| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Fatigue (1849); Anxiety (2328); Neck Pain (2433); Neck Stiffness (2434); No Code Available (3191)
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Event Type
Injury
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Event Description
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Infection to the bone [bone infection] ; septic arthritis [septic arthritis] ([gram-positive cocci infection], [knee pain], [joint effusion], [joint inflammation], [joint swelling], [joint warmth]); affected the patient's activities of daily of living [activities of daily living impaired] ; congestion [congestion nasal] ; sinus pressure [sinus pressure] ; fatigue [fatigue] ; cough [cough] ; runny nose [runny nose] ; sneezing [sneezing] ; shortness of breath [shortness of breath] ; wheezing [wheezing] ; gait problem [gait disorder] ; neck stiffness [neck stiffness] ; anxiety [anxiety] ; constant ache that is worse with standing and walking [pain upon movement] ; knee red [injection site joint erythema] ; case narrative: the case is related to case id: (b)(4) (same patient).Initial information received on (b)(6) 2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) female patient who experienced affected the patient's activities of daily of living, infection to the bone, septic arthritis, congestion, sinus pressure, fatigue, cough, shortness of breath, wheezing, gait problem, neck pain, neck stiffness, chest pain, anxiety and constant aching while walking and standing (latency: unknown), while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included gastrooesophageal reflux disease, hyperlipidaemia, pancreatitis, intervertebral disc operation, caesarean section, cholecystectomy, drug hypersensitivity on (b)(6) 2015, neck pain in 1996, mammogram, colonoscopy, irritable bowel syndrome, cholelithiasis, blood cholesterol increased, pneumonia, biliary tract dilation procedure and coronary artery disease.Her past medical treatment included cortisone on (b)(6) 2015.Her past vaccination(s) included hepatitis vaccines, hiv p.E.P., pneumococcal vaccine polysacch 23v, tetanus vaccine and shingrix.Her family history included that her brother experienced cancer, cirrhosis and skin cancer.Her father suffered from cirrhosis, whereas her mother had medical history of hypertension and rheumatoid arthritis.At the time of the event, the patient had ongoing chest pain on (b)(6) 2015, bursitis on (b)(6) 2015, tobacco user with 1.00 pack/day, back pain, hypoaesthesia, paraesthesia, arthritis and menopause.Concomitant medications included amitriptyline hydrochloride (elavil), atorvastatin calcium (lipitor), choline fenofibrate (trilipix), hydrocodone bitartrate, paracetamol (norco), glyceryl trinitrate (nitroglycerine), ondansetron (zofran), tizanidine hydrochloride (zanaflex), ipratropium bromide, salbutamol sulfate (combivent respimat), oxycodone hydrochloride, paracetamol (percocet), promethazine (phenergan), naproxen (naproxen); diazepam (valium) and salbutamol sulfate (proair hfa).On (b)(6) 2016, the patient started using synvisc one injection dosage-6ml via intra-articular route (lot - unk) for bilateral knee pain and primary osteoarthritis of right and left knee.On (b)(6) 2017, patient had knee aspiration where 15 cc of mildly yellow fluid was pulled off due to which she experienced mild effusion.On the same day, analysis of patient's synovial fluid revealed that gram-positive cocci one stain present in it which was in the quantity of 3+.On (b)(6) 2017, patient told that her pain had got worse and had constant aching while walking and standing.On the same date, patient also stated that it had affected the patient's activities of daily of living.On (b)(6) 2017, patient was diagnosed with infection to the bone.On the same day it was observed that patient had a tap of the knee but did show gram-positive cocci one stain but with white count consistent with septic arthritis.On unknown date, patient experienced with congestion and showed sinus pressure.On the unknown date, patient also experienced fatigue which was not recovered.She also presented with cough due which she was also suffered from runny nose and sneezing.On unknown date, she also experienced shortness of breath.She had wheezing.She also stated that she had some gait problem.It was also reported that patient experienced neck stiffness.She was also observed with knee red.On unknown date, she experienced anxiety.On the unknown date, patient experienced knee red and warm to touch.Relevant laboratory test results included: aspiration joint - on (b)(6) 2017: 15 cm3.Blood albumin (3.9 - 4.9 g/l) - on (b)(6) 2017: 3.6 g/l [low].Blood alkaline phosphatase (53 - 141 u/l) - on (b)(6) 2017: 49 u/l [low].Blood pressure measurement (120 - 80 mmhg) - on (b)(6) 2017: 107/70 mmhg.Blood urea (9 - 23 mg/dl) - on (b)(6) 2017: 6 mg/dl [low].Blood urea nitrogen/creatinine ratio (12 - 20 unk) - on (b)(6) 2017: 4.62 unk [low].Culture - on (b)(6) 2017: bone infection unk [bone infection found].Mean cell haemoglobin (27 - 31 pg/cells) - on (b)(6) 2017: 31.70 pg/cells [high].Mean cell volume (80 - 94 fl) - on (b)(6) 2017: 94.50 fl [high].Synovial fluid red blood cells - on (b)(6) 2017: 3353 /ul [high]; on (b)(6) 2017: 6706 /ul [high.] synovial fluid gram stain: on unknown date: 3+.Final diagnosis was anxiety, chest pain, neck stiffness, neck pain, gait problem, wheezing, shortness of breath, cough, fatigue, sinus pressure, congestion, leg swelling, septic arthritis, infection to the bone, affected the patient's activities of daily of living and constant aching while walking and standing the patient was treated with ibuprofen (ibuprofen) for arthralgia, azithromycin (zithromax), clonazepam (klonopin) for anxiety, glyceryl trinitrate (nitroglycerine) for chest pain and prednisone (prednisone) for joint swelling.Outcome: not recovered for congestion, sinus pressure, fatigue, cough, shortness of breath, wheezing, gait problem, neck stiffness; unknown for the rest of the events.Seriousness criteria: medically significant for infection to the bone, intervention required and medically significant for septic arthritis.
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Event Description
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Infection to the bone [bone infection] septic arthritis [septic arthritis] ([joint warmth], [joint inflammation], [joint swelling], [knee pain], [joint effusion], [gram-positive cocci infection]) affected the patient's activities of daily of living [activities of daily living impaired] congestion [congestion nasal] sinus pressure [sinus pressure] fatigue [fatigue] cough [cough] runny nose [runny nose] sneezing [sneezing] shortness of breath [shortness of breath] wheezing [wheezing] gait problem [gait disorder] neck stiffness [neck stiffness] anxiety [anxiety] constant ache that is worse with standing and walking [pain upon movement] knee red [injection site joint erythema] case narrative: the case is related to case id.: (b)(4) (same patient) initial information received on 02-oct-2018 regarding an unsolicited valid serious legal case received from a lawyer.This case involves a 54 years old female patient who experienced affected the patient's activities of daily of living, infection to the bone, septic arthritis, congestion, sinus pressure, fatigue, cough, shortness of breath, wheezing, gait problem, neck pain, neck stiffness, chest pain, anxiety and constant aching while walking and standing (latency: unknown), while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included gastrooesophageal reflux disease, hyperlipidaemia, pancreatitis, intervertebral disc operation, caesarean section, cholecystectomy, drug hypersensitivity on (b)(6) 2015, neck pain in 1996, mammogram, colonoscopy, irritable bowel syndrome, cholelithiasis, blood cholesterol increased, pneumonia, biliary tract dilation procedure and coronary artery disease.Her past medical treatment included cortisone on (b)(6) 2015.Her past vaccination(s) included hepatitis vaccines, hiv p.E.P., pneumococcal vaccine polysacch 23v, tetanus vaccine and shingrix.Her family history included that her brother experienced cancer, cirrhosis and skin cancer.Her father suffered from cirrhosis, whereas her mother had medical history of hypertension and rheumatoid arthritis.At the time of the event, the patient had ongoing chest pain on (b)(6) 2015, bursitis on (b)(6)2015, tobacco user with 1.00 pack/day, back pain, hypoaesthesia, paraesthesia, arthritis and menopause.Concomitant medications included amitriptyline hydrochloride (elavil), atorvastatin calcium (lipitor), choline fenofibrate (trilipix), hydrocodone bitartrate, paracetamol (norco), glyceryl trinitrate (nitroglycerine), ondansetron (zofran), tizanidine hydrochloride (zanaflex), ipratropium bromide, salbutamol sulfate (combivent respimat), oxycodone hydrochloride, paracetamol (percocet), promethazine (phenergan), naproxen (naproxen); diazepam (valium) and salbutamol sulfate (proair hfa).On (b)(6) 2016, the patient started using synvisc one injection dosage-6ml via intra-articular route (lot - unk) for bilateral knee pain and primary osteoarthritis of right and left knee.On (b)(6) 2017, patient had knee aspiration where 15 cc of mildly yellow fluid was pulled off due to which she experienced mild effusion (joint effusion).On the same day, analysis of patient's synovial fluid revealed that gram-positive cocci one stain present in it which was in the quantity of 3+.On (b)(6) 2017, patient told that her pain had got worse and had constant aching while walking and standing (pain).On the same date, patient also stated that it had affected the patient's activities of daily of living (loss of personal independence in daily activities).On (b)(6) 2017, patient was diagnosed with infection to the bone (osteomyelitis).On the same day it was observed that patient had a tap of the knee but did show gram-positive cocci one stain (bacterial infection) but with white count consistent with septic arthritis (arthritis bacterial) had inflammation (arthritis), joint swelling/left knee has started to swell/knee swelling (joint swelling), pain (arthralgia).On unknown date, patient experienced with congestion (nasal congestion) and showed sinus pressure (paranasal sinus discomfort).On the unknown date, patient also experienced fatigue which was not recovered.She also presented with cough due which she was also suffered from runny nose (rhinorrhoea) and sneezing.On unknown date, she also experienced shortness of breath (dyspnoea).She had wheezing.She also stated that she had some gait problem (gait disturbance).It was also reported that patient experienced neck stiffness (musculoskeletal stiffness).She was also observed with knee red (injection site joint erythema).On unknown date, she experienced anxiety.On the unknown date, patient experienced knee red and warm to touch (joint warmth).Relevant laboratory test results included: aspiration joint - on (b)(6) 2017: 15 cm3.Blood albumin (3.9 - 4.9 g/l) - on 01-apr-2017: 3.6 g/l [low].Blood alkaline phosphatase (53 - 141 u/l) - on (b)(6) 2017: 49 u/l [low].Blood pressure measurement (120 - 80 mmhg) - on (b)(6) 2017: 107/70 mmhg.Blood urea (9 - 23 mg/dl) - on 01-apr-2017: 6 mg/dl [low].Blood urea nitrogen/creatinine ratio (12 - 20 unk) - on (b)(6) 2017: 4.62 unk [low].Culture - on (b)(6) 2017: bone infection unk [bone infection found].Mean cell haemoglobin (27 - 31 pg/cells) - on (b)(6) 2017: 31.70 pg/cells [high].Mean cell volume (80 - 94 fl) - on (b)(6) 2017: 94.50 fl [high].Synovial fluid red blood cells - on (b)(6) 2017: 3353 /ul [high]; on (b)(6) 2017: 6706 /ul [high] synovial fluid gram stain: on unknown date: 3+.Final diagnosis was anxiety, chest pain, neck stiffness, neck pain, gait problem, wheezing, shortness of breath, cough, fatigue, sinus pressure, congestion, leg swelling, septic arthritis, infection to the bone, affected the patient's activities of daily of living and constant aching while walking and standing action taken: not applicable for all events the patient was treated with ibuprofen (ibuprofen) for arthralgia, azithromycin (zithromax), clonazepam (klonopin) for anxiety, glyceryl trinitrate (nitroglycerine) for chest pain and prednisone (prednisone) for joint swelling.Outcome: not recovered for congestion, sinus pressure, fatigue, cough, shortness of breath, wheezing, gait problem, neck stiffness; unknown for the rest of the events.A product technical complaint (ptc) was initiated on 02-oct-2018 for synvisc one, batch number: unknown with global ptc number: 100124642.The product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation was completed on 14-may-2021.Seriousness criteria: medically significant for infection to the bone, intervention required and medically significant for septic arthritis, disability for activities of daily living impaired.Follow up information received on 02-may-2018 from healthcare professional.Global ptc number was added.Additional information was received on 14-may-2021 from healthcare professional.Ptc results were added.
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