BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2992723 · Received March 1, 2013

    Report

    Report Number
    2246315-2013-00047
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    July 4, 2012
    Report Date
    October 17, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2012 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY. 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    ARTHRITIS. PAIN IN RIGHT KNEE [ARTHRALGIA]. SWELLING IN RIGHT KNEE [JOINT SWELLING]. RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012 FROM A PHYSICIAN REGARDING A PATIENT (DEMOGRAPHICS NOT PROVIDED), (B)(6). PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION (ROUTE AND DOSAGE REGIMEN NOT PROVIDED), INTO AN UNSPECIFIED LOCATION. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN ADVERSE REACTION. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY OF THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE ANY CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2013 FROM THE PHYSICIAN REGARDING PATIENT INFORMATION, RELEVANT HISTORY, PRODUCT INFORMATION, EVENT INFORMATION, CLINICAL COURSE AND TREATMENT WHICH UPGRADED THE CASE TO SERIOUS. THE PATIENT WAS IDENTIFIED AS A (B)(6) FEMALE. THE PATIENT'S CONCOMITANT DISEASES INCLUDED OSTEOPOROSIS, LUMBAR SPINAL CANAL STENOSIS AND L4 SPONDYLOLITHESIS. THE PATIENT'S MEDICAL HISTORY INCLUDED GONARTHROSIS OF BOTH KNEES WITH KELLGREN AND LAWRENCE GRADE 3 (DEVELOPED FOUR TO FIVE YEARS BACK) AND WAS DIAGNOSED ON (B)(6) 2012. ON THE SAME DAY, THE PATIENT INITIATED TREATMENT WITH SYNVISC AT A DOSE OF 2 ML INTO BOTH KNEES. ON (B)(6) 2012, THE PATIENT RECEIVED SECOND INJECTION OF SYNVISC AT A DOSE OF 2 ML INTO BOTH KNEES. ON (B)(6) 2012, THE PATIENT RECEIVED THIRD INJECTION OF SYNVISC AT A DOSE OF 2 ML EXTERNAL SUPRAPATELLAR OF BOTH KNEES. IT WAS REPORTED THAT THERE WAS NO FLUID RETENTION PRIOR TO ALL THREE INJECTIONS. ALSO, THE PATIENT HAD INTRA-ARTICULAR INFLAMMATORY SYMPTOM (MODERATE) IN RIGHT KNEE PRIOR TO THIRD INJECTION. AFTER THIRD INJECTION, THE PATIENT DEVELOPED SWELLING AND PAIN IN THE RIGHT KNEE AFTER SHE WENT HOME AND WERE WORSENING. THE PATIENT WAS DIAGNOSED WITH ARTHRITIS ON THE SAME DAY. ON (B)(6) 2012, YELLOW, OPACIFIED, TURBID JOINT FLUID WAS ASPIRATED. BOTH CULTURE TEST AND CRYSTAL TEST WERE FOUND TO BE NEGATIVE. ON THE SAME DAY JOINT LAVAGE WITH XYLOCAINE (LIDOCAINE) WAS PERFORMED. ON UNSPECIFIED DATES, ARTHROCENTESIS WERE PREFORMED TWO MORE TIMES. ON AN UNSPECIFIED DATE (ABOUT THREE WEEKS AFTER THE EVENT ONSET) THE EVENT OF SWELLING WAS RECOVERED. ON (B)(6) 2012, THE EVENT OF ARTHRITIS WAS RECOVERED. THE OUTCOME FOR THE EVENTS OF PAIN IN RIGHT KNEE AND RIGHT KNEE EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED PRORENAL (LIMAPROST). THE INTENSITY OF THE EVENT OF ARTHRITIS WAS MODERATE. THE INTENSITY FOR THE EVENTS OF PAIN IN RIGHT KNEE, SWELLING IN RIGHT KNEE AND RIGHT KNEE EFFUSION WAS NOT PROVIDED. THE REPORTING PHYSICIAN PROVIDED THE RELATIONSHIP BETWEEN SYNVISC AND EVENT OF ARTHRITIS AS POSSIBLE. THE REPORTING PHYSICIAN DID NOT PROVIDE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF PAIN IN RIGHT KNEE, SWELLING IN RIGHT KNEE AND RIGHT KNEE EFFUSION. IT WAS REPORTED THAT ACUTE ARTHRITIS WAS SECONDARY TO THREE CONSECUTIVE INJECTIONS OF SYNVISC AND THERE WERE NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89839 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention