Device malfunction [device malfunction].Gait and station abnormal/unable to walk four blocks without symptoms/unable to walk two flights of stairs without symptoms [unable to walk].Acute right otitis media [otitis media acute].Sinus infection [sinus infection] ([pain], [sensation of pressure]).May be bacterial infection [bacterial infection].Monocytes relative percentage increased [monocyte percentage increased].Pt low [prothrombin time decreased].Bilirubin total increased [bilirubin total increased].Case narrative: initial information received from united states on 14-jan-2019 regarding an unsolicited valid legal serious case received from a lawyer.This case involves a (b)(6) years old male patient who was treated with hylan g-f 20, sodium hyaluronate (synvisc one) and had gait and station abnormal/unable to walk four blocks without symptoms/unable to walk two flights of stairs without symptoms, acute right otitis media, sinus infection, may be bacterial infection, (latency: unknown) monocytes relative percentage increased (latency: 1 month 1 day), pt low (latency: 1 month 1 day) and bilirubin total increased (latency: 1 month 1 day).Also, a device malfunction was noted in the reported batch number.The patient's past medical history included palpable crepitation with knee flexion-extension, laxity with valgus stress, reduced joint range of motion with forward flexion, external rotation, abduction, positive hawkins, positive jobe's, negative o'brien, tenderness to palpation over the anterior shoulder, abnormal weight loss, abscess, acute ethmoidal sinusitis, denial, nausea, sinus pain, was an eyeglasses wearer, wrist fracture, back surgery on (b)(6) 2015, right knee surgery, influenza immunisation on (b)(6) 2015 and sinal laminectomy.The patient's family history included arthritis with mother, cancer and diabetes mellitus with maternal grandmother, myocardial infarction with grandmother (maternal, paternal), neoplasm malignant with maternal grandfather, cerebral aneurysm with paternal grandfather.Patient was cigar smoker, current some day smoker.Patient had social alcohol use and drinks beer.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing primary localized osteoarthritis of left hip, primary osteoarthritis of right knee/left knee, arthritis of left/right knee (non injury), chronic left shoulder pain, bilateral hip arthritis, multiple joint pain, sulfa drugs allergy (reaction: hives), ivp dye allergy/allergy to contrast media used for diagnostic x-rays (reaction: hives), nickel allergy, abnormal blood sugar, anxiety, chronic lower back pain, chronic pain syndrome, dependent edema, hair loss, headache, hearing loss, herniation of intervertebral disc without myelopathy, hypertension, left atrial dilation, left hip pain, left/right knee pain/bilateral knee pain with palpation, lumbar post-laminectomy syndrome, chronic lumbar radiculopathy, morbid to severe obesity due to excess calories, muscle cramping, neck pain, obstructive sleep apnea on cpap, postoperative wound infection, right shoulder pain, skin sensation disturbance, sore throat, spinal stenosis, phlebitis superficial, tricompartmental disease of knee and umbilical hernia without obstruction and without gangrene and a 2 cm mass palpated in the periumbilical area.Concomitant medications included acetylsalicylic acid (aspirin); diltiazem hydrochloride (diltiazem hcl exte-rel); hydrochlorothiazide, valsartan (valsartan + hidroclorotiazida); doxazosin mesylate; hydrocodone bitartrate, paracetamol (hydrocodone/acetaminophen) for pain; duloxetine hcl; and amoxicillin trihydrate, clavulanate potassium (amoxicillin & clav.Potassium).On (b)(6) 2017, the patient started taking hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 6 ml once (lot - 7rsl021, expiration date: may 2020) in both knees for primary osteoarthritis of right and left knee.On (b)(6) 2017, after latency of 1 month 1 day, patient's blood work showed prothrombin time was 12.0 seconds (low, reference range: 12.1-14.4 seconds), monocytes relative percentage was 13% (high; reference range: 4-12 %), total bilirubin was 1.20 mg/dl (0.20-1.00 mg/dl) and its was suspected that patient may have bacterial infection.On (b)(6) 2017, patient was reported to have acute right otitis media (onset and latency: unknown) and was prescribed azithromycin for the same.On the same day, patient went to health centre for surgical clearance for spinal core stimulator for spinal stenosis to be done on (b)(6) 2017.It was reported that patient had moderate to high risk from cardiovascular standpoint at that time without any additional cardiac testing.Also, patient complained of sinus infection from 1 week) onset date: (b)(6) 2017, latency: unknown) and admitted to pain and facial pressure.Patient's exercise capacity was stated as unable to walk four blocks without symptoms and unable to walk two flights of stairs without symptoms and due to pain and obesity (latency: unknown).Patient had gait and station abnormal and needed cane to ambulate (onset and latency: unknown).Corrective treatment: azithromycin for acute right otitis media; cane for gait and station abnormal/unable to walk four blocks without symptoms/unable to walk two flights of stairs without symptoms; not reported for rest of the events.Outcome: unknown for all events except device malfunction.Seriousness criteria: disability for gait and station abnormal/unable to walk four blocks without symptoms/unable to walk two flights of stairs without symptoms and device malfunction 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.
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