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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Chest Pain (1776); Erythema (1840); Fatigue (1849); Unspecified Infection (1930); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Loss of Range of Motion (2032); Swelling (2091); Hypoesthesia, Foot/Leg (2354); Arthralgia (2355); Joint Swelling (2356); Neck Pain (2433); Sleep Dysfunction (2517); No Code Available (3191)
Event Date 11/13/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction], swelling/left knee was double its normal size [knee swelling], hurts to walk/could not walk [difficulty in walking], joint infection [joint infection], excruciating pain/pain is worsened with activity [knee pain], congestion [congestion pulmonary], redness in left knee [redness], itching in eyes [itching eyes], cough [cough], sleep has been greatly affected [sleep difficult], sciatica had flared [sciatica aggravated], rom is limited due to the pain [joint range of motion decreased], t wave abnormality [electrocardiogram t wave abnormal], neuropathy type pain [neuropathic pain], knee was mildly warm [joint warmth], eosinophil percentage high [eosinophil percentage increased], bilirubin total low [bilirubin total low], alkaline phosphatase high [alkaline phosphatase increased], spasms [spasms], limited weightbearing [weight bearing difficulty], left knee effusion [knee effusion]. Case narrative: based on additional information received on 04-jun-2018 from a health care professional, the case was medically confirmed. Also this case initially considered as non-serious was upgraded to serious as the serious events of device malfunction, excruciating pain, swelling/left knee was double its normal size (seriousness criteria: required intervention), hurts to walk/could not walk (seriousness criteria: disability) and joint infection (seriousness criteria: medically significant) were added. Initial information received on 12-feb-2018 regarding an unsolicited valid serious case from united states received from a lawyer. This case involves a (b)(6) female patient who was treated with hylan g-f 20, sodium hyaluronate (synvisc one) injection and on the same day had excruciating pain, swelling/ l knee was double its normal size and hurts to walk/could not walk, after 1 day had spasms and after 2 days had left knee effusion and after unknown latency sciatica had flared, congestion, cough, sleep has been greatly affected and itching eyes, after few days had redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, had limited weightbearing and neuropathy type pain, after 1 month and 28 days ecg was abnormal, after 2 months and 06 days alkaline phosphatase high, bilirubin total low and eosinophil percentage high. Also device malfunction was reported for this lot number. Patient's medical history included acute constipation, lower mid abdominal pain, sciatica, arrhythmias, primary osteoarthritis of left knee, hallux rigidus of both feet, back pain, gait problem, neck pain, neck stiffness, acute medial meniscus tear, left, locking, catching, snapping, crepitus in left knee, anxiety (unspecified), decreased concentration, bipolar disorder (in partial remission, most recent episode depressed: since (b)(6) 2017), asthma (childhood after having pneumonia resolved after treatment), colitis unspecified (hospitalized on (b)(6) 2013), diverticulitis (hospitalized (b)(6) 2013), pneumonia, hypothyroid, unspecified, osteoarthritis, rheumatoid arthritis, cholecystectomy, cystourethroscopy ((b)(6) 2014), excision morton's neuroma ((b)(6) 2015), partial joint replacement ((b)(6) 2008), knee arthroscopy (1976), laparoscopic cholecystectomy, laparoscopic colectomy partial w/anastamosis ((b)(6) 2014). Other surgical history included tendonitis, 10% disability in wrists in 1980's, left shoulder-bursa removal also clavicle ((b)(6) 2007), right knee arthroscopy (1977), right knee surgery (partial knee replacement in 2008), right shoulder rotator cuff and clavicle repairs, tarsal tunnel in the right foot two repairs, transfer adjacent tissue hand (on (b)(6) 2016). Concurrent conditions included panic disorder with agoraphobia and panic attacks in partial remission, depression, hypertriglyceridemia, gastroesophageal reflux disease, chronic pain in left foot (since (b)(6) 2013), neuroma, morton's (since (b)(6) 2013), morton's neuroma of third interspaces of both feet (since (b)(6) 2017), other specified dermatosis (since (b)(6) 2015), right finger pain (since (b)(6) 2016), finger stiffness right (since (b)(6) 2017), acute medial meniscus tear, left, initial encounter, post right partial knee replacement ((b)(6) 2017). Patient was allergic to epinephrine hydrochloride (epinephrine) (shortness of breath) and oxycodone (itching). Patient was positive for environmental allergies and food allergies. Patient was never a smoker and did not use alcohol. Family history included breast cancer (maternal grandmother), cancer, depression, hypertension and stroke (mother), dementia, hypertension and stroke (father), diabetes type ii, hypertension and hyperlipidemia in sister. Past drug included tdap ((b)(6) 2015) and varicella (varivax) ((b)(6) 2012). Concomitant medications included paracetamol (tylenol), acetylsalicylic acid (aspirin ec), buspirone hydrochloride (buspar), clonazepam (klonopin), diphenhydramine hydrochloride (benadryl), esomeprazole sodium (nexium), chondroitin sulfate sodium, glucosamine hydrochloride (glucosamine/chondroitin (chondroitin sulfate sodium;glucosamine hydrochloride)), lithium, lorazepam, ascorbic acid, betacarotene, copper, glycine max extract, herbal oil nos, oryza sativa oil, vaccinium myrtillus, vitamin e nos, xantofyl, zeaxanthin, zinc (lutein complex), gemfibrozil (lopid), levothyroxine sodium (synthroid), potassium chloride, gabapentin (neurontin). On (b)(6) 2017, at 15:49, the patient received treatment with intra-articular hylan g-f 20, sodium hyaluronate injection from anterolateral portal using 20 gauge needle, at a dose: 16 mg, once (lot number: 7rsl021 and expiry date: not provided) in left knee for primary osteoarthritis of left knee and chronic pain of left knee after betadine/cold spray. On the same day, by 09:00 pm her left knee was double its normal size with excruciating pain worse than her baseline and patient's pain on pain score was 6. Pain was so severe that she could not walk. On (b)(6) 2017, patient had pain, swelling and it hurts to walk. On (b)(6) 2017, patient's musculoskeletal knee examination showed effusion in left knee without redness. Patient was on wheel chair. Patient was advised that this was an adverse reaction to synvisc one. Patient should not have any further injections. Patient should continue ice and limited weight bearing until the pain resolved. This level of pain lasted almost two weeks, then lessened slightly probably as patient was given an oral dose of prednisolone to help with the pain and swelling. Patient's pain score on the same day was 10. As of (b)(6) 2017, patient had complaints of continued pain, swelling, difficulty walking and redness. It was reported that the patient had received the contaminated synvisc-one. On (b)(6) 2018, patient had left knee x-ray and was diagnosed with chronic pain of left knee, tricompartmental degenerative arthritis with mild narrowing of the medial compartment and tricompartmental osteophytosis. Diffuse demineralization was noticed. There was significant arthritis in knee. There was bone on bone joint space narrowing and early osteophyte formation. On the same day, patient's c-reactive protein was 0. 13 mg/dl (reference range: <
0. 60 mg/dl). Patient's pain on pain scale was 6 on same day. On the same day, patient's left knee musculoskeletal examination showed flexion: 80, extension: 10 and effusion 1+. It was reported that the patient needed assistance for ambulation and was at high risk for falls. On an unknown date, after unknown latency, patient had congestion, cough and itching eyes. On (b)(6) 2018, patient's pain on pain scale was 7/10 on same day and was sharp. As of (b)(6) 2018, the pain had plateaued but at a level much higher than her previous baseline and had persisted to this day. Patient's left knee was very mildly effused medially, otherwise unremarkable appearance; mild tenderness to palpation medially and superior to patella; no excessive warmth. Intact passive rom, but pain inhibition noted during active rom. No lower extremity edema. It was reported that patient's sleep had been greatly affected, and her sciatica had flared as a result (onset date and latency: unknown). Pain was worsened with activity. On an unknown date, few days after the injection, range of motion (rom) is limited due to the pain. No fevers/chills/night seats (but was still going through menopause). Patient was not taking any pain medications (could not take non-steroidal anti-inflammatory disease due to liver issues, and paracetamol (tylenol) did not help at all). It was reported that patient was now with persistent worsened left knee pain following possibly contaminated (with methylobacterium thiocyanatum) synvisc one injection to her left knee. On the same day, aspiration was requested with samples sent for culture and cytology, but there was no fluid in the knee on aspiration attempt. Since the orthopedician could not completely exclude infection (joint infection) (onset date: unknown) in this case, patient would start course of oral levofloxacin (levaquin) 750mg bid for 14 days. On (b)(6) 2018, patient had electrocardiogram (ecg) and the result was abnormal. Nonspecific t wave abnormalities, anterolateral leads were now present. When compared with ecg of (b)(6) 2014, sinus rhythm had replaced sinus bradycardia. On an unknown date, after unknown latency, patient had neuropathy type pain. As of (b)(6) 2018, patient was not interested in pursuing anything more with her neuropathy type pain. Patient's pain score was 7 on the same day. On (b)(6) 2018, patient presented for aspiration of left knee for possible infection and fluid would be sent for cultures. Under sterile conditions, knee was attempted to be aspirated with ultrasound guidance but no fluid was able to be aspirated. Needle was withdrawn and site was cleaned and dressed. Patient's physical exam on the same day showed that the left knee was without redness. Knee was mildly warm with trace effusion. Patellar mobility normal. Unable to flex knee past 60 degrees due to discomfort but was keeping the knee straight. On the same day, ultrasound did not showed any collectible area of fluid but did show thickened synovium. Patient's pain was 8 on pain score. On (b)(6) 2018, patient's eosinophil% was: 9. 5% (h) (normal range: 0-7. 0), bilirubin total: 0. 3 mg/dl (l) (normal range: 24-110), alkaline phosphatase: 122 u/l (h) (normal range: 3. 5-4. 8), corrective treatment: ice, rest, prednisone, methylprednisolone (medrol), anti -inflammatory and paracetamol for excruciating pain/chronic pain of left knee; ice, rest, prednisone, methylprednisolone (medrol) and anti -inflammatory for swelling; ice, rest, wheel chair and anti -inflammatory for hurts to walk, levofloxacin for join infection; not reported for other events outcome: recovered for redness, recovering for neuropathic pain and unknown for other events 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: required intervention for device malfunction, excruciating pain, swelling/left knee was double its normal size; disability for hurts to walk/could not walk, medically significant for joint infection additional information was received on 28-may-2018 from a health care professional. The case was medically confirmed. The case was upgraded to serious. Patient's age, weight and height were added. Medical history and concomitant medications were added. Treatment start and stop date, dose, frequency, indication and lot number was added. Action taken was updated from unknown to not applicable. The event of personal injury was deleted. Additional events of excruciating pain, swelling/ l knee was double its normal size, hurts to walk/could not walk, left knee effusion, sciatica had flared, congestion, cough, sleep has been greatly affected, itching eyes, redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, neuropathy type pain, ecg was abnormal, alkaline phosphatase high, bilirubin total low and eosinophil percentage high and device malfunction were added along with details. Clinical course was updated and text was amended accordingly.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7925411
MDR Text Key122311890
Report Number2246315-2018-00624
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
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: 10/02/2018 Patient Sequence Number: 1