BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3240340 · Received July 18, 2013

    Report

    Report Number
    2246315-2013-00401
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    July 9, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS RECEIVED IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY ON (B)(4) 2013. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #Q1224, WITH EXPIRATION DATE (03/2015) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. EVAL SUMMARY: THE PRODUCTION AND QC DOCUMENTATION FOR LOT #Q1224, WITH EXPIRATION DATE (03/2015) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    INFLAMMATORY REACTION [INFLAMMATION]. COULD NOT FOLD HIS KNEES [JOINT RANGE OF MOTION DECREASED]. PUNCTION OF THE KNEES [JOINT EFFUSION]. FEVER [PYREXIA]. PAIN IN BOTH KNEE JOINTS/FEELS THE PAIN UNTIL THE FEET/ ARTHROSIS PAIN HAS WORSENED [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A MALE PT (AGE NOT PROVIDED), INITIALS (B)(6), WITH ARTHROSIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN GF-20) INJECTION, ONCE, IN BOTH KNEES (DOES AND ROUTE NOT PROVIDED). IT WAS REPORTED THAT THE PT HAD THE INJECTIONS ON THE SAME DAY OF AN OPERATION AT THE SHOULDER. ON UNSPECIFIED DATES IN (B)(6) 2013 (ONE WEEK LATER,) THE PT HAD A FEVER (38 TO 39 DEGREES CELSIUS) AND COULD NOT FOLD HIS KNEES ANYMORE (BOTH THE EVENTS WERE ASSESSED AS SERIOUS DUE TO HOSPITALIZATION). THE COMPANY ASSESSED THE EVENT OF FEVER AS MEDICALLY SIGNIFICANT. ON (B)(6) 2013. THE PT WAS HOSPITALIZED AND PUNCTURE OF KNEES (JOINT EFFUSION OF BOTH KNEES) WAS PERFORMED BECAUSE THERE WAS AN INFLAMMATORY REACTION (SYNOVIAL FLUID ANALYSIS WAS NEGATIVE; NO GERMS WERE FOUND). ON AN UNSPECIFIED DATE IN (B)(6) 2013 (ONE WEEK LATER), THE PT HAD PAIN IN BOTH KNEE JOINTS AND THE PT FELT PAIN UNTIL THE FEET. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PT RECOVERED FROM THE EVENT OF THE INFLAMMATORY REACTION. IT WAS REPORTED THAT THE ARTHROSIS PAIN HAD WORSENED (PAIN IN BOTH KNEES NOT YET RECOVERED. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PT WAS DISCHARGED AFTER ONE WEEK OF HOSPITALIZATION. THE OUTCOME FOR THE EVENTS OF FEVER, JOINT EFFUSION OF BOTH KNEES AND COULD NOT FOLD HIS KNEES WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE NSAIDS (UNSPECIFIED). THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP OF SYNVISC ONE WITH ALL THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334326 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK Q1224

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O