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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Cramp(s) (2193); Urticaria (2278); Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); Sleep Dysfunction (2517); No Code Available (3191)
Event Date 11/20/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]; inability to weightbear [weight bearing difficulty] ; gradually increased in pain/pain 10/10 [pain knee] ; swelled up/knee gradually increased in swelling [swelling of l knee]; left knee drained/effusion left knee [effusion (l) knee] ; eczema [eczema] ; possible allergic contact dermatitis [allergic contact dermatitis] ; hives/idiopathic urticaria [idiopathic urticaria] ; allergic rhinitis [allergic rhinitis] ; pain into the thigh/tender over the calf/hands painful [pain in extremity] ; numbness in her toes [numbness in toes]; left calf swelling/swelling into thigh [swelling]; right fifth finger is inflamed [inflammation localised] ; not sleeping well [sleep unwell]; ast low [ast low]; alt low [alt low] ; platelets low [platelets decreased]; mcv low [mean cell volume low] ; synovial fluid red color/ slightly hazy/nucleated cells high [synovial fluid analysis abnormal]; knee was giving out [joint instability] ; clicking constant [joint clicking] ; lot of calf and leg cramps [cramps of lower extremities] ; doesn't feel well [feeling unwell] ; felt she was allergic [allergy] ; aggravated by sweating and change in temperature [condition aggravated] ; erythema [erythema] ; itching [itching]. Case narrative: initial information received from united states on 07-feb-2019 regarding an unsolicited valid serious legal case received from a lawyer. This case involves a (b)(6) years old female patient who experienced inability to weightbear, gradually increased in pain/pain 10/10, swelled up/knee gradually increased in swelling (latency: 0 day), knee was giving out (latency: 16 days), left knee drained/effusion left knee (latency: 1 month), eczema, possible allergic contact dermatitis, dermatitis, hives/idiopathic urticaria, allergic rhinitis, pain into the thigh/ tender over the calf/hands painful, numbness in her toes, left calf swelling/swelling into thigh, right fifth finger is inflamed, not sleeping well (latency: unknown), ast low, alt low (latency: 3 months 22 days), platelets low, mcv low (latency: 1 month 2 days), synovial fluid red color/ slightly hazy /nucleated cells high (latency: 1 month), clicking constant, lot of calf and leg cramps, doesn't feel well and felt she was allergic (latency: unknown), after she was treated with hylan g-f 20, sodium hyaluronate (synvisc one). A device malfunction was noted in the reported batch number. The patient's past medical history included lower back pain, generalized stiffness: loosens up if walks around if sits she freezes up, acid reflux, former smoker (stopped (b)(6) 2017, half pack/day), inflammatory polyarthropathy, intervertebral disc degeneration in lumbar region, crepitus and mild swelling in right knee and 3/8 swelling in left knee, stomach ulcer, shortness of breath, migraine, burning sensation going to the thigh in left leg, walked with antalgic gait, depression (major depressive disorder, single episode), anxiety, bronchitis chronic, caesarean section on (b)(6) 1993, (b)(6) 1999, and (b)(6) 2001, gall bladder removed in (b)(6) 2007, cavernous hemangioma, irregular periods, thyroid nodule, uterine fibroid surgery, urticaria (started mtx last time but got very sick with nausea, vomiting, gl upset and worse refiux after the second week and didn't finish it), decreased sense of smell and occasional episodes of wheeze and using pro-air inhaler for it. Patient had right knee hylan g-f 20, sodium hyaluronate injection on (b)(6)2015 and left knee hylan g-f 20, sodium hyaluronate injection on (b)(6) 2015 and had relief, small joint effusion on (b)(6) 2017. The patient's family history included hypertension with mother, father, ovarian cancer with mother, hypothyroidism with mother, maternal aunt, grandmother and heart disease with grandmother. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing bilateral knee, hip and ankle pain, diffuse joint pain, was positive for hla-b27 (human leukocyte antigen), knee osteoarthritis, allergy induced asthma for which patient was hospitalized in (b)(6) 2017 for 2 weeks, fibromyalgia, chronic fatigue, lyme disease, allergy to fish, shellfish, seafood, penicillin, levaquin, cipro, ceclor, bactrim, sulfa, percocet (almost all these drugs gave difficulty breathing & swelling of lip & rashes, with some anaphylactic type reactions), sleep apnea, primary localized osteoarthrosis, lower leg, acquired hypothyroidism, chronic constipation, anemia since 2016, caveronoma of left eye since (b)(6) 2017 with continued deterioration of vision presumably from this growth: had three mri, varicose veins in right knee, right knee swelling and chronic nasal congestion, bilateral moderate medial compartment joint space narrowing and tibial spine and patellofemoral spurring changes since (b)(6) 2017. Concomitant medications included folic acid, prednisone, montelukast sodium, omeprazole, salbutamol sulfate (proair hfa), lansoprazole (prevacid), clarithromycin (claritin), methotrexate. On (b)(6) 2017, the patient had hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 6 ml, once in left knee (lot - 7rsl021, may 2020) for left knee osteoarthritis and primary localized osteoarthrosis, lower leg. On the same day, starting in night, left knee gradually increased in swelling, firmness, pain, and inability to weight bear, denied fever and patient was feeling worse. On (b)(6) 2017, pain of left knee was 10/10 and patient was walking with crutches and was brought in a wheelchair. On same day, patient had cortisone shots in left knee. On an unknown date, after unknown latency, patient had pain in thigh and numbness in the toes. On (b)(6) 2017, patient reported to be feeling 50% better but still had swelling and pain in thigh and numbness in toes. By (b)(6) 2017, patient was feeling better until yesterday and was off the crutches. But on (b)(6) 2017, patient felt worse, had to go back to the crutch because the knee was giving out and her left great toe was going numb. Patient had pain in entire knee and constant clicking (latency: unknown). On (b)(6) 2017, patient was not using crutches at all, complained of not feeling well and her left eye sight was worsening which she felt was after the hylan g-f 20, sodium hyaluronate injection. Patient had left knee effusion (latency: 1 month), was tender over left calf and had positive homans test and left knee was drained. Patient had venous doppler from advanced imaging which was negative for dvt (deep vein thrombosis). On the same day, after latency of 1 month, the synovial fluid was red (reference: yellow), slightly hazy (reference: clear) and had 792 nucleated cells/ul (high; reference: 0-200 cells/ul). There was no growth seen on gram stain. On (b)(6) 2017, after latency of 1 month 2 days, hemoglobin was 10. 6 g/dl (low; reference: 11. 1-15. 9 g/dl), hematocrit was 33. 7 % (low; reference: 34. 0-46. 6 %), mcv was 76 (low; reference: 79-97), mch was 23. 8 (low; reference: 26. 6-33. 0 pg) and platelets were 145 x10e3/ul (low; reference: 150-379 x10e3/ul). On an unknown date, hands were painful, right fifth finger was inflamed, not sleeping well, had hives for more than 6 weeks (idiopathic urticaria), dermatitis aggravated by sweating and change in temperature, erythema, eczema and itching had allergic rhinitis. Patient had possible allergic contact dermatitis. Corrective treatment: cortisone shots, ice, elevation, crutches, rest, betamethasone sodium phosphate (celestone) for inability to weightbear, gradually increased in pain/pain 10/10, swelled up/knee gradually increased in swelling; montelukast sodium (singulair), clarithromycin, diphenhydramine hydrochloride (benadryl) for hives/idiopathic urticaria; mometasone furoate (flonase) nasal spray for allergic rhinitis; unknown for rest. Outcome: not recovered for swelled up/knee gradually increased in swelling, recovered for inability to weightbear, unknown for rest. Seriousness criteria: intervention required and disability for inability to weightbear, gradually increased in pain/pain 10/10, swelled up/knee gradually increased in swelling, device malfunction. A product technical complaint (ptc) was initiated for synvisc one. Batch number: 7rsl021; global ptc number: (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 was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Follow up received on 13-feb-2019. Global ptc number added. Text amended accordingly.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
bridgewater 08807
MDR Report Key8352530
MDR Text Key136603452
Report Number2246315-2019-00053
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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: 02/19/2019 Patient Sequence Number: 1