BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1993379 · Received February 8, 2011

    Report

    Report Number
    2246315-2011-00019
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 18, 2011
    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

    EVAL 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 CONFORMANCE TO SPECS PRIOR TO RELEASE. ANY OUT OF SPEC RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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

    PAIN IN RIGHT KNEE [ARTHRALGIA]. JOINT FLUID RETENTION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011, FROM A HEALTH CARE PROVIDER (HCP) REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS UNK. THE PT EXPERIENCED PAIN IN THE RIGHT KNEE AND JOINT FLUID RETENTION AFTER RECEIVING SYNVISC. ON UNSPECIFIED DATES, THE PT RECEIVED AN UNSPECIFIED NUMBER OF SYNVISC INJECTIONS INTO THE RIGHT KNEE. ON (B)(6) 2011, THE PT EXPERIENCED PAIN IN THE RIGHT KNEE AND JOINT FLUID RETENTION. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM BOTH EVENTS. NO ADD'L INFO WAS PROVIDED. ADD'L INFO WAS RECEIVED ON (B)(4) 2011 IN THE FORM OF QA RESULTS. 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 CONFORMANCE TO SPECS PRIOR TO RELEASE. ANY OUT OF SPEC RESULT IS IDENTIFIED AND MITIGATED THROUGH NCR PROCESS. 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. ADD'L INFO WAS RECEIVED ON (B)(6) 2011, FROM THE HCP. THE HCP REPORTED THE PT HAD A HISTORY OF GONARTHROSIS AND GASTRITIS. ON (B)(6) 2011, THE PT HAD ONE 2 ML SYNVISC INJECTION. PAIN IN THE RIGHT KNEE AND JOINT FLUID RETENTION DEVELOPED. THE PT STOPPED SYNVISC THERAPY. THE PT'S CONCOMITANT THERAPY INCLUDED: LOXOPROFEN SODIUM ((B)(6) 2008 - CONTINUING, GONARTHROSIS), KETOPROFEN ((B)(6) 2008 - CONTINUING, GONARTHROSIS), INDOMETHACIN ((B)(6) 2008 - CONTINUING, GONARTHROSIS), REBAMIPIDE ((B)(6) 2011 - CONTINUING, GASTRITIS), AND TRIAMCINOLONE ACETONIDE ((B)(6) 2011 - CONTINUING, 10 ML, PAIN). THE REPORTING PHYSICIAN ASSESSED THE EVENTS AS DEFINITELY RELATED TO SYNVISC. HE DID NOT PROVIDE SEVERITY. THE PT'S CORRECTIVE TREATMENT INCLUDED DICLOFENAC SODIUM, WHICH STARTED ON (B)(6) 2011 FOR PAIN AND WAS CONTINUING AT THE TIME OF THIS REPORT. ON (B)(6) 2011, THE PT'S EVENTS RESOLVED. ADD'L INFO WAS RECEIVED ON (B)(6) 2011 FROM THE HCP. THE PT HAD A HISTORY OF GONARTHROSIS AND CERVICAL DISC LESION. THE HCP REPORTED ON (B)(6) 2011, AROUND 15:00, THE PT HAD TREATMENT FOR GONARTHROSIS IN BOTH KNEES. FIRSTLY, SHE HAD 37 ML OF RIGHT KNEE JOINT FLUID ASPIRED BY PUNCTURE AND THEN THE INTRAARTICULAR SYNVISC INJECTION 2 ML. SHE ALSO HAD SYNVISC INJECTION 2 ML INTO THE LEFT KNEE INTRAARTICULARLY. IMMEDIATELY AFTER THE INJECTION, THE PT'S PAIN IN THE RIGHT KNEE WAS AGGRAVATED AND THE PT'S FLUID RETENTION INCREASED IN THE RIGHT KNEE. ON (B)(6) 2011, AROUND 15:00, SHE HAD PUNCTURE ASPIRATION OF JOINT FLUID 50ML AT RIGHT KNEE. THE FLUID WAS LIGHT YELLOW AND TRANSPARENT. SHE HAD INTRAARTICULAR INJECTIONS (TRIAMCINOLONE ACETONIDE, 20 MG AND 1% LIDOCAINE) TO THE RIGHT KNEE. SHE HAD THE SECOND INTRAARTICULAR SYNVISC INJECTION 2 ML INTO THE LEFT KNEE. ADDITIONALLY, DICLOFENAC SODIUM (3 TABLETS) AND REBAMIPIDE (3 TABLETS) WERE PRESCRIBED TO TAKE AFTER EVERY MEAL FOR SEVEN DAYS. THEREAFTER, THE PAIN IN RIGHT KNEE ALLEVIATED AND THE SWELLING OF RIGHT KNEE DISAPPEARED. THE REPORTING PHYSICIAN ASSESSED THE EVENTS AS SERIOUS AND PROBABLY RELATED TO SYNVISC. HE DID NOT PROVIDE SEVERITY ASSESSMENT. CONCOMITANT THERAPY INCLUDED: LOXOPROFEN SODIUM ((B)(6) 2006-CONTINUING, GONARTHROSIS IN KNEES), KETOPROFEN ((B)(6) 2006 - CONTINUING, GONARTHROSIS), INDOMETHACIN ((B)(6) 2008 - CONTINUING, GONARTHROSIS), REBAMIPIDE ((B)(6) 2008 - ONGOING, GONARTHROSIS IN KNEES), TRIAMCINOLONE ACETONIDE ((B)(6) 2006 - CONTINUING GONARTHROSIS IN KNEES), SODIUM HYALURONATE ((B)(6) 2006 - CONTINUING, GONARTHROSIS IN KNEES), ZALTOPROFEN ((B)(6) 2007, GONARTHROSIS IN KNEES), AND LIDOCAINE ((B)(6) 2007 - CONTINUING). THE PT'S CORRECTIVE TREATMENT INCLUDED: TRIAMCINOLONE ACETONIDE ((B)(6) 2011, 20 ML), LIDOCAINE ((B)(6) 2011), REBAMIPIDE ((B)(6) 2011 - CONTINUING), AND DICLOFENAC SODIUM ((B)(6) 2011 - CONTINUING). THE PT DID NOT HAVE ANY ALLERGIES. THE LOT NUMBER WAS UNK. ON (B)(6) 2011, SYNVISC WAS PERMANENTLY STOPPED FOR THE PT'S RIGHT KNEE. THE HCP REPORTED BOTH OF THE PT'S ADVERSE EVENTS RESOLVED ON (B)(6) 2011. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention REBAMIPIDE (B)(6) 2007 TO ONGOING| LOXOPROFEN SODIUM UNK, (B)(6) 2006 TO ONGOING| KETOPROFEN UNK, (B)(6) 2006 TO ONGOING| TRIAMCINOLONE ACETONIDE UNK, (B)(6) 2011 TO UNK| INDOMETACIN UNK, (B)(6) 2008 TO ONGOING