BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3132775 · Received May 24, 2013

    Report

    Report Number
    2246315-2013-00333
    Date Received
    May 24, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    SEPTIC REACTION IN LEFT KNEE [ARTHRITIS INFECTIVE]. PAIN IN LEFT KNEE [ARTHRALGIA]. SWELLING IN LEFT KNEE [JOINT SWELLING]. BLOODY EFFUSION IN LEFT KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6), 2013, FROM THE PHYSICIAN VIA SALES REP REGARDING (B)(6) FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT (SEVERAL TIMES). ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20), DOSAGE REGIMEN AND ROUTE OF ADMINISTRATION NOT PROVIDED, IN AN UNSPECIFIED LOCATION. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT RECEIVED SECOND INJECTION OF SYNVISC. IT WAS REPORTED THAT AFTER SECOND INJECTION, THE PT WENT TO EMERGENCY DEPARTMENT WITH THE COMPLAINT OF PAIN AND SWELLING. THE ACTION TAKEN WITH SYNVISC WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF PAIN AND SWELLING WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS SEVERE. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE BOTH EVENTS. F/U INFO RECEIVED ON (B)(6) 2013, FROM THE PHYSICIAN REGARDING PT'S MEDICAL HISTORY, LAB DATA, SUSPECT THERAPY DETAILS, LOT NUMBER, CONCOMITANT MEDICATIONS AND EVENT INFO WHICH UPGRADED THE CASE TO SERIOUS. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOARTHRITIS OF LEFT KNEE (GRADE; MODERATE TO SEVERE) WITH JOINT NARROWING, PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC ONE (TWO TIMES) AND SYNVISC, PREVIOUS TREATMENT WITH NONSTEROIDS ANTI-INFLAMMATORY DRUGS AND STEROIDS. ON (B)(6), 2013, THE PT INITIATED TREATMENT WITH SYNVISC, AT A DOSE OF 2 ML IN LEFT KNEE. THE LOT NUMBER FOR SYNVISC WAS PROVIDED. IT WAS REPORTED THAT THE PT DEVELOPED SOME SWELLING IN LEFT KNEE AFTER FIRST INJECTION. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PT RECOVERED FROM SWELLING IN LEFT KNEE. ON (B)(6) 2013, THE PT RECEIVED SECOND INJECTION OF SYNVISC. ON THE SAME DAY, THE PT DEVELOPED PAIN IN LEFT KNEE. ON (B)(6) 2013, TWO DAYS AFTER SECOND INJECTION, THE PT UNDERWENT ARTHROCENTESIS WHICH REQUIRED ASPIRATION OF BLOODY EFFUSION OF LEFT KNEE. ON AN UNSPECIFIED DATE OF 2013, THE PT DEVELOPED SEPTIC REACTION IN LEFT KNEE AND WAS SEEN IN EMERGENCY ROOM ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM THE EVENTS OF PAIN IN LEFT KNEE. THE OUTCOME FOR THE EVENTS OF BLOODY EFFUSION IN LEFT KNEE AND SEPTIC REACTION IN LEFT KNEE WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE IBUPROFEN. THE INTENSITY FOR THE EVENT OF SEPTIC REACTION IN LEFT KNEE WAS SEVERE. THE INTENSITY FOR THE EVENT BLOODY EFFUSION IN LEFT KNEE WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF PAIN IN LEFT KNEE AND SWELLING IN LEFT KNEE AS DEFINITE. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE SYNVISC AND THE EVENTS OF SEPTIC REACTION IN LEFT KNEE AND BLOODY EFFUSION IN LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231786 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other