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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Loss of Range of Motion (2032); Weakness (2145); Tingling (2171); Cramp(s) (2193); Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); Malaise (2359)
Event Date 12/04/2017
Event Type  Injury  
Event Description
Possible cellulitis of both knees/cellulitis [cellulitis of foot] ([redness], [foot edema], [localised feeling of warmth], [condition aggravated]), device malfunction [device malfunction], recurrent pain in feet [painful feet], paralysis of arms or legs [diplegia], no standing/walking for extended period of time/lot of problem with walking/antalgic gait [gait disturbance], [difficulty in standing], recurrent pain in knee/tenderness over medial compartment of knee/joint pain [pain in knee] ([condition aggravated]), not able to work/activities limited/problems with social activities [activities of daily living impaired], genu varum of 5 degree/deformity [genu varum], dyspnea on exertion/shortness of breath [exertional dyspnea], difficulty getting good sleep [poor quality sleep], numbness or tingling of arms or legs [numbness of extremities], fatigue [fatigue], weakness [weakness], muscle weakness [muscle weakness], loss of appetite [appetite lost], stuffy nose [nasal stuffiness], cough [cough], muscle pain [muscle pain], cramps [cramps], feeling sick [feeling sick], headache [headache], numbness or tingling of arms or legs [tingling of extremity], decreased range of motion [joint range of motion decreased], minimal inflammatory changes [post procedural inflammation], swelling of joints [joint swelling], questionable effusion/effusion, right knee [effusion (l) knee], stiffness of right knee [joint stiffness]. Case narrative: this case was cross referenced with (b)(4) (same patient). 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) male patient who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and experienced possible cellulitis of knees/cellulitis (latency: 6 days), recurrent pain in feet, recurrent pain in knee/tenderness over medial compartment of knee, not able to work/activities limited, no standing/walking for extended period of time, genu varum of 5 degree/deformity, dyspnea on exertion/shortness of breath, weakness, difficulty getting good sleep, no standing/walking for extended period of time/lot of problem with walking/antalgic gait, decreased range of motion and questionable effusion/effusion, right knee, swelling of joints, numbness or tingling of arms or legs, headache, feeling sick, cramps, muscle pain, cough, stuffy nose, loss of appetite, muscle weakness, fatigue, paralysis of arms or leg, minimal inflammatory changes, stiffness of right knee. A device malfunction was noted in the reported batch number. The patient's past medical history included sleep apnoea, thyroidectomy, primary osteoarthritis of right/left knee other than total joint replacement, arthroscopic knee surgery, former smoker, caesarean section in (b)(6) 1971, also in 1974, staphylococcal skin infection, colonoscopy in (b)(6) 2006 and tonsillectomy. The patient's past medical treatment included synvisc one on (b)(6) 2017 in bilateral knee. The patient's family history included heart disease, cancer (unspecified), hypertension, arthritis and high cholesterol with brother/mother. The patient's past vaccination(s) was not provided. At the time of the event, the patient had ongoing hypertension since (b)(6) 2017, primary osteoarthritis of right/left knee, occasional alcohol use, left first toe mtp osteoarthritis, chronic venous stasis disease, lumbar degenerative disk disease notably l1-2 and l2-3, hyperlipidaemia, mild aortic valve stenosis, obesity, liver function test abnormal, gastroenteritis, chronic acquired lymphedema, neuropathic pain, inflammatory polyarthritis, polyarticular gout/gout of lower extremities, systemic inflammatory response syndrome and metallic foreign bodies in both hands. Concomitant medications included prednisone (deltasone); amlodipine besilate, benazepril hydrochloride (lotrel); acetylsalicylic acid (aspirin); vitamin d2; hydrochlorothiazide (hydrodiuril); levothyroxine sodium (synthyroid); niacin; potassium chloride (k-dur); sennoside a+b (senna laxative); simvastatin (zocor); allopurinol (zyloprim); hydrocodone bitartrate, paracetamol (hydrocodone/acetaminophen) and oxycodone hydrochloride, paracetamol (percocet) for pain; indomethacin and codeine phosphate, paracetamol (tylenol with codeine). On (b)(6) 2017, the patient had hylan g-f 20, sodium hyaluronate, intra-articular injection at an unknown dose, once (lot - 7rsl021, may 2020) for osteoarthritis of right knee. Patient developed pain all over as well as cellulitis shortly after the injection (latency: 6 days). It was reported that hylan g-f 20, sodium hyaluronate injection seemed to exacerbate knee and feet symptoms. On (b)(6) 2017, patient was hospitalized for cellulitis of lower limb. There was no evidence of deep vein thrombosis in lower limbs. On (b)(6) 2017, patient was discharged from hospital. On (b)(6) 2017, patient reported to have elevated white count, increased warmth or redness in the feet area. Patient had not worked since the day prior ((b)(6) 2017) to the injection. Also, patient had no effusion and 1+ edema in the ankles. On (b)(6) 2017, patient was hospitalized for recurrent pain in feet as well as in knee. During the stay, patient was initially placed on antibiotics, but after consultation, antibiotics were discontinued with no obvious site of infection. Patient had pain in legs, particularly in feet and knee and was not able to work because of this. Patient was discharged on (b)(6) 2017. On (b)(6) 2018, patient was noted to have dyspnea on exertion. On (b)(6) 2018, patient was noted to be in wheelchair and had questionable effusion (left greater than right), 1+ edema in feet and had no sign of redness, warmth or any sign of any lymphangitis or cellulitis to lower extremity. He had no obvious sign of sepsis or acute motor deficits. Patient was injected in left knee with methylprednisolone acetate (depo-medrol) and lidocaine. Patient had short term disability claim as he could not stand or walk for extended periods of time and no climbing. The methylprednisolone injection improved the pain to only having some mild pain with activity. Patient still sometimes used walker at home was in a wheelchair. On (b)(6) 2018, review of system noted difficulty with good night sleep, more than 10 pound weight loss, feeling sick, headache, fatigue, loss of appetite, unusual bruising or bleeding, stuffy nose, shortness of breath, cough, muscle pain, aches or cramps, muscle weakness, paralysis, numbness or tingling of arms or legs, swelling of ankles and other joints, joint pain and problems with social activities. The edema in feet was resolved as noted on visit on (b)(6) 2018. On (b)(6) 2018, it was noted that patient was walking with mild antalgic gait, had tenderness over the medial compartment of knees with slight genu varum of 5 degrees. On (b)(6) 2018, patient underwent total knee replacement for right knee. There was minimal inflammatory changes due to knee replacement. On (b)(6) 2018, stiffness was noted in right knee. Relevant laboratory test results included: alanine aminotransferase (4 - 41 u/l) - on (b)(6) 2018: 48 u/l [high], anion gap (5 - 15) - on (b)(6) 2018: 21 [high], aspartate aminotransferase (4 - 37 u/l) - on (b)(6) 2018: 39 u/l [high], blood alkaline phosphatase (40 - 129 u/l) - on (b)(6) 2018: 172 u/l [high], blood chloride (96 - 108 meq/l) - on (b)(6) 2018: 91 meq/l [low], blood cholesterol (3 - 200 mg/dl) - on (b)(6) 2018: 211 mg/dl [high], blood glucose (70 - 100 mg/dl) - on (b)(6) 2018: 107 mg/dl [high]; on (b)(6) 2018: 209 mg/dl [high], blood triglycerides (0 - 150 mg/dl) - on (b)(6) 2018: 239 mg/dl [high], blood uric acid (3. 4 - 7. 0 mg/dl) - on (b)(6) 2018: 7. 4 mg/dl [high]; on (b)(6) 2018: 8. 6 mg/dl [high], c-reactive protein (0. 00 - 0. 40 mg/dl) - on (b)(6) 2018: 15. 86 mg/dl; on (b)(6) 2018: 1. 49 mg/dl [high]; on (b)(6) 2018: 1. 18 mg/dl [high], haemoglobin (13. 0 - 18. 0 g/dl) - on (b)(6) 2018: 12. 6 g/dl [low], low density lipoprotein - on (b)(6) 2018: 102 mg/dl [high; reference: <100], lymphocyte percentage (20. 0 - 40. 0 %) - on (b)(6) 2018: 15. 1 % [low]; on (b)(6) 2018: 14. 5 % [low], mean cell haemoglobin concentration (32 - 36 %) - on (b)(6) 2018: 31 % [low], monocyte count (0. 0 - 0. 8 10*3/ul) - on (b)(6) 2018: 1. 2 10*3/ul [high], neutrophil count (1. 8 - 7. 0 10*3/ul) - on (b)(6) 2018: 8. 0 10*3/ul [high]; on (b)(6) 2018: 8. 3 10*3/ul [high], red blood cell sedimentation rate (0 - 20 mm/h) - on (b)(6) 2018: 75 mm/h [high]; on (b)(6) 2018: 46 mm/h [high], white blood cell count (5. 0 - 10. 0 10*3/ul) - on (b)(6) 2018: 11. 1 10*3/ul [high]; on (b)(6) 2018: 10. 4 10*3/ul [high], corrective treatment: gabapentin for possible cellulitis of both knees/cellulitis; wheelchair, methylprednisolone acetate, lidocaine, total knee replacement for recurrent pain in knee/tenderness over medial compartment of knee/joint pain, wheelchair for no standing/walking for extended period of time/lot of problem with walking/antalgic gait; not reported for rest. Outcome: recovered for possible cellulitis of both knees/cellulitis, unknown for rest. 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 criteria: hospitalization, disability, intervention required for device malfunction, recurrent pain in knee/tenderness over medial compartment of knee/joint pain; medically significant for paralysis of arms or legs, cellulitis; hospitalization for possible cellulitis of both knees/cellulitis; hospitalization and disability for recurrent pain in feet; disability for no standing/walking for extended period of time/lot of problem with walking/antalgic gait.
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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 Key8352571
MDR Text Key136604935
Report Number2246315-2019-00062
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? No
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