BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3133868 · Received May 24, 2013

    Report

    Report Number
    2246315-2013-00334
    Event Type
    Other
    Date Received
    May 24, 2013
    Report Date
    April 8, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT. EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    FLUID RETENTION IN LEFT KNEE [JOINT EFFUSION]. RHEUMATOID FACTOR POSITIVE [RHEUMATOID FACTOR POSITIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON APRIL 8, 2013 FROM A PHYSICIAN REGARDING A 72 YEAR OLD FEMALE PATIENT, INITIALS (B)(6), WITH GONARTHROSIS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT'S JOINT FLUID WAS REMOVED. ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION (FIRST INJECTION OF FIRST COURSE) AT A DOSE OF 2 ML INTO AN UNSPECIFIED LOCATION. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, AFTER RECEIVING THE THIRD INJECTION OF THE FIRST COURSE THE PATIENT HAD FLUID RETENTION. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME OF THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS REPORTED INCLUDE LOXOPROFEN AND PREDNISOLONE. THE INTENSITY OF THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT. FOLLOW-UP INFORMATION WAS RECEIVED ON APRIL 30, 2013 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW WAS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAD NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. FOLLOW-UP INFORMATION WAS RECEIVED ON MAY 15, 2013 FROM THE PHYSICIAN REGARDING EVENTS INFORMATION AND TREATMENT MEDICATION WHICH UPGRADED THE CASE TO SERIOUS. THE EVENT OF FLUID RETENTION WAS UPDATED TO FLUID RETENTION OF LEFT KNEE. ON AN UNKNOWN DATE, TEST FOR RHEUMATOID FACTOR WAS POSITIVE. CRYSTAL-INDUCED FACTOR WAS POSSIBLE AND RHEUMATISM (RHEUMATOID FACTOR POSITIVE) COULD NOT BE RULED OUT. ON (B)(6) 2013, THE PATIENT RECEIVED JOINT INJECTION WITH STEROID FOR THE EVENT OF FLUID RETENTION IN THE LEFT KNEE. THE PATIENT HAD NOT YET RECOVERED FROM THE EVENT OF FLUID RETENTION OF LEFT KNEE AND THE OUTCOME OF THE EVENT OF RHEUMATOID FACTOR POSITIVE WAS NOT PROVIDED. THE INTENSITY OF THE EVENT OF RHEUMATOID FACTOR WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF FLUID RETENTION AS POSSIBLE AND DID NOT PROVIDE FOR THE EVENT OF RHEUMATOID FACTOR POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230558 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R