BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 3402954 · Received October 7, 2013

    Report

    Report Number
    2246315-2013-00447
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 24, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. THE PRODUCT AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER N12015, WITH EXPIRATION DATE (11-2004) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. PHARMACOVIGILANCE COMMENT: MFR'S COMMENT THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT. SANOFI COMPANY COMMENT DATED 10/4/2013: THIS CASE CONCERNS A PT WHO DEVELOPED RIGHT KNEE PATELLOFEMORAL JOINT DISEASE AFTER RECEIVING HYLAN G-F 20 FOR OSTEOARTHRITIS OF RIGHT KNEE. ROLE OF UNDERLYING DISEASE PROVIDES AN ALTERNATE EXPLANATION.

    Description of Event or Problem · 1

    SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM AN INVESTIGATOR REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6) WITH RIGHT KNEE OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6), 2013, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION AT A DOSE OF 02 ML ONCE PER WEEK INTO THE RIGHT KNEE (ROUTE OF ADMINISTRATION NOT PROVIDED). ON (B)(6) 2013, THE PT RECEIVED THE SECOND SYNVISC INJECTION. ON (B)(6) 2013, THE PT RECEIVED THE THIRD SYNVISC INJECTION. IT WAS REPORTED THAT THE PT HAD PAIN IN RIGHT KNEE AND LIMITATION OF ACTIVITY FOR ONE YEAR. SO THE PT WAS HOSPITALIZED ON (B)(6) 2013 AND ON (B)(6) 2013, THE PT UNDERWENT ARTHROSCOPIC SURGERY. THE POSTOPERATIVE DIAGNOSIS WAS RIGHT KNEE PATELLA JOINT DISEASE, LATERAL MENISCAL CYST AND MEDIAL MENISCUS INJURY. ON (B)(6) 2013, THE PT WAS DISCHARGED FROM THE HOSPITAL WITH NO MEDICATION TREATMENT. AT THE TIME OF THE REPORT, THE PT HAD NOT YET RECOVERED FROM RIGHT KNEE PATELLA JOINT DISEASE. THE OUTCOME FOR THE EVENTS OF LATERAL MENISCAL CYST AND MEDIAL MENISCUS INJURY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF RIGHT KNEE PATELLA JOINT DISEASE WAS MODERATE. THE INTENSITY FOR THE EVENTS OF LATERAL MENISCAL CYST AND MEDICAL MENISCUS INJURY WAS NOT PROVIDED. THE REPORTING INVESTIGATOR ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF RIGHT KNEE PATELLA JOINT DISEASE AS UNRELATED AND DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF LATERAL MENISCAL CYST AND MEDIAL MENISCUS INJURY. F/U INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN REGARDING THE PT'S MEDICAL HISTORY AND HER CLINICAL COURSE. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR MODERATE RIGHT KNEE OSTEOARTHRITIS (DURATION: FIVE YEARS; X-RAY GRADE 3; WITH NO PRIOR EFFUSION, JOINT NARROWING AND OSTEOPHYTES). ON (B)(6)2013, THE PT DEVELOPED RIGHT KNEE PAIN AND LATERAL MENISCAL CYST. A DIAGNOSIS OF RIGHT KNEE PATELLOFEMORAL JOINT DISEASE WAS MADE BY THE PHYSICIAN (PREVIOUSLY REPORTED AS RIGHT KNEE PATELLA JOINT DISEASE). ON (B)(6) 2013, ARTHROSCOPIC SURGERY OF RIGHT KNEE WAS PERFORMED DURING WHICH MENISCAL CYST WAS DRAINED, MEDICAL MENISCUS WAS REPAIRED AND ALL DAMAGED JOINT SURFACE WERE REPAIRED (SUCH THAT SURFACES WERE SMOOTHENED). ON AN UNSPECIFIED DATE IN 2013 (POST-OPERATIVELY), SHE WAS TREATED WITH ANTI-INFLAMMATORY (UNSPECIFIED) DRUGS AND FLUID SUPPLEMENTATION. SHE WAS INSTRUCTED REST FOR THREE MONTHS, TO PERFORM FUNCTIONAL EXERCISE DAILY AND BANDAGE FOR THREE WEEKS. IT WAS REPORTED THAT POSSIBLE PRECIPITATING FACTOR FOR THE EVENTS OF RIGHT KNEE PATELLA JOINT DISEASE, LATERAL MENISCAL CYST AND MEDIAL MENISCUS INJURY (NOW SUBSUMED UNDER RIGHT KNEE PATELLOFEMORAL JOINT DISEASE) WAS RIGHT KNEE JOINT DEGENERATION. AT THE TIME OF THE REPORT, PT HAD NOT YET RECOVERED FROM THE EVENT OF "RIGHT KNEE PATELLOFEMORAL JOINT DISEASE/PAIN OF RIGHT KNEE". RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE LIDOCAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE ATROPINE SULFATE, EPHEDRINE HYDROCHLORIDE, GLUCOSE AND SODIUM CHLORIDE INJECTION, RINGER LACTATE (SODIUM LACTATE) AND MIDAZOLAM. F/U INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN REGARDING CLINICAL COURSE. IT WAS CONFIRMED THAT THE PT DID NOT RECEIVE ANY ANTI-INFLAMMATORY DRUG POST-OPERATION (EARLIER REPORTED AS A TREATMENT MEDICATION). AT THE TIME OF THE REPORT, THE PT HAD NOT YET RECOVERED FROM THE EVENT. F/U INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN REGARDING THE PT'S CLINICAL COURSE. THE REPORT TYPE OF CASE WAS UPDATED FROM "UNSOLICITED" TO "SOLICITED". THE PT WAS ENROLLED IN STUDY (B)(6) AND THE PT ID WAS (B)(6), IT WAS REPORTED THAT THE INVESTIGATOR CONTACTED THE PT ON (B)(6) 2013 AND REPORTED THAT THE PT SAID STILL HAD SWELLING AND PAIN OF RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505835 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) N12015

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R LIDOCAINE| HYDROCHLORIDE| MIDAZOLAM| EPHEDRINE HYDROCHLORIDE| ROPIVACAINE HYDROCHLORIDE| ATROPINE SULFATE| GLUCOSE INJECTION| SODIUM LACTATE| SODIUM CHLORIDE| PREV MEDS = UNK