BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3150118 · Received June 3, 2013

    Report

    Report Number
    2246315-2013-00342
    Event Type
    Other
    Date Received
    June 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) RESULT WAS REC'D ON (B)(6) 2013 IN THE FORM OF INVESTIGATION SUMMARY. 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 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PAIN OF HIS RIGHT KNEE [ARTHRALGIA], SWELLING OF HIS RIGHT KNEE [JOINT SWELLING], WATER ON THE KNEE [JOINT EFFUSION], DIFFICULTY IN SLEEPING [INSOMNIA], DIFFICULTY IN WALKING [GAIT][DISTURBANCE], NO BENEFICIAL EFFECTS OF SYNVISC [THERAPEUTIC RESPONSE DECREASED]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2013 FROM A (B)(6) MALE PT; INITIALS UNK, WITH OSTEOARTHRITIS OF RIGHT KNEE. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PT REC'D TREATMENT WITH SINGLE DOSE OF SYNVISC (HYLAN G-F 20) INJECTION, INTO THE RIGHT KNEE (ROUTE OF ADMINISTRATION AND DOSAGE REGIMENT NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. AT THE SAME VISIT TO HIS DOCTOR, THE PT ALSO REC'D CORTISONE (UNSPECIFIED) INJECTION TO THE RIGHT KNEE. THE SAME DAY, THE PT EXPERIENCED SWELLING AND PAIN IN HIS RIGHT KNEE ACCOMPANIED BY DIFFICULTY IN WALKING AND DIFFICULTY SLEEPING. ON AN UNSPECIFIED DATE IN 2013, THE PT DEVELOPED EFFUSION OF RIGHT KNEE ("WATER IN THE KNEE"). IT WAS REPORTED THAT HE CONTACTED HIS PHYSICIAN ABOUT HIS SYMPTOMS AND HE WAS ADVISED TO WAIT LONGER. THE PT REPORTED THAT HE DID NOT EXPERIENCE ANY BENEFICIAL EFFECTS OF SYNVISC (SUBTHERAPEUTIC RESPONSE). ON (B)(6) 2013, ARTHROCENTESIS WAS PERFORMED AND 85 CC OF "WATER" WAS REMOVED FROM HIS RIGHT KNEE. ON THE SAME DAY, THE PT REC'D ANOTHER CORTISONE (UNSPECIFIED) INJECTION AS A TREATMENT FOR THE EVENTS OF SWELLING AND PAIN OF HIS RIGHT KNEE AND "WATER ON THE KNEE". ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PT RECOVERED FROM THE EVENT OF "WATER ON THE KNEE". ON (B)(6) 2013, THE PT RECOVERED FROM THE EVENTS OF SWELLING OF HIS RIGHT KNEE, PAIN OF HIS RIGHT KNEE, DIFFICULTY IN WALKING AND DIFFICULTY IN SLEEPING. AT THE TIME OF THE REPORT, THE PT WAS AT THE SAME LEVEL AS BEFORE THE ADMINISTRATION OF SYNVISC. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF "NO BENEFICIAL EFFECTS OF SYNVISC" WAS NOT PROVIDED. THE PT WAS RECEIVING CONCOMITANT MEDICATIONS (UNSPECIFIED). THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE CASUAL RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242434 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CORTICOSTEROID NOS (CORTICOSTEROID NOS) INJECTION