BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2358016 · Received November 29, 2011

    Report

    Report Number
    2246315-2011-00301
    Event Type
    Other
    Date Received
    November 29, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 20, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 25-JAN-2012. THE LOT NUMBER OF SYNVISC WAS U1116. EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED AND BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. ON A PERIODIC BASIS, DATA IS 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 31-JAN-2012, IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER UL 116, EXPIRY DATE 2014-07 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER UL 116, EXPIRY DATE 2014-07 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 22-NOV-2011 IN THE FORM OF INVESTIGATION 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 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 CORRECTIVE ACTION IS REQUIRED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT 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 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 CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A (B)(6) YEAR OLD MALE PATIENT, INITIALS, (B)(6) WITH ARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F 20) AT 6ML, ONCE. THE SYNVISC-ONE LOT NUMBER WAS NOT PROVIDED. IT WAS REPORTED THAT HE FELT FINE AFTER THE INJECTION BUT ON THE SAME NIGHT HE BEGAN EXPERIENCING SEVERE PAIN. THE NEXT DAY, THE PAIN WAS REPORTED TO BE VERY SEVERE AND THAT THE PATIENT COULD BARELY WALK. HE WENT TO URGENT CARE AND WAS GIVEN PAIN KILLERS. ON AN UNSPECIFIED DATE, TWO DAYS AFTER RECEIVING THE SYNVISC-ONE INJECTION, THE PATIENT STILL FELT SEVERE PAIN AND COULD BARELY WALK. HE COULD NOT PUT SOCKS AND SHOES WITHOUT ASSISTANCE. NO ACTION WAS TAKEN WITH SYNVISC-ONE. THE OUTCOME OF THE EVENTS OF SEVERE PAIN AND GAIT DISTURBANCE WAS NOT YET RECOVERED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF GAIT DISTURBANCE WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 22-NOV-2011. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS TREATMENT WITH SYNVISC-ONE IN BOTH KNEES, SIX MONTHS PRIOR TO THIS REPORT. ON (B)(6) 2011, THE PATIENT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F 20) IN THE LEFT KNEE. ON THE SAME DAY, AFTER RECEIVING THE SYNVISC-ONE INJECTION, THE PATIENT EXPERIENCED SEVERE PAIN. ON (B)(6) 2011, THE PATIENT HAD BEEN SEEN IN THE URGENT CARE WHERE HIS X-RAYS WERE TAKEN AND HE WAS PRESCRIBED PAIN PILLS. ON (B)(6) 2011, HE WAS SEEN BY HIS HCP AND 80CC OF FLUID WAS REMOVED FROM THE KNEE WHICH WAS INDICATED AS PSEUDO GOUT. IT WAS REPORTED THAT THE KNEE CONTINUED TO SWELL AND THE PATIENT WAS STILL IN PAIN. HE WAS PLACED ON NAPROXEN (NAPROXYN). THE OUTCOME OF THE EVENTS OF KNEE SWELLING AND KNEE EFFUSION WAS NOT YET RECOVERED AND OF PSEUDO GOUT WAS NOT PROVIDED. THE INTENSITY FOR KNEE SWELLING, KNEE EFFUSION AND PSEUDO GOUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554583 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention GLUCOSAMINE.