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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Erythema (1840); Muscle Spasm(s) (1966); Myocardial Infarction (1969); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 07/31/2018
Event Type  malfunction  
Event Description
Device malfunction [device malfunction], myocardial infarction [myocardial infarction], spasm [spasms], crepitus during range of motion [joint crepitation], could not walk for a week [unable to walk] , some swelling [swelling of l knee], redness [injection site joint redness], joint line tenderness/knee tender diffusely/knee still hurts/horrible pain in knee [joint tenderness], side effect [unevaluable event]. Case narrative: initial information received from united states on 23-jan-2019 regarding an unsolicited valid serious malfunction 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 gabapentin (neurontin) and after unknown latency experienced spasm, crepitus during range of motion, could not walk for a week, some swelling, redness, joint line tenderness/knee tender diffusely/knee still hurts/horrible pain in knee and side effect and after 8 months 4 days had myocardial infarction. A device malfunction was noted in the reported batch number of hylan g-f 20, sodium hyaluronate. The patient's past medical history included right reverse shoulder replacement on (b)(6) 2017, right total knee replacement in (b)(6) 2015, bilateral neck pain that radiates into arms, right worse than left: significant cervical neck pain exacerbated with flexion and extension, arm pain, left cuff revision on (b)(6) 2017, cuff repair in (b)(6) 2015, sharp, aching, throbbing pain also numbness tingling into fingers, mildly antalgic gait, central obesity, left trochanteric bursitis, infection complications, trigger fingers release, anxiety, arthritis, seizure disorder, cervical fusion with neck pain, occasional alcohol intake, wrist arthroscopy, left bone cyst, elbow surgery, onychomycosis since (b)(6) 2016, hypogonadism since (b)(6) 2017, dyslipidaemia since (b)(6) 2017, depressive disorder since (b)(6) 2016, myoclonus since (b)(6) 2016, restless legs syndrome since (b)(6) 2017, chronic pain syndrome since (b)(6) 2017, epilepsy since (b)(6) 2017, neuropathy knees down since (b)(6) 2017, fatigue since (b)(6) 2017, impaired fasting glycemia since (b)(6) 2017, brachial neuritis, extracorporeal shock wave lithotripsy, cystoscopy, revision distal clavicle excision and subacromial decompression, arthroscopy left shoulder, stiffness of left shoulder, hip pain for which had injection on (b)(6) 2017 and had some relief, revision of left shoulder/left reverse replacement with aggressive debridement on (b)(6) 2018, blurry vision, nasal congestion, seasonal allergy, cold intolerance. The patient's family history included diabetes mellitus with father and essential hypertension with father, mother. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing right shoulder pain, left knee degenerative joint disease, pain in left knee and pain along the joint line, worse with activity, relieved by rest and patient had steroid injection (b)(6) 2017 and did not had much relief from it, right shoulder arthritis, instability with cuff tear, cervical degenerative disc disease, activities gone down, left shoulder pain with left reverse replacement in (b)(6) 2018, glenohumeral osteoarthritis, left shoulder, carpal tunnel syndrome, essential hypertension, drug allergy with depakote, ativan, flexeril and ace inhibitors allergy, wrists arthritic, shoulder infection/left prosthetic infection in 2018 after the replacement of left shoulder and patient was on iv antibiotics, shoulder swelling and night sweats. Concomitant medications included bisoprolol; hydrochlorothiazide for essential hypertension. On nov-27-2017, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection in the left knee at an unknown dose, once (lot - 7rsl021, (may 2020) for left knee degenerative joint disease. On (b)(6) 2017, on the visit patient stated that he had reaction to hylan g-f 20, sodium hyaluronate, said he could not walk for a week because of that knee (onset and latency: unknown). It was reported that hylan g-f 20, sodium hyaluronate messed up the knee on the left, so maybe he can have another product put into that knee. On (b)(6) 2018, patient stated that he did note that he had some swelling following the injection and mild redness (onset and latency: unknown), but this has completely resolved. He has had no fevers, chills. His knee itself has no warmth or redness. He has no effusion. He had good stable range of motion, no pain with range of motion. On (b)(6) 2018, patient stated that he had noticed no real changes in his left knee, no redness, swelling or unusual tenderness. Patient denies fevers, chills, numbness, weakness or tingling and would like to discuss a left total knee replacement sometime later this year. Concerning the left knee, range of motion was 0 to 120 degrees, with crepitus during range of motion, he was neurovascularly intact, no swelling and did had joint line tenderness. He had no calf tenderness. On (b)(6) 2018, patient stated that his knee still hurts where he needs kind of a knee replacement, left knee was tender diffusely. On the same day, the patient started taking gabapentin (neurontin) at an unknown dose, at night for pain. On (b)(6) 2018, patient stated that he would have his left knee replaced and was taking tramadol, hydrocodone bitartrate, paracetamol (norco) and tizanidine hydrochloride (zanaflex) for spasm (onset and latency: unknown). Patient was tried to help with at night for worsening symptoms with gabapentin but he said it caused side effect so he discontinued that. On (b)(6) 2018, the ecg (electrocardiogram) showed myocardial infarct (latency: 8 months 4 days), incomplete right bundle-branch block no longer present compared to ecg on (b)(6) 2016. Relevant laboratory test results included: anion gap (10. 0 - 17. 0 unk) - on (b)(6) 2018: 8. 9 unk [low time: 16:33] blood glucose (74 - 106 mg/dl) - on (b)(6) 2018: 109 mg/dl [high time: 16:33] c-reactive protein (0. 00 - 0. 30 mg/dl) - on (b)(6) 2018: 4. 02 mg/dl [high time: 16:33] red blood cell sedimentation rate (0 - 15 mm/h) - on (b)(6) 2018: 54 mm/h [high time: 16:33] final diagnosis was mild redness, some swelling, could not walk for a week, not applicable device malfunction, side effect, myocardial infarction, joint line tenderness/knee tender diffusely/knee still hurts/horrible pain in knee, crepitus during range of motion and spasm. Action taken: drug withdrawn for gabapentin. Corrective treatment: tramadol, hydrocodone bitartrate, paracetamol, tizanidine hydrochloride (zanaflex) for spasm; tramadol hydrochloride, hydrocodone bitartrate, paracetamol, gabapentin, tizanidine hydrochloride for joint line tenderness/knee tender diffusely/knee still hurts/horrible pain in knee; not reported for rest of the "even". Outcome: unknown for crepitus during range of motion, myocardial infarction, spasm, side effect; not recovered / not resolved for joint line tenderness/knee tender diffusely/knee still hurts/horrible pain in knee, recovered for rest of the events except device malfunction. Seriousness criteria: medically significant for device malfunction and myocardial infarction. A product technical complaint was initiated on (04-feb-2019 for synvisc one (lot number 7rsl021) with 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 information received on 30-jan-2019. No new information. Follow up information received on 04-jan-2019. No significant information was received.
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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 Key8333088
MDR Text Key139076024
Report Number2246315-2019-00036
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
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 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
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
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1