BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3396914 · Received September 9, 2013

    Report

    Report Number
    2246315-2013-00442
    Event Type
    Other
    Date Received
    September 9, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 19, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # R1219 AND LOT # R12021, WITH EXPIRATION DATES ON APRIL 2015 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT BATCH RECORD REVIEW AND LOT FREQUENCY ANALYSIS FOR LOT # R1219 AND LOT # R12021, NO CAPA IS REQUIRED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    BOTH KNEES FLARED [ARTHROPATHY], KNEE EFFUSION [JOINT EFFUSION], ALLERGIC REACTION [HYPERSENSITIVITY]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A NON HEALTH PROFESSIONAL REGARDING A MALE PT (AGE NOT PROVIDED), INITIALS UNKNOWN. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20) INJECTION, ONCE, INTO BOTH KNEES (ROUTE AND DOSE NOT PROVIDED). THE LOT NUMBER FOR SYNVISC ONE WAS NOT PROVIDED. ON UNSPECIFIED DATES, THE PT'S BOTH KNEES WERE FLARED AND THE KNEES WERE DRAINED (KNEE EFFUSION). THE OUTCOME FOR THE EVENTS OF BOTH KNEES FLARED AND KNEE EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATION WAS NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC ONE AND BOTH THE EVENTS WAS NOT PROVIDED. FOLLOW-UP INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN PROVIDING PT DETAILS, PAST MEDICAL HISTORY, SYNVISC ONE LOT NUMBER, EVENTS INFO, CONCOMITANT AND TREATMENT MEDICATION (CORTICOSTEROIDS) WHICH UPGRADED THE CASE TO SERIOUS. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOARTHRITIS OF BOTH KNEES (X-RAY GRADE III, MODERATE TO SEVERE, SINCE MORE THAN TEN YEARS WITH JOINT NARROWING AND PRIOR EFFUSION); SPLENECTOMY; PREVIOUS TREATMENT WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, STEROIDS AND PREVIOUS USE OF SYNVISC ONE; MILD ALLERGIC REACTION AND NON-INSULIN DEPENDENT DIABETES MELLITUS. ON (B)(6) 2013, THE PT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE, AT A DOSE OF 6ML. ON THE SAME DAY, BOTH THE KNEES WERE FLARED AND THE PT DEVELOPED KNEE EFFUSION. ON (B)(6) 2013, THE ARTHROCENTESIS WAS PERFORMED AND 30 ML OF YELLOW CLOUDY FLUID WAS ASPIRATED FROM RIGHT KNEE AND 37 ML OF YELLOW CLOUDY FLUID WAS ASPIRATED FROM LEFT KNEE. ON THE SAME DAY, THE PT RECEIVED CORTICOSTEROID INJECTION WITH ULTRASOUND GUIDE AND RECOVERED FROM BOTH THE EVENTS. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PT DEVELOPED ALLERGIC REACTION. THE OUTCOME FOR THE EVENT OF ALLERGIC REACTION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS INCLUDED AMAREL (GLIMEPIRIDE). THE INTENSITY FOR THE EVENTS OF BOTH KNEES FLARED AND ALLERGIC REACTION WAS SEVERE AND INTENSITY FOR THE EVENT OF KNEE EFFUSION WAS MODERATE. THE REPORTING PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP BETWEEN SYNVISC ONE AND THE EVENTS OF BOTH THE KNEES FLARED AND KNEE EFFUSION AS DEFINITE. THE REPORTING PHYSICIAN DID NOT PROVIDE CAUSAL RELATIONSHIP BETWEEN SYNVISC ONE AND THE EVENT OF ALLERGIC REACTION. IN THE PHYSICIAN'S OPINION, THE PT HAD A MILD ALLERGIC REACTION TO PREVIOUS SYNVISC TREATMENT AND A SEVERE ALLERGIC REACTION TO THE NEXT SYNVISC ONE TREATMENT ON ((B)(6) 2013), THEREFORE, THE PT COULD NOT GET ANY MORE AVIAN RELATED VISCOSUPPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447197 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK R1219 / R12021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention