VALGUS GONARTHROSIS AND RETRO PATELLAR ARTHROSIS THIRD DEGREE, LOW DEGREE OF REACTIVE EFFUSION, AND PREVIOUS NSAIDS USE. THE PT DID NOT HAVE PREVIOUS HISTORY OF OSTEOPHYTES OR STEROID USE. THE PT RECEIVED SYNVISC-ONE ON (B)(6) 2011 IN BOTH KNEES. EFFUSION WAS NOT COLLECTED PRIOR TO THE SYNVISC-ONE INJECTION, HOWEVER, IT WAS COLLECTED ON (B)(6) 2011. MICROSCOPY REVEALED "SPORADIC" LEUKOCYTES AND BACTERIA NEGATIVE. RESULTS OF THE CULTURE AND ANAEROBIC CULTURE SHOWED NO GROWTH OF GERMS. ON (B)(6) 2011, THE PT EXPERIENCED MASSIVE JOINT EFFUSION IN THE RIGHT KNEE. TREATMENT INCLUDED AN ANTIPHLOGISTIC STEROID. ON (B)(6) 2011, EXUDATE OF 60 ML WAS COLLECTED VIA INTRA-ARTICULAR ROUTE FROM THE RIGHT KNEE AND WAS FOUND TO BE CLEAR AND SEROUS. THE PT ALSO EXPERIENCED LEFT KNEE SWELLING AND EFFUSION IN THE LEFT KNEE. ON (B)(6) 2011, 30 ML OF EXUDATE WAS COLLECTED FROM THE LEFT KNEE AND WAS FOUND TO BE CLEAR AND SEROUS. THE MICROSCOPY SHOWED LOTS OF LEUKOCYTES AND BACTERIA WAS NEGATIVE. RESULTS OF THE CULTURE AND ANAEROBIC CULTURE WAS NO GROWTH OF GERMS. THIS EVENT WAS ALSO TREATED WITH STEROIDS. ALL RESULTS WERE STERILE. NMR TOMOGRAPHY WAS PERFORMED ON (B)(6) 2011. THE EVAL REVEALED BAKER CYST AND ARTHROSIS WITH MENISCOPATHY, ENCAPSULATED LATERAL EFFUSION WITH IRRITATION IN THE AREA OF THE ROOT OF THE POPLITEAL/BICEPS-FEMORAL TENDON AT HISTORY OF INJECTION, LIGAMENTS INTACT, AND MEDIAL AND LATERAL CONDYLAR CHONDROPATHY STAGE II AS WELL AS THIRD DEGREE OF CHONDROPATHY PATELLAR WITH REACTIVE EFFUSION. THE OUTCOME OF MASSIVE JOINT EFFUSION IN THE RIGHT KNEE AND ALLERGIC REACTION WERE UNK AS THE PT HAD CHANGED PHYSICIANS. THE RELATION TO SYNVISC AND THE EVENTS OF RIGHT KNEE JOINT EFFUSION AND ALLERGIC REACTION WERE DEEMED "PROBABLE" AND THE INTENSITY OF BOTH EVENTS WERE "MODERATE". NO FURTHER INFO WAS PROVIDED.

    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 Q1005

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other