BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE

    MDR report key: 7171125 · Received January 8, 2018

    Report

    Report Number
    2246315-2017-00440
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 2, 2017
    Report Date
    December 14, 2017
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 14-DEC-2017 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A 45 YEAR OLD FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND AFTER 2 DAYS HAD PAIN IN KNEE/LEFT KNEE PAIN, 01 DAY LATER EXPERIENCED SWELLING IN KNEE, LIMITED RANGE OF MOTION, DIFFICULTY BEARING WEIGHT; AFTER FEW DAYS KNEE ASPIRATED AND AFTER UNKNOWN LATENCY EXPERIENCED ACUTE SEPTIC ARTHRITIS, LEFT KNEE, HAD A FALL, INSTABILITY OF HER KNEE, MEDIAL AND LATERAL MENISCAL TEARS. ALSO, DEVICE MALFUNCTION WAS IDENTIFIED FOR THE REPORTED LOT NUMBER. NO RELEVANT CONCOMITANT MEDICATIONS, PAST DRUGS AND CONCURRENT CONDITION WERE REPORTED. THE PATIENT HAD ADVANCED ARTHRITIS IN 2 PRIOR KNEE PROCEDURES. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC ONE INJECTION, ONCE (BATCH/ LOT NUMBER: 7RSL021, EXPIRATION DATE: 31-MAY-2020; DOSE, INDICATION: NOT REPORTED) FOR OSTEOARTHRITIS, LEFT KNEE (IN LEFT KNEE IN AN OUTPATIENT SETTING). ON (B)(6) - 2017, 01 DAY AFTER INITIATING TREATMENT WITH ALEMTUZUMAB, THE PATIENT EXPERIENCED LEFT KNEE PAIN AND SWELLING; LIMITED RANGE OF MOTION; DIFFICULTY BEARING WEIGHT. ON (B)(6) 2017, AFTER 2 DAYS OF RECEIVING INJECTION, PATIENT CALLED BACK TO THE OFFICE COMPLAINING OF PAIN AND SWELLING IN HER KNEE. PATIENT WAS ADVISED TO GO TO ER (EMERGENCY ROOM) DUE TO CONCERN OF JOINT INFECTION SYMPTOMS. ON (B)(6) 2017, PATIENT CALLED ORTHO FOR FOLLOW UP APPOINTMENT. PATIENT WAS DISCHARGED HOME AND WAS SEEN IN THE OFFICE FOR FOLLOW UP VISIT ON (B)(6) 2017. IT WAS REPORTED THAT SYNVISC ONE WAS DISCONTINUED ON (B)(6) 2017. ON (B)(6) 2017, PATIENT'S KNEE ASPIRATED AND SENT FOR CULTURE. PATIENT WAS SCHEDULED FOR FOLLOW UP ON (B)(6) 2017. ON (B)(6) 2017, THE KNEE WAS DRAINED AND GRAM STAIN WAS DONE IN THE OR (OPERATION ROOM). ON THE SAME DAY, DURING THE VISIT, SYNOVIAL FLUID RESULTS WERE REVIEWED THERE WAS NO EVIDENCE OF INFECTION AND NO CRYSTALS WERE NOTED. CULTURES WERE NEGATIVE. PATIENT WAS SCHEDULED FOR PHYSICAL THERAPY. TREATMENTS INVOLVED WAS USING OXYCODONE AND 800 MG IBUPROFEN. THERE WAS NO FEVER OR REDNESS ASSOCIATED. CALLER DID NOT THINK THE PATIENT ENGAGED IN ACTIVITIES SUCH AS JOGGING OR TENNIS SOON AFTER THE INJECTION SINCE SHE HAD LIMITED RANGE OF MOTION. IT WAS STATED THAT THE PATIENT WAS RECOVERING AS PER THE LAST VISIT AND DID NOT HAVE THE PAIN SCALE THAT WAS ASSOCIATED. IT WAS REPORTED THAT PATIENT HAD MET WITH ORTHOPEDIC SURGEONS IN THE PAST AND WAS TOLD THAT SHE WAS TOO YOUNG TO HAVE A KNEE REPLACEMENT SURGERY. THE PATIENT WAS EXPLAINED THAT SHE HAD ADVANCED ARTHRITIS IN 2 PRIOR KNEE PROCEDURES. THE PATIENT WAS FURTHER EXPLAINED THAT ARRANGEMENTS COULD BE MADE FOR HER TO VISIT WITH A SURGEON TO DISCUSS IF SURGICAL INTERVENTION WAS A VIABLE OPTION. ON UNKNOWN DATE, AFTER UNKNOWN LATENCY, THE PATIENT HAD FALLS FROM INSTABILITY OF HER KNEES. SHE HAD MET WITH SURGEON. PATIENT WOULD FOLLOW-UP IN 3 WEEKS FOR RECHECK. ON AN UNKNOWN DATE, AFTER UNKNOWN, THE PATIENT EXPERIENCED ACUTE SEPTIC ARTHRITIS, LEFT KNEE. ON AN UNKNOWN DATE, AFTER UNKNOWN LATENCY, THE PATIENT EXPERIENCED MEDIAL AND LATERAL MENISCAL TEARS. ON (B)(6) 2017, THE PATIENT CALLED BACK INTO OFFICE. THE PATIENT WAS SEEN IN THE OFFICE EARLIER FOR FOLLOW-UP AND APPARENTLY AT THAT TIME THE GRAMPOSITIVE COCCI ON GRAM STAIN WERE NOT KNOWN AND SHE WENT HOME TO BE CALLED BACK AS THE LABORATORY STUDIES WERE REVIEWED AT 1155 MORNING. PATIENT WAS SCHEDULED FOR POST OP FOLLOW UP ON (B)(6) 2017. CORRECTIVE TREATMENT: NOT REPORTED FOR LIMITED RANGE OF MOTION; OXYCODONE, IBUPROFEN, KNEE DRAINED/ASPIRATED FOR REST EVENTS OUTCOME: NOT RECOVERED/NOT RESOLVED FOR PAIN IN KNEE/LEFT KNEE PAIN, KNEE ASPIRATED; RECOVERING FOR ALL EVENTS A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: 51304 AN INVESTIGATION WAS INITIATED AS A RESULT OF AN UNEXPECTED INCREASE IN THE NUMBER OF LABELLED ADVERSE EVENTS RECEIVED FROM THE US MARKET FOR SYNVISC ONE, LOT 7RSL021. THE PRODUCT MET ALL RELEASE TESTING AT TIME OF MANUFACTURE IN JUNE 2017. RETAIN SAMPLES WERE RETESTED DUE TO THE UNEXPECTED INCREASE IN ADVERSE EVENTS. HIGHER THAN EXPECTED ENDOTOXIN RESULTS WERE OBTAINED. IN ADDITION, THE PRESENCE OF MICROBIAL CONTAMINATION WAS ALSO CONFIRMED. THE CAUSE OF THESE EVENTS WAS UNDER INVESTIGATION. ONCE THIS INVESTIGATION IS COMPLETED, CORRECTIVE AND PREVENTIVE ACTIONS WOULD BE IMPLEMENTED. SERIOUSNESS CRITERION: REQUIRED INTERVENTION FOR DEVICE MALFUNCTION, PAIN IN KNEE/LEFT KNEE PAIN, SWELLING IN KNEE, KNEE ASPIRATED; IMPORTANT MEDICAL EVENT FOR ACUTE SEPTIC ARTHRITIS, LEFT KNEE ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. CLINICAL COURSE UPDATED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 FROM A HEALTHCARE PROFESSIONAL. ADDITIONAL EVENTS OF ACUTE SEPTIC ARTHRITIS, LEFT KNEE, FALL, INSTABILITY OF HER KNEE, MEDIAL AND LATERAL MENISCAL TEARS, DIFFICULTY BEARING WEIGHT, DEVICE MALFUNCTION WERE ADDED WITH DETAILS. DOSING DETAILS OF THE SUSPECT PRODUCT WAS UPDATED (LOT NUMBER WAS UPDATED; INDICATION ADDED). EVENT TERM OF PAIN IN KNEE WAS UPDATED TO PAIN IN KNEE/LEFT KNEE PAIN AND ITS OUTCOME WAS UPDATED TO NOT RECOVERED AND ITS ONSET DATE WAS ALSO UPDATED. OUTCOME OF KNEE ASPIRATED WAS UPDATED TO NOT RECOVERED. ONSET DATE OF LIMITED RANGE OF MOTION WAS UPDATED AND ITS OUTCOME WAS UPDATED TO NOT RECOVERED. ONSET DATE OF SWELLING IN HER KNEE WAS UPDATED AND ITS OUTCOME WAS UPDATED TO NOT RECOVERED. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2018: THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION FROM THE RECALLED LOT AND LATER EXPERINCED TO HAVE SEPTIC ARTHRITIS, LEFT KNEE PAIN, LEFT KNEE SWELLING, EFFUSION (L) KNEE, JOINT RANGE OF MOTION DECREASED, WEIGHT BEARING DIFFICULTY, FALL, JOINT IN STABILITY AND MENISCUS TEAR OF KNEE. TEMPORAL RELATIONSHIP CAN BE ESTABLISHED BETWEEN THE EVENTS AND THE SUSPECT PRODUCT BASED ON THE AVAILABLE INFORMATION (EXCEPT FOR THE EVENTS OF SEPTIC ARTHRITIS, FALL, JOINT INSTABILITY, MENISCUS TEAR OF KNEE). ADDITIONALLY, AS THE CONCERNED LOT NUMBER HAS BEEN IDENTIFIED TO HAVE MALFUNCTION BY THE COMPANY. THEREFORE, PHARMACOLOGICAL PLAUSIBILITY OF THE EVENT TO THE PRODUCT CANNOT BE EXCLUDED (EXCEPT FOR THE EVENTS OF SEPTIC ARTHRITIS, FALL, JOINT INSTABILITY, MENISCUS TEAR OF KNEE).

    Description of Event or Problem · 0

    THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 14-DEC-2017 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND AFTER 2 DAYS HAD PAIN IN KNEE, SWELLING IN KNEE; AFTER FEW DAYS KNEE ASPIRATED AND LIMITED RANGE OF MOTION NO RELEVANT CONCOMITANT MEDICATIONS, PAST DRUGS, MEDICAL HISTORY, AND CONCURRENT CONDITION WERE REPORTED. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC ONE INJECTION, ONCE (BATCH/ LOT NUMBER, DOSE, INDICATION AND EXPIRATION DATE: NOT REPORTED) IN LEFT KNEE IN AN OUTPATIENT SETTING. ON (B)(6) 2017, AFTER 2 DAYS OF RECEIVING INJECTION, PATIENT CALLED BACK TO THE OFFICE COMPLAINING OF PAIN AND SWELLING IN HER KNEE. PATIENT WAS ADVISED TO GO TO ER (EMERGENCY ROOM). PATIENT WAS DISCHARGED HOME AND WAS SEEN IN THE OFFICE FOR FOLLOW UP VISIT ON (B)(6) 2017. ON AN UNKNOWN DATE IN (B)(6) 2017, AFTER FEW DAYS OF RECEIVING INJECTION, PATIENT KNEE WAS ASPIRATED AND CULTURE WAS DONE. ON (B)(6) 2017, THE KNEE WAS DRAINED AND GRAM STAIN WAS DONE IN THE OR (OPERATION ROOM). TREATMENTS INVOLVED WAS USING OXYCODONE AND 800 MG IBUPROFEN. THERE WAS NO FEVER OR REDNESS ASSOCIATED. CALLER DID NOT THINK THE PATIENT ENGAGED IN ACTIVITIES SUCH AS JOGGING OR TENNIS SOON AFTER THE INJECTION SINCE SHE HAD LIMITED RANGE OF MOTION (ONSET DATE: (B)(6) 2017; LATENCY: FEW DAYS).IT WAS STATED THAT THE PATIENT WAS RECOVERING AS PER THE LAST VISIT AND DID NOT HAVE THE PAIN SCALE THAT WAS ASSOCIATED. CORRECTIVE TREATMENT: NOT REPORTED FOR LIMITED RANGE OF MOTION; OXYCODONE, IBUPROFEN, KNEE DRAINED/ASPIRATED FOR REST EVENTS OUTCOME: RECOVERING FOR ALL EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: 51304 THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORED ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS AND ASSESSED POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERION: HOSPITALIZATION FOR BOTH EVENTS ADDITIONAL INFORMATION WAS RECEIVED ON 12-JAN-2018. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. CLINICAL COURSE UPDATED. TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2017 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND AFTER 2 DAYS HAD PAIN IN KNEE, SWELLING IN KNEE; AFTER FEW DAYS KNEE ASPIRATED AND LIMITED RANGE OF MOTION NO RELEVANT CONCOMITANT MEDICATIONS, PAST DRUGS, MEDICAL HISTORY, AND CONCURRENT CONDITION WERE REPORTED. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC ONE INJECTION, ONCE (BATCH/ LOT NUMBER, DOSE, INDICATION AND EXPIRATION DATE: NOT REPORTED) IN LEFT KNEE IN AN OUTPATIENT SETTING. ON (B)(6) 2017, AFTER 2 DAYS OF RECEIVING INJECTION, PATIENT CALLED BACK TO THE OFFICE COMPLAINING OF PAIN AND SWELLING IN HER KNEE. PATIENT WAS ADVISED TO GO TO ER (EMERGENCY ROOM). PATIENT WAS DISCHARGED HOME AND WAS SEEN IN THE OFFICE FOR FOLLOW UP VISIT ON (B)(6) 2017. ON AN UNKNOWN DATE IN (B)(6) 2017, AFTER FEW DAYS OF RECEIVING INJECTION, PATIENT KNEE WAS ASPIRATED AND CULTURE WAS DONE. ON (B)(6) 2017, THE KNEE WAS DRAINED AND GRAM STAIN WAS DONE IN THE OR (OPERATION ROOM). TREATMENTS INVOLVED WAS USING OXYCODONE AND 800 MG IBUPROFEN. THERE WAS NO FEVER OR REDNESS ASSOCIATED. CALLER DID NOT THINK THE PATIENT ENGAGED IN ACTIVITIES SUCH AS JOGGING OR TENNIS SOON AFTER THE INJECTION SINCE SHE HAD LIMITED RANGE OF MOTION (ONSET DATE: (B)(6) 2017; LATENCY: FEW DAYS).IT WAS STATED THAT THE PATIENT WAS RECOVERING AS PER THE LAST VISIT AND DID NOT HAVE THE PAIN SCALE THAT WAS ASSOCIATED. CORRECTIVE TREATMENT: NOT REPORTED FOR LIMITED RANGE OF MOTION; OXYCODONE, IBUPROFEN, KNEE DRAINED/ASPIRATED FOR REST EVENTS OUTCOME: RECOVERING FOR ALL EVENTS A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: HOSPITALIZATION FOR BOTH EVENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16147 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) 7RSL021

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention