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Contaminated synvisc lot [device malfunction].Hard time walking/instability/ instability up and down stairs [walking difficulty].Possible septic arthritis [septic arthritis] ([knee swelling], [knee pain], [condition aggravated], [fever], [joint range of motion decreased], [stiffness joints], [joint effusion]).Left total knee arthroplasty [knee arthroplasty].Performing heavy and light activities around home [activities of daily living impaired].Chills [chills].Radiation down into her calf [calf pain].Chondromalacia, left knee [chondromalacia].Significant pain [pain].Heart palpitations [palpitation].Weakness [weakness].Decreased appetite [appetite decreased nos].Decreased strength [strength loss of].Case narrative: initial information received on 07-aug-2018 from united states regarding an unsolicited valid serious legal case received from other health professional.This case involves a (b)(6) years old female patient who experienced contaminated synvisc lot, had chills, possible septic arthritis, hard time walking/ instability, radiation down into her calf, chondromalacia, left knee, left knee arthroscopy, significant pain, decreased strength, heart palpitations and weakness, decreased appetite, performing heavy and light activities around home while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Also, device malfunction was identified for the reported lot number.The patient's past medical history included hypertension, gastrooesophageal reflux disease, blood cholesterol increased, sleep apnoea syndrome, chronic obstructive pulmonary disease, tobacco user with former smoker, drug hypersensitivity with morphine cause itching, gastrooesophageal reflux disease and hyperlipidaemia.Concurrent conditions include right and left knee arthroscopy, hiatal hernia, mitral valve prolapse, primary osteoarthritis of left knee.The patient's family history included diabetes mellitus with unknown.The patient's past medical treatment(s), vaccination(s) was not provided.Concomitant medications included benazepril (benazepril); metoprolol (metoprolol); pantoprazole (pantoprazole); indapamide (indapamide); meloxicam (mobic); simvastatin (simvastatin); potassium (potassium); ascorbic acid, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, manganese, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, riboflavin, selenium, thiamine hydrochloride, tocopherol, multivitamin and vitamin b and tramadol (tramadol), ancef (cefradine), zofran, robaxin, percocet, aspirin.On (b)(6) 2017, the patient started taking synvisc one 6 ml 1x intra-articular (lot - 7rsl021) for osteoarthritis.On (b)(6) 2017, patient was administered synvisc one injection from contaminated synvisc lot.On unknown date, patient had to use a walker secondary to pain due to hard time walking/ instability.On unknown date, it was reported that patient had some swelling.On unknown date, patient experienced chills and significant fever.On unknown date, patient experienced significant pain in lateral knee pain posteriorly/pain in left knee/episodes of crunching and instability/severe knee pain which further got increased in the back of her knee and radiation down into her calf.On unknown date, patient also experienced chondromalacia, left knee.Patient also experienced significant pain.She developed heart palpitations.On unknown date, she showed knee stiffness and it was worse since her injection.It was also reported that the aspiration culture was performed/60 cc of blood-tinged cloudy fluid was aspirated from the left knee.On unknown date, patient also experienced weakness.On (b)(6) 2018, the patient complained of left knee pain that has been ongoing for years.However, she recently, two months ago, underwent a left knee arthroscopy with significant debridement and reported that she was not any better and felt still significant pain and instability.She notes that she has swelling and noted it was affecting her normal activities of daily living, and she went to the physician to talk possibly getting a left total knee arthroplasty.On an unknown date, the patient had extreme difficulty performing heavy activities around home and quite a bit difficulty performing light activities.On (b)(6) 2018, patient was admitted and underwent the procedure of left total knee arthroplasty with no complication.Post-op xray revealed prosthesis in good position and alignment patient was given2 grams iv ancefprior to surgery and dose was repeatedx 2 postoperatively and continued daily based and pt/inr values.Patient attended daily physical therapy and by day of discharge was walking> 150 feet with rolling walker.Aquacel knee dressing was changed on post-op day 2, wound was clean and dry, mepilex knee dressing was then applied.Patient was stable for discharge and discharged on (b)(6) 2018.Relevant laboratory test results included: on (b)(6) 2018: basophil count (0.0 - 1.0 %) - 1.1 % [result: 1.1 high], blood creatinine (0.48 - 1.00 mg/dl) result: 1.26 mg/dl.On (b)(6) 2018: blood sodium (136 - 145 mmol/l) 135 mmol/l [result: low], monocyte count (2.7 - 6.6 %) - on (b)(6) 2018: 7.8 % [result: 7.8 high], monocyte count increased (0.2 - 0.5 10*3/ul) - on (b)(6) 2018: 0.6 10*3/ul [result: 0.6 high] and synovial fluid analysis - on (b)(6) 2017: amber [result: amber colored] then cloudy [result: cloudy appearance].On (b)(6) 2018, x-ray- 2 views left knee revealed postop total knee arthroplasty good position and alignment.No evidence of component loosening.Final diagnosis was chondromalacia, left knee, left knee arthroscopy, lateral knee pain posteriorly/pain in left knee/episodes of crunching and instability/severe knee pain, knee stiffness, heart palpitations, significant pain, radiation down into her calf, hard time walking/instability, fever, chills, had some swelling, had to use a walker secondary to pain and contaminated synvisc lot.Corrective treatment: toradol for heart palpitations; dexamethasone and marcaine for aspiration culture was performed/60 cc of blood-tinged cloudy fluid was aspirated; not reported for rest of the events.Outcome: not recovered for hard time walking/instability/ instability up and down stairs.Seriousness criteria: medically significant for possible septic arthritis; disability for hard time walking/instability; intervention required for contaminated synvisc lot, possible septic arthritis; disability, required intervention for device malfunction, left total knee arthroplasty; hospitalization for left total knee arthroplasty.A product technical complaint was initiated on 29-jan-2019 for synvisc-one.Batch number: 7rsl021global 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information received on 23-jan-2019 from a lawyer.Additional event of decreased appetite, performing heavy and light activities around home, decreased strength, symptom of decreased flexion added.Event of aspiration culture was performed/60 cc of blood-tinged cloudy fluid was aspirated, had some swelling, knee stiffness updated to symptom of possible septic arthritis.Medical history added, concomitant medications added.Seriousness criteria updated for events.Clinical course was updated and text amended accordingly.Follow up information was received on 29-jan-2019.No new information received.Follow up information received on 04-feb-2019.Global ptc number added.Text amended accordingly.
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