BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3338757 · Received September 5, 2013

    Report

    Report Number
    2246315-2013-00439
    Event Type
    Other
    Date Received
    September 5, 2013
    Date of Event
    July 27, 2013
    Report Date
    August 27, 2013
    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

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON THE LACK OF INFO PROVIDED, NO CAPA IS REQUIRED. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPEC CONFORMANCE 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 SAFETY. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON THE LACK OF INFO PROVIDED, NO CAPA IS REQUIRED. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPEC CONFORMANCE 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 SAFETY. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    ARTHRITIS [ARTHRITIS]. KNEE FEELING HOT [JOINT WARMTH]. KNEE SWELLING [JOINT SWELLING]. KNEE PAIN [ARTHRALGIA]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS (B)(6), WITH GONARTHROSIS OF BOTH KNEES. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERLIPIDAEMIA, GASTRITIS AND DIZZINESS. ON (B)(6) 2013, THE PT INITIATED TREATMENT WITH FIRST COURSE OF SYNVISC (HYLAN GF-20) INJECTION AT A DOSE OF 02 ML IN BOTH KNEES (ROUTE OF ADMINISTRATION AND FREQUENCY NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2013, THE PT RECEIVED THE SECOND INJECTION OF THE FIRST COURSE OF SYNVISC IN BOTH KNEES. THE SAME DAY (FOUR OR FIVE HOURS LATER AFTER THE SYNVISC INJECTION), THE PT DEVELOPED ARTHRITIS WITH HOT FEELING, SWELLING AND PAIN IN KNEE. THE SAME DAY, TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. ON (B)(6) 2013, 120 CC OF CLOUDY JOINT FLUID WAS ASPIRATED BY ARTHROCENTESIS FROM AN UNSPECIFIED KNEE (KNEE EFFUSION) AND THE PT RECEIVED INTRA-ARTICULAR STEROID INJECTION FOR THE EVENTS AND RECOVERED FROM THE EVENT OF ARTHRITIS. THE OUTCOME FOR THE EVENTS OF KNEE FEELING HOT, KNEE SWELLING, KNEE PAIN AND KNEE EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS INCLUDED SELBEX (TEPRENONE), MEDEPOLIN (ALPRAZOLAM), EPADEL (ETHYL ICOSAPENTATE) AND MUCOSTA (REBAMIPIDE). THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP OF SYNVISC WITH THE EVENT OF ARTHRITIS AS DEFINITE AND DID NOT PROVIDE THE CAUSAL RELATIONSHIP WITH THE EVENTS OF KNEE FEELING HOT, KNEE SWELLING, KNEE PAIN AND KNEE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442436 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S