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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Bruise/Contusion (1754); Erythema (1840); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Chills (2191); Dizziness (2194); Excessive Tear Production (2235); Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); Irritability (2421); Sweating (2444); Ambulation Difficulties (2544); No Code Available (3191)
Event Type  Injury  
Event Description
Device malfunction [device malfunction], has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait [gait inability], patellofemoral irritability [patellofemoral pain syndrome], knee swelling [knee swelling], right and left knee peripatellar crepitation [joint crepitation], pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness [arthralgia], right knee moderate effusion [effusion (r) knee], some stiffness secondary to swelling [joint stiffness]. Case narrative: based on additional information received on 10-may-2018 from a physician, the case was medically confirmed. Also the case initially considered as non-serious was upgraded to serious as an important medical event of device malfunction was added. This case is cross referred with the case (b)(4) (same patient). This unsolicited case from united states was received on 03-jan-2018 from patient. This case concerns a (b)(6) female patient who received treatment with synvisc one and after unknown latency had has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait, had pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness, had right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, right and left knee peripatellar crepitation. Also device malfunction was reported for this lot number. Medical history included bilateral knee arthritis, increasing pain as well as pain at night (pain described as aching, exhausting, miserable, nagging, penetrating, sharp, shooting, tender, throbbing and tiring), worsens with walking/activity, improves with rest, worsens with climbing stairs, worsens with descending stairs, improves with medication (takes edge off but not completely - aleve) and worsens with sleeping, moderate effusion in both knees, baker's cyst in left knee, tricompartmental djd worse in the medial and patellofemoral compartments with degenerative medial meniscal tear in left knee, tricompartmental degenerative joint disease (djd) with edema in the medial tibial plateau, medial femoral condyle and tibial spine with significant patellofemoral degenerative changes and degenerative medial meniscal tear in right knee and diffuse anterior medial knee pain, l tibial plateau treated nonoperatively in 2006, arthroscopy of the right, left knee in 2010 (2014), night sweats, nausea, heartburn, swelling lower extremities, muscle weakness, stiffness and joint pain. The patient previously had fracture repair of the left knee. Other previous surgeries include hysterectomy in 2004. Patient had continued pain, morning stiffness, pain with standing/sitting long periods, pain with walking long periods, recurrent swelling, weakness, tenderness, stiffness and instability, injury. Patient drinks alcohol socially (1-2 drinks per week). She never used tobacco. Patient was allergic to diphenhydramine hydrochloride (benadryl), codeine, minocycline, morphine, penicillins, sulfa (sulfonamides), synvisc, tetracyclines and naproxen (vimovo). Prior treatments included anti-inflammatory (aleve twice a day helps somewhat), cane use (no), brace use (patellar sleeve brace uncomfortable), physical therapy (did not help). Patient had received synvisc one injection before on (b)(6) 2017 in left knee and cortisone in (b)(6) 2017. Family history included asthma in father, coronary artery disease and heart disease in father and grandmother and high cholesterol, hypertension, rheumatoid arthritis, rheumatic fever and kidney disease in mother. On (b)(6) 2017, magnetic resonance imaging (mri) of left knee showed mild osteoarthritis, complex tears in the posterior horn and root of the medial meniscus, mcl and acl strain, large joint effusion, bone contusion in the medial femoral condyle and tibial plateau and large popliteal cyst. On the same day, mri of right knee showed complex tears in the posterior horn, body and root of the medial meniscus, mcl strain, moderate osteoarthritis and chondromalacia patella, large joint effusion and bone contusion in the medial femoral condyle, tibial plateau and proximal mid tibia. A microfracture could not be excluded. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 48 mg (lot number: 7rsl021; frequency and expiry date: not reported) in both knees for osteoarthritis. The patient tolerated the procedure well. Bilateral knees were aspirated 20 cc of clear yellow synovial fluid prior to synvisc-one injections. On (b)(6) 2017, patient was complaining of significant pain with difficulty walking, big swollen knee. She was afebrile. Physical examination of bilateral knees demonstrates antalgic gait and range of motion 10-90 degrees due to pain. Afebrile and 3+ joint effusions stable. 2+ distal pulses, intact sensation and motor function, no calf swelling and no edema. Patient reported that the patient walks like a penquin and had never had anything like the experience she was having now. Patient mentioned how much pain she was in. On (b)(6) 2017, x-ray of both knees was done that showed medial joint space narrowing with marginal osteophyte formation, periarticular sclerosis and cysts bilaterally. Right knee showed diffuse global tenderness, effusion, lateral joint line tenderness. There was medial joint line tenderness, peripatellar pain and peripatellar crepitation in both knees. The patient displayed antalgic gait on right and antalgic gait on left. Also there was maculopapular erythematous lesions to bilateral knees, posterior fullness, negative posterior drawer. On (b)(6) 2018, patient complained primarily some pain and persistent swelling in the right knee. Her left knee was doing much better. On the same day, patient's right knee shows moderate effusion. Patient had no erythema, warmth or signs of infection. Patient had some stiffness secondary to swelling. Mild diffuse joint line pain as well as patellofemoral irritability, no calf pain or swelling, negative homans1 sign, mildly antalgic gait. On (b)(6) 2018, after discussion with the patient regarding treatment options, a mutual decision was made to proceed with an aspiration/injection of the right knee joint. The right knee was sterilely prepped, and 30 cc of blood tinged clear synovial fluid. Fluid sent for routine studies including gram stain, cell count, crystals, protein, glucose, anaerobic and aerobic, afb and fungal cultures. The knee was then injected with a mixture of 4 cc 1% lidocaine, 4 cc, 0. 25% bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog) 80 mg. The patient tolerated the procedure well; post injection instructions were given. No obvious signs of infection based on fluid aspirate. Patient was reassured that there was no acute need for surgical intervention. Patient was scheduled for follow-up in two to three weeks or sooner should swelling persist or worsen. The patient was also aware to look for signs of infection such as fever, redness, increasing pain, etc. Corrective treatment: aspiration, mixture of 4 cc 1% lidocaine, 4 cc 0. 25% marcaine and kenalog 80 mg for right knee moderate effusion; not reported for other events outcome: unknown for all events. A pharmaceutical technical complaint was initiated with (b)(4). 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction. Additional information was received on 09-jan-2018 from the patient. Event of trouble walking was updated to trouble walking/can't walk and having challenges beyond words/walks like a penquin. Event of pain was added. Clinical course was updated and text amended accordingly. Additional information was received on 01-mar-2018. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly. Additional information was received on 10-may-2018 from a physician. The case was medically confirmed. The case was upgraded to serious. Patient's demographics were added. Medical history, past drug were added. Additional events of right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, device malfunction right and left knee peripatellar crepitation were added along with details. The event term has trouble walking/can't walk and having challenges beyond words/walks like a penquin was updated to has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait and pain was updated to pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness. Dose, indication and lot number of synvisc one was added. Investigation summary was updated. Related case was added. Clinical course was updated and text was amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key7582948
MDR Text Key111147729
Report Number2246315-2018-00483
Device Sequence Number0
Product Code MOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 03/26/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1
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