| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Fatigue (1849); Fever (1858); Muscle Spasm(s) (1966); Pain (1994); Rash (2033); Swelling (2091); Anxiety (2328); Arthralgia (2355); Joint Swelling (2356); Malaise (2359); Depression (2361); Reaction, Injection Site (2442); Sleep Dysfunction (2517); No Code Available (3191)
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| Event Date 12/01/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on (b)(6) 2017 from the patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few days patient can hardly walk/couldn't get around, it was huge out in front of the knee now/it swelled, site was sore, like a bruise, fever on and off/felt like she had a fever that would come and go, having pain everywhere, felt sick, flu, lethargic, could not bend it, muscles were sore around the area, feels like the knee was going forward and back and was afraid she might fall, it was very painful and different than before the injection/injection site was painful/lots of pain.No concurrent condition was reported.Past medication included synvisc (3 injections in the knee; years ago) and cortisone injection (last year or early this year).Relevant medical history had repair of torn meniscus ((b)(6) 2017), tkr in the right knee (2008).It was reported that both the knees were bone on bone.Patient was not allergic to avian proteins, feathers, or egg products.Prior to the injection, the patient could stand and walk.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (indication, lot number and expiration date: not reported) in the left knee.Patient did not engage in activities such as jogging or tennis soon after the injection.Immediately following the injection, she could move around as normal.On an unknown date in (b)(6) 2017, few days after initiating treatment, it was very painful and different than before the injection.Few days later the site was sore, like a bruise.Patient stated that when the fluid goes in, it goes in like a bunch and she was still mobile then.It was huge out in front of the knee now.The weekend following the injection, she felt like she had a fever that would come and go (latency: few days).Patient took paracetamol ((b)(6)) for it.Patient was having pain everywhere and the injection was supposed to help her (latency: few days).Patient had not felt such pain except after the right knee replacement (in 2008).By day 5 or 6, patient felt sick (latency: few days).Patient had the flu, feeling more lethargic (latency: few days) and patient rested a lot.On day 9, it swelled and day 10, patient could not bend it and couldn't get around and day 11, patient couldn't bend it and was in lots of pain (latency: few days).It was reported that the muscles were sore around the area and she was on crutches due to the swelling (latency: few days).Patient said it felt like the knee was going forward and back and was afraid she might fall.Patient tried tried a knee brace, but took it off due to the swelling.The surgeon said he was not in until (b)(6) 2017 and to go to the er.Patient took 2 celecoxib a day before, but the physician told the patient to take one now.Patient took 2 paracetamol to help with the pain.Patient iced and elevated the knee as well.On (b)(6) 2017, the patient could hardly walk and had to use crutches.Patient took a taxi to emergency room (er).Patient was running a fever on and off and took paracetamol rested and drank plenty of fluids.Reportedly, the patient was not hospitalized.Corrective treatment: using crutches for can hardly walk/couldn't get around, crutches, iced and elevated the knee for it was huge out in front of the knee now/it swelled; iced the knee, celecoxib (celebrex), paracetamol for site was sore, like a bruise and it was very painful and different than before the injection/injection site was painful/lots of pain; paracetamol (tylenol), rested, and drank plenty of fluids for fever on and off/felt like she had a fever that would come and go; paracetamol for having pain everywhere, felt sick, flu, muscles were sore around the area; rested for lethargic; knee brace for feels like the knee was going forward and back and was afraid she might fall; not reported for could not bend it outcome: not recovered for all a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: disability for can hardly walk/couldn't get around, it was huge out in front of the knee now/it swelled pharmacovigilance comment: sanofi company comment dated 21-dec-2017: this case concerns a patient who has received synvisc one injection for an unknown indication and can hardly walk/couldn't get around.The event is temporally related to device and therefore causal relationship with device cannot be ruled out completely.However, patient's medical history and underlying condition might also be a contributing factor for the occurrence of event.
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Event Description
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This unsolicited case from united states was received on 14-dec-2017 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after few days patient can hardly walk/couldn't get around/ not being mobile, it was huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up, site was sore, like a bruise, fever on and off/felt like she had a fever that would come and go, having pain everywhere, felt sick, flu, lethargic, could not bend it/ can't bend her leg, muscles were sore around the area, feels like the knee was going forward and back and was afraid she might fall, it was very painful and different than before the injection/injection site was painful/lots of pain/ acute pain in left knee, drained my knee/experiencing fluid build up/leg still fills up with fluid and can't function for myself or to take care of my daughter.No concurrent condition was reported.Past medication included synvisc (3 injections in the knee; years ago) and cortisone injection (last year or early this year).Relevant medical history had repair of torn meniscus ((b)(6) 2017), tkr in the right knee (2008).It was reported that both the knees were bone on bone.Patient was not allergic to avian proteins, feathers, or egg products.Prior to the injection, the patient could stand and walk.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (indication, lot number and expiration date: not reported) in the left knee.Patient did not engage in activities such as jogging or tennis soon after the injection.Immediately following the injection, she could move around as normal.On an unknown date in (b)(6) 2017, few days after initiating treatment, it was very painful and different than before the injection.Few days later the site was sore, like a bruise.Patient stated that when the fluid goes in, it goes in like a bunch and she was still mobile then.It was huge out in front of the knee now.The weekend following the injection, she felt like she had a fever that would come and go (latency: few days).Patient took paracetamol (tylenol) for it.Patient was having pain everywhere and the injection was supposed to help her (latency: few days).Patient had not felt such pain except after the right knee replacement (in 2008).By day 5 or 6, patient felt sick (latency: few days).Patient had the flu, feeling more lethargic (latency: few days) and patient rested a lot.On day 9, it swelled and day 10, patient could not bend it and couldn't get around and day 11, patient couldn't bend it and was in lots of pain (latency: few days).It was reported that the muscles were sore around the area and she was on crutches due to the swelling (latency: few days).Patient said it felt like the knee was going forward and back and was afraid she might fall.Patient tried tried a knee brace, but took it off due to the swelling.The surgeon said he was not in until (b)(6)-2017 and to go to the er.Patient took 2 celecoxib a day before, but the physician told the patient to take one now.Patient took 2 paracetamol to help with the pain.Patient iced and elevated the knee as well.On (b)(6) 2017, the patient could hardly walk and had to use crutches.Patient took a taxi to emergency room (er).Patient was running a fever on and off and took paracetamol rested and drank plenty of fluids.Reportedly, the patient was not hospitalized.Patient stated that everyday knee swells up so big and so painful.She was on crutches.I could not stand the pain.She had to elevate and ice.It did't go away.It just kept swelling.She was going to go back the er to get more fluid taken off (onset: (b)(6) 2017; latency: few days).It was so painful that the patient was in tears.She couldn't function for herself or take care of her daughter (onset: (b)(6) 2017; latency: few days).She said her knee kept swelling up and was so painful.Corrective treatment: using crutches for can hardly walk/couldn't get around/not being mobile, crutches, iced and elevated the knee for it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; iced the knee, celecoxib (celebrex), paracetamol for site was sore, like a bruise and it was very painful and different than before the injection/injection site was painful/lots of pain; paracetamol (tylenol), rested, and drank plenty of fluids for fever on and off/felt like she had a fever that would come and go; paracetamol for having pain everywhere, felt sick, flu, muscles were sore around the area; rested for lethargic; knee brace for feels like the knee was going forward and back and was afraid she might fall; not reported for rest outcome: unknown for can't function for myself or to take care of my daughter; not recovered for rest a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: disability for can hardly walk/couldn't get around, it was huge out in front of the knee now/it swelled additional information was received on 18-dec-2017 and 21-dec-2017 (processed with clock start date of 18-dec- 2017) from the patient.Event of can't function for myself or to take care of my daughter and drained my knee/experiencing fluid build up/leg still fills up with fluid was added.Event of can hardly walk/couldn't get around was updated to can hardly walk/couldn't get around/not being mobile; it is huge out in front of the knee now/it swelled/it swells up so big was updated to it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; event of could not bend it was updated to could not bend it/ can't bend her leg; event of it was very painful and different than before the injection/injection site was painful/lots of pain was updated to it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 18-dec-2017: follow up information received does not changes previous case assessment.This case concerns a patient who has received synvisc one injection for an unknown indication and can hardly walk/couldn't get around.The event is temporally related to device and therefore causal relationship with device cannot be ruled out completely.However, patient's medical history and underlying condition might also be a contributing factor for the occurrence of event.
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Event Description
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This unsolicited case from united states was received on 14-dec-2017 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after few days patient can hardly walk/couldn't get around/ not being mobile, it was huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up, site was sore, like a bruise, fever on and off/felt like she had a fever that would come and go, having pain everywhere, felt sick, flu, lethargic, could not bend it/ can't bend her leg, muscles were sore around the area, feels like the knee was going forward and back and was afraid she might fall, it was very painful and different than before the injection/injection site was painful/lots of pain/ acute pain in left knee, drained my knee/experiencing fluid build up/leg still fills up with fluid and can't function for myself or to take care of my daughter.No concurrent condition was reported.Past medication included synvisc (3 injections in the knee; years ago) and cortisone injection (last year or early this year).Relevant medical history had repair of torn meniscus ((b)(6) 2017), tkr in the right knee (2008).It was reported that both the knees were bone on bone.Patient was not allergic to avian proteins, feathers, or egg products.Prior to the injection, the patient could stand and walk.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (indication, lot number and expiration date: not reported) in the left knee.Patient did not engage in activities such as jogging or tennis soon after the injection.Immediately following the injection, she could move around as normal.On an unknown date in (b)(6) 2017, few days after initiating treatment, it was very painful and different than before the injection.Few days later the site was sore, like a bruise.Patient stated that when the fluid goes in, it goes in like a bunch and she was still mobile then.It was huge out in front of the knee now.The weekend following the injection, she felt like she had a fever that would come and go (latency: few days).Patient took paracetamol (tylenol) for it.Patient was having pain everywhere and the injection was supposed to help her (latency: few days).Patient had not felt such pain except after the right knee replacement (in 2008).By day 5 or 6, patient felt sick (latency: few days).Patient had the flu, feeling more lethargic (latency: few days) and patient rested a lot.On day 9, it swelled and day 10, patient could not bend it and couldn't get around and day 11, patient couldn't bend it and was in lots of pain (latency: few days).It was reported that the muscles were sore around the area and she was on crutches due to the swelling (latency: few days).Patient said it felt like the knee was going forward and back and was afraid she might fall.Patient tried tried a knee brace, but took it off due to the swelling.The surgeon said he was not in until (b)(6) 2017 and to go to the er.Patient took 2 celecoxib a day before, but the physician told the patient to take one now.Patient took 2 paracetamol to help with the pain.Patient iced and elevated the knee as well.On (b)(6) 2017, the patient could hardly walk and had to use crutches.Patient took a taxi to emergency room (er).Patient was running a fever on and off and took paracetamol rested and drank plenty of fluids.Reportedly, the patient was not hospitalized.Patient stated that everyday knee swells up so big and so painful.She was on crutches.I could not stand the pain.She had to elevate and ice.It did't go away.It just kept swelling.She was going to go back the er to get more fluid taken off (onset: (b)(6) 2017; latency: few days).It was so painful that the patient was in tears.She couldn't function for herself or take care of her daughter (onset: (b)(6) 2017; latency: few days).She said her knee kept swelling up and was so painful.Corrective treatment: using crutches for can hardly walk/couldn't get around/not being mobile, crutches, iced and elevated the knee for it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; iced the knee, celecoxib (celebrex), paracetamol for site was sore, like a bruise and it was very painful and different than before the injection/injection site was painful/lots of pain; paracetamol (tylenol), rested, and drank plenty of fluids for fever on and off/felt like she had a fever that would come and go; paracetamol for having pain everywhere, felt sick, flu, muscles were sore around the area; rested for lethargic; knee brace for feels like the knee was going forward and back and was afraid she might fall; not reported for rest outcome: unknown for can't function for myself or to take care of my daughter; not recovered for rest a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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 would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for can hardly walk/couldn't get around, it was huge out in front of the knee now/it swelled additional information was received on 18-dec-2017 and 21-dec-2017 (processed with clock start date of 18-dec- 2017) from the patient.Event of can't function for myself or to take care of my daughter and drained my knee/experiencing fluid build up/leg still fills up with fluid was added.Event of can hardly walk/couldn't get around was updated to can hardly walk/couldn't get around/not being mobile; it is huge out in front of the knee now/it swelled/it swells up so big was updated to it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; event of could not bend it was updated to could not bend it/ can't bend her leg; event of it was very painful and different than before the injection/injection site was painful/lots of pain was updated to it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee.Clinical course was updated and text amended accordingly.Follow up information was received on 12-jan-2018.No new information received additional information was received on 23-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 23-jan-2017: follow up information received does not change previous case assessment.This case concerns a patient who has received synvisc one injection for an unknown indication and can hardly walk/couldn't get around.The event is temporally related to device and therefore causal relationship with device cannot be ruled out completely.However, patient's medical history and underlying condition might also be a contributing factor for the occurrence of event.
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Event Description
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This unsolicited case from united states was received on 14-dec-2017 from the patient.This case concerns a 51 year old female patient who received treatment with synvisc one injection and after few days patient can hardly walk/couldn't get around/ not being mobile, it was huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up, site was sore, like a bruise, fever on and off/felt like she had a fever that would come and go, having pain everywhere, felt sick, flu, lethargic, could not bend it/ can't bend her leg, muscles were sore around the area, feels like the knee was going forward and back and was afraid she might fall, it was very painful and different than before the injection/injection site was painful/lots of pain/ acute pain in left knee, drained my knee/experiencing fluid build up/leg still fills up with fluid and can't function for myself or to take care of my daughter.No concurrent condition was reported.Past medication included synvisc (3 injections in the knee; years ago) and cortisone injection (last year or early this year).Relevant medical history had repair of torn meniscus ((b)(6) 2017), tkr in the right knee (2008).It was reported that both the knees were bone on bone.Patient was not allergic to avian proteins, feathers, or egg products.Prior to the injection, the patient could stand and walk.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (indication, lot number and expiration date: not reported) in the left knee.Patient did not engage in activities such as jogging or tennis soon after the injection.Immediately following the injection, she could move around as normal.On an unknown date in (b)(6) 2017, few days after initiating treatment, it was very painful and different than before the injection.Few days later the site was sore, like a bruise.Patient stated that when the fluid goes in, it goes in like a bunch and she was still mobile then.It was huge out in front of the knee now.The weekend following the injection, she felt like she had a fever that would come and go (latency: few days).Patient took paracetamol (tylenol) for it.Patient was having pain everywhere and the injection was supposed to help her (latency: few days).Patient had not felt such pain except after the right knee replacement (in 2008).By day 5 or 6, patient felt sick (latency: few days).Patient had the flu, feeling more lethargic (latency: few days) and patient rested a lot.On day 9, it swelled and day 10, patient could not bend it and couldn't get around and day 11, patient couldn't bend it and was in lots of pain (latency: few days).It was reported that the muscles were sore around the area and she was on crutches due to the swelling (latency: few days).Patient said it felt like the knee was going forward and back and was afraid she might fall.Patient tried a knee brace, but took it off due to the swelling.The surgeon said he was not in until (b)(6) 2017 and to go to the er.Patient took 2 celecoxib a day before, but the physician told the patient to take one now.Patient took 2 paracetamol to help with the pain.Patient iced and elevated the knee as well.On (b)(6) 2017, the patient could hardly walk and had to use crutches.Patient took a taxi to emergency room (er).Patient was running a fever on and off and took paracetamol rested and drank plenty of fluids.Reportedly, the patient was not hospitalized.Patient stated that everyday knee swells up so big and so painful.She was on crutches.I could not stand the pain.She had to elevate and ice.It did't go away.It just kept swelling.She was going to go back the er to get more fluid taken off (onset: (b)(6) 2017; latency: few days).It was so painful that the patient was in tears.She couldn't function for herself or take care of her daughter (onset: (b)(6) 2017; latency: few days).She said her knee kept swelling up and was so painful.Information received on (b)(6) 2018 that patient have severe pain and was still suffering.It was reported that patient had contaminated lot, was drained 3 times but her tests did not show contamination.Corrective treatment: using crutches for can hardly walk/couldn't get around/not being mobile, crutches, iced and elevated the knee for it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; iced the knee, celecoxib (celebrex), paracetamol for site was sore, like a bruise and it was very painful and different than before the injection/injection site was painful/lots of pain; paracetamol (tylenol), rested, and drank plenty of fluids for fever on and off/felt like she had a fever that would come and go; paracetamol for having pain everywhere, felt sick, flu, muscles were sore around the area; rested for lethargic; knee brace for feels like the knee was going forward and back and was afraid she might fall; not reported for rest outcome: unknown for can't function for myself or to take care of my daughter; not recovered for rest a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51310 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 would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for can hardly walk/couldn't get around, it was huge out in front of the knee now/it swelled additional information was received on 18-dec-2017 and 21-dec-2017 (processed with clock start date of (b)(6) 2017) from the patient.Event of can't function for myself or to take care of my daughter and drained my knee/experiencing fluid build up/leg still fills up with fluid was added.Event of can hardly walk/couldn't get around was updated to can hardly walk/couldn't get around/not being mobile; it is huge out in front of the knee now/it swelled/it swells up so big was updated to it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; event of could not bend it was updated to could not bend it/ can't bend her leg; event of it was very painful and different than before the injection/injection site was painful/lots of pain was updated to it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee.Clinical course was updated and text amended accordingly.Follow up information was received on 12-jan-2018.No new information received additional information was received on 23-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 23-apr-2018.Clinical course updated.Pharmacovigilance comment: sanofi company comment for follow up dated 23-apr-2017: follow up information received does not change previous case assessment.This case concerns a patient who has received synvisc one injection for an unknown indication and can hardly walk/couldn't get around.The event is temporally related to device and therefore causal relationship with device cannot be ruled out completely.However, patient's medical history and underlying condition might also be a contributing factor for the occurrence of event.
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Event Description
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Can hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp [difficulty in walking], unable to bear weight [weight bearing difficulty], it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up [swelling of l knee], it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee/ left knee pain/ tenderness/ pain in right knee [knee pain] ([pain aggravated]), fever on and off/felt like she had a fever that would come and go [fever] , having pain everywhere [general body pain], felt sick [feeling sick], flu [flu], lethargic [lethargic], could not bend it/ can't bend her leg/ limited rom per pt [joint range of motion decreased], muscles are sore around the area/ muscle pain [muscle pain], feels like the knee is going forward and back and is afraid she might fall [feeling abnormal], can't function for myself or to take care of my daughter [activities of daily living impaired], leg swelling [swelling of legs], hypercholesterolemia [hypercholesterolemia] , prediabetes [prediabetes], acute bronchitis, unspecified organism [acute bronchitis] ([cough], [ear pain], [sinus pain], [sore throat], [sinus congestion],), painful walking [pain upon movement] , crepitus [crepitations] , pain in her knee, back and shoulders [back pain], pain in her knee, back and shoulders [shoulder pain], chronic left lateral breast tenderness [breast tenderness], red papulovesicular rash [papulovesicular rash] , dysuria [dysuria], tension headache [tension headache] , depressed [depressed state], fatigue [fatigue], difficulty sleeping [difficulty sleeping] , cramps [cramps], anxiety [anxiety], drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid [effusion (l) knee], allergic reaction [allergic reaction] ([swelling]), and site was sore, like a bruise/ bruising [injection site bruising].Case narrative: this unsolicited legal case from united states was received on 14-dec-2017 from the patient.This case concerns a 51 year old female patient who received treatment with synvisc one injection and after days patient hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp, it was huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up, site was sore, like a bruise, fever on and off/felt like she had a fever that would come and go, having pain everywhere, felt sick, flu, lethargic, could not bend it/ can't bend her leg/ limited rom per pt, muscles are sore around the area/ muscle pain, feels like the knee was going forward and back and was afraid she might fall, it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee/ left knee pain/ tenderness/ pain in right knee, drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid, can't function for myself or to take care of my daughter, unable to bear weight, leg swelling, hypercholesterolemia, prediabetes, acute bronchitis, unspecified organism, painful walking, crepitus, pain in her knee, back and shoulders, chronic left lateral breast tenderness, red papulovesicular rash, dysuria, tension headache, depressed, fatigue, difficulty sleeping, cramps, anxiety, allergic reaction.Past medication included synvisc (3 injections in the knee; years ago), cortisone injection (last year or early this year) and kenalog (10 months ago).Relevant medical history had repair of torn meniscus ((b)(6) 2017), tkr in the right knee (2008), knee arthroscopy ((b)(6) 2017).It was reported that both the knees were bone on bone.Patient was not allergic to avian proteins, feathers, or egg products.Prior to the injection, the patient could stand and walk.Her past medical history included meniscus pain, endometrial ablation, wisdom tooth extraction, pharyngitis, upper respiratory infection, swelling, itchy rash eyelids.Patient's concurrent conditions included neck strain, chronic pain, left breast mass, allergic rhinitis, thyroid nodule, overweight, perimenopausal vasomotor symptoms, eyelid dermatitis, grief, left knee pain, stiffness, left knee medial meniscus tear, chondromalacia, alcohol user, back problem, chronic back pain and lipoma of torso.She had vaccine of tdap, zostavax, prevnar, pneumovax and influenza, injectable, quadrivalent, preservative free.She had mammogram ((b)(6) 2016) and colonoscopy.Her family history include that her step father died because of stroke.Her father had history of diabetes, depression, stomach cancer and alcoholism.Her mother had medical history of macular degen, cataract, glaucoma, ddd, scoliosis and breast cancer.Her brother had medical history of high cholesterol, aortic aneurism, hypertension and alcohol/ drug use.Her other family member had history of hypertension.Her concomitant medication included triamcinolone acetonide (kenalog); cetirizine hydrochloride (zyrtec), fexofenadine hydrochloride (allegra), celecoxib (celebrex), cyclobenzaprine hydrochloride (flexeril) fluticasone propionate (flonase), calcium, colecalciferol (calcium + d3), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (centrum silver adults 50+), ondansetron (zofran), midazolam hydrochloride (versed), calcium chloride, potassium chloride, sodium lactate (lactated ringers), fentanyl (sublimaze ), propofol (diprivan); lidocaine (xylocaine), ephedrine (ephedrine), dexamethasone sodium phosphate (decadron), macrogol, potassium chloride, sodium bicarbonate (nulytely), valaciclovir hydrochloride (valtrex), hydromorphone hydrochloride (dilaudid), prochlorperazine maleate (compazine), sodium chloride (sodium chloride 0.9%), iopamidol (isovue 300), paracetamol (tylenol), azithromycin (zithromax), ibuprofen (ibuprofen), diphenhydramine hydrochloride, pseudoephedrine hydrochloride (sudafed), hydrocodone bitartrate, paracetamol (vicodin), bupropion hydrochloride (wellbutrin), duloxetine hydrochloride (cymbalta), hydrocodone bitartrate, paracetamol (norco), esomeprazole magnesium (nexium), metaxalone and gabapentin.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once for end-stage arthritis of the knee (lot number and expiration date: not reported) in the left knee.Patient did not engage in activities such as jogging or tennis soon after the injection.Immediately following the injection, she could move around as normal.On an unknown date in (b)(6) 2017, few days after initiating treatment, it was very painful and different than before the injection.Few days later the site was sore, like a bruise.Patient stated that when the fluid goes in, it goes in like a bunch and she was still mobile then.It was huge out in front of the knee now.The weekend following the injection, she felt like she had a fever that would come and go (latency: few days).Patient took paracetamol (tylenol) for it.Patient was having pain everywhere and the injection was supposed to help her (latency: few days).Patient had not felt such pain except after the right knee replacement (in 2008).By day 5 or 6, patient felt sick (latency: few days).Patient had the flu, feeling more lethargic (latency: few days) and patient rested a lot.On day 9, it swelled and day 10, patient could not bend it and couldn't get around and day 11, patient couldn't bend it and was in lots of pain (latency: few days).It was reported that the muscles were sore around the area and she was on crutches due to the swelling (latency: few days).Patient said it felt like the knee was going forward and back and was afraid she might fall.Patient tried tried a knee brace, but took it off due to the swelling.On the evaluation of (b)(6) 2017, it was observed that patient presented with left knee pain status post injection.Injection was given two weeks ago, pain was started one week ago.It was sharp, severe, diffuse, constant, worse with movement.Some swelling and bruising was also observed and had recent fever.On same day, patient had lab of arthrocentesis and 30 cc of fluid was extracted.The surgeon said he was not in until (b)(6) 2017 and to go to the er.Patient took 2 celecoxib a day before, but the physician told the patient to take one now.Patient took 2 paracetamol to help with the pain.Patient iced and elevated the knee as well.On (b)(6) 2017, the patient could hardly walk and had to use crutches.On the same day, during lab analysis the appearance of synovial fluid was cloudy.Patient took a taxi to emergency room (er).Patient was running a fever on and off and took paracetamol rested and drank plenty of fluids.Reportedly, the patient was not hospitalized.Patient stated that everyday knee swells up so big and so painful.She was on crutches.I could not stand the pain.She had to elevate and ice.It did't go away.It just kept swelling.She was going to go back the er to get more fluid taken off (onset: (b)(6) 2017; latency: few days).It was so painful that the patient was in tears.She couldn't function for herself or take care of her daughter (onset: (b)(6) 2017; latency: few days).On (b)(6) 2017, patient underwent medical evaluation and it was reported that patient had leg swelling, arthralgia, gait problem and joint swelling.It was also reported that patient had decreased range of motion, swelling and effusion.On (b)(6) 2017, she again underwent in the lab of arthrocentesis and 65 cc of fluid was extracted.She said her knee kept swelling up and was so painful.On (b)(6) 2017, patient underwent lab analysis and it was observed that platelet count was 472 10e3/ul (high), potassium was 5.5 meq/l (high), ldl-chol, direct was 159 mg/dl (high).On (b)(6) 2018, she went lab analysis and it was observed that cholesterol was 268 mg/dl (high), triglyceride was 220 mg/dl (high), ldl was 165 optimal mg/dl (high) and non-hdl cholesterol was 209 optimal mg/dl (high), potassium was 5.5 meq/l (high) and glucose was 107 mg/dl (high).On (b)(6) 2018, patient was suffering from cough, cough keeping patient awake at night, post nasal drip, sinus congestion and sore throat.On the medical evaluation of (b)(6) 2018, it was observed that patient was diagnosed with acute bronchitis, unspecified organism.It was observed that patient was suffering prediabetes and hypercholesterolemia.Information received on (b)(6) 2018 that patient have severe pain and was still suffering.It was reported that patient had contaminated lot, was drained 3 times but her tests did not show contamination.On the medical evaluation of (b)(6) 2018, patient experienced other acute postprocedural pain.It was also reported that patient continued to have some problem with left knee, which got worse recently, seen at urgent care due to pain and swelling.On (b)(6) 2018, patient underwent lab analysis and it was observed that glucose was 100 mg/dl (high).Potassium was 5.2 mmol/l (high).On the same day, during mri examination it was observed that patient was having moderate to severe chondromalacia of the triarticular surfaces, not bone to bone.It was also reported that patient refused to have synvisc one injection since in past she had severe reaction.She was having lot of pain.She requested for total knee arthroplasty.On the evaluation (b)(6) 2018, it was reported that she was very active previously, but experienced setbacks and decreased activity when she started having knee problems then surgery in 2008.Still experiences significant pain in her right knee (tkr 2008), left knee scope in 2017, waiting to find out if she will have surgery on that knee.She also experienced pain in her lower back/hips and shoulders.On the evaluation of (b)(6) 2018, it was reported that patient was still suffering for significant pain in her knee, back and shoulders.She stated that she felt trapped by the pain she suffers, not able to leave the house on some days because the pain was so debilitating.She could stand upright or in certain positions for too long.Also noted that the patient had not been able to work, and she admitted that money was tight.She became tearful while talking about her pain and how it was interfering with her life.On (b)(6) 2018, during examination she was observed with chronic left lateral breast tenderness, red papulovesicular rash on inflamed base bilat axilla and was wearing left knee brace.On the evaluation of (b)(6) 2018, patient complained of acute on chronic back pain and right shoulder pain.On (b)(6) 2019, it was reported that for the treatment of end stage arthritis of the knee, it was suggested that patient should undergo total knee arthroplasty (replacement).Physician recommended total knee arthroplasty but she wanted second opinion.She has had injections in the past but had synvisc but states this caused severe pain afterwards.Now she felt she could no longer tolerate knee pain and wanted surgery.She was being managed by physician who did a knee arthroscopy and reported full-thickness, stage 4 chondromalacia throughout her knee.Follow-up recommendation was that she had total knee arthroplasty as well.She has had total knee arthroplasty on her right with great success.She felt that the pain and dysfunction caused by her knee were severely affecting her life.On the unknown date, she also reported to had fatigue, dysuria, anxiety, cramps and tension headaches.Corrective treatment: using crutches for can hardly walk/couldn't get around/not being mobile, crutches, iced and elevated the knee for it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; iced the knee, celecoxib (celebrex), paracetamol for site was sore, like a bruise and it was very painful and different than before the injection/injection site was painful/lots of pain; paracetamol (tylenol), rested, and drank plenty of fluids for fever on and off/felt like she had a fever that would come and go; paracetamol for having pain everywhere, felt sick, flu, muscles were sore around the area; rested for lethargic; knee brace for feels like the knee was going forward and back and was afraid she might fall; not reported for rest outcome: unknown for can't function for myself or to take care of my daughter, total knee arthroplasty (replacement), unable to bear weight, leg swelling, hypercholesterolemia, prediabetes, acute bronchitis, unspecified organism, painful walking, crepitus, pain in her knee, back and shoulders, chronic left lateral breast tenderness, red papulovesicular rash, dysuria, tension headache, depressed, fatigue, difficulty sleeping, cramps and anxiety; recovered for drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid; not recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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 would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp, unable to bear weight, it was huge out in front of the knee now/it swelled; intervention required for knee pain and joint swelling additional information was received on 18-dec-2017 and 21-dec-2017 (processed with clock start date of 18-dec-2017) from the patient.Event of can't function for myself or to take care of my daughter and drained my knee/experiencing fluid build up/leg still fills up with fluid was added.Event of can hardly walk/couldn't get around was updated to can hardly walk/couldn't get around/not being mobile; it is huge out in front of the knee now/it swelled/it swells up so big was updated to it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; event of could not bend it was updated to could not bend it/ can't bend her leg; event of it was very painful and different than before the injection/injection site was painful/lots of pain was updated to it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee.Clinical course was updated and text amended accordingly.Follow up information was received on 12-jan-2018.No new information received.Additional information was received on 23-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 23-apr-2018.Clinical course updated.Additional information was received on 21-may-2019 from the lawyer.Case has been updated to legal case.Concomitant medications were added.Her medical history was added.Additional events of total knee arthroplasty (replacement), unable to bear weight, leg swelling, hypercholesterolemia, prediabetes, painful walking, acute bronchitis, unspecified organism, crepitus, pain in her knee, back and shoulders, chronic left lateral breast tenderness, red papulovesicular rash, dysuria, tension headache, depressed, fatigue, difficulty sleeping, cramps and anxiety.Verbatim for can hardly walk/couldn't get around/not being mobile was updated to can hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp.Verbatim for could not bend it/ can't bend her leg was updated to could not bend it/ can't bend her leg/ limited rom per pt.Verbatim for muscles are sore around the area was updated muscles are sore around the area/ muscle pain.Verbatim for it was very painful and different than before the injection/injection site was painful/lots of pain/ acute pain in left knee was updated to it was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee/ left knee pain/ tenderness/ pain in right knee.Verbatim for drained my knee/experiencing fluid build up/leg still fills up with fluid was updated to drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid.Clinical course updated and text amended accordingly.
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Event Description
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Unable to bear weight [weight bearing difficulty].Can hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp [difficulty in walking].It is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up [swelling of l knee].It was very painful and different than before the injection/injection site was painful/lots of pain/acute pain in left knee/ left knee pain/ tenderness/ pain in right knee [knee pain] ([pain aggravated]).Having pain everywhere [general body pain].Flu [flu].Lethargic [lethargic].Could not bend it/ can't bend her leg/ limited rom per pt [joint range of motion decreased].Muscles are sore around the area/ muscle pain [muscle pain].Feels like the knee is going forward and back and is afraid she might fall [feeling abnormal].Can't function for myself or to take care of my daughter [activities of daily living impaired] hypercholesterolemia [hypercholesterolemia].Prediabetes [prediabetes].Acute bronchitis, unspecified organism [acute bronchitis] ([ear pain], [sinus pain], [sore throat], [sinus congestion], [cough]).Painful walking [pain upon movement].Crepitus [crepitations].Pain in her knee, back and shoulders [back pain].Pain in her knee, back and shoulders [shoulder pain].Chronic left lateral breast tenderness [breast tenderness].Dysuria [dysuria].Tension headache [tension headache].Depressed [depressed state].Difficulty sleeping [difficulty sleeping].Cramps [cramps].Anxiety/ anxious [anxiety].Insomnia [insomnia].Depressed [depressed mood].Heightened irritability [irritability].Negative thinking [negative thoughts].Moments of despair [feeling of despair].Leg swelling [swelling of legs].Fever on and off/felt like she had a fever that would come and go [fever].Red papulovesicular rash [papulovesicular rash].Felt sick [feeling sick].Fatigue [fatigue].Allergic reaction [allergic reaction] ([swelling]).Drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid [effusion (l) knee].Site was sore, like a bruise/ bruising [injection site bruising].Case narrative: this unsolicited valid serious legal case from united states was received on (b)(6) 2017 from the patient (pt).This case concerns a 51 year old female pt who received treatment with synvisc one injection (inj) and after days pt hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp, it was huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up, site was sore, like a bruise, fever on and off/felt like she had a fever that would come and go, having pain everywhere, felt sick, flu, lethargic, could not bend it/ can't bend her leg/ limited rom per pt, muscles are sore around the area/ muscle pain, feels like the knee was going forward and back and was afraid she might fall, it was very painful and different than before the inj/inj site was painful/lots of pain/acute pain in left knee/ left knee pain/ tenderness/ pain in right knee, drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid, can't function for myself or to take care of my daughter, unable to bear weight, leg swelling, hypercholesterolemia, prediabetes, acute bronchitis, unspecified organism, painful walking, crepitus, pain in her knee, back and shoulders, chronic left lateral breast tenderness, red papulovesicular rash, dysuria, tension headache, depressed, fatigue, difficulty sleeping, cramps, anxiety/ anxious, allergic reaction, insomnia, depressed, heightened irritability, negative thinking and moments of despair past medication included synvisc (3 injs in the knee; years ago), cortisone inj (last year or early this year) and kenalog (10 months ago).Relevant medical history had repair of torn meniscus (b)(6) 2017), tkr in the right knee (2008), knee arthroscopy (b)(6) 2017).It was reported that both the knees were bone on bone.Pt was not allergic to avian proteins, feathers, or egg products.Prior to the inj, the pt could stand and walk.Her past medical history included meniscus pain, endometrial ablation, wisdom tooth extraction, pharyngitis, upper respiratory infection, swelling, itchy rash eyelids.Pt's concurrent conditions included neck strain, chronic pain, left breast mass, allergic rhinitis, thyroid nodule, overweight, perimenopausal vasomotor symptoms, eyelid dermatitis, grief, left knee pain, stiffness, left knee medial meniscus tear, chondromalacia, alcohol user, back problem, chronic back pain and lipoma of torso.She had vaccine of tdap, zostavax, prevnar, pneumovax and influenza, injectable, quadrivalent, preservative free.She had mammogram(b)(6) 2016) and colonoscopy.Her family history include that her step father died because of stroke.Her father had history of diabetes, depression, stomach cancer and alcoholism.Her mother had medical history of macular degen, cataract, glaucoma, ddd, scoliosis and breast cancer.Her brother had medical history of high cholesterol, aortic aneurism, hypertension and alcohol/ drug use.Her other family member had history of hypertension.Her concomitant medication included triamcinolone acetonide (kenalog); cetirizine hydrochloride (zyrtec), fexofenadine hydrochloride (allegra), celecoxib (celebrex), cyclobenzaprine hydrochloride (flexeril) fluticasone propionate (flonase), calcium, colecalciferol (calcium + d3), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (centrum silver adults 50+), ondansetron (zofran), midazolam hydrochloride (versed), calcium chloride, potassium chloride, sodium lactate (lactated ringers), fentanyl (sublimaze ), propofol (diprivan); lidocaine (xylocaine), ephedrine (ephedrine), dexamethasone sodium phosphate (decadron), macrogol, potassium chloride, sodium bicarbonate (nulytely), valaciclovir hydrochloride (valtrex), hydromorphone hydrochloride (dilaudid), prochlorperazine maleate (compazine), sodium chloride (sodium chloride 0.9%), iopamidol (isovue 300), paracetamol (tylenol), azithromycin (zithromax), ibuprofen (ibuprofen), diphenhydramine hydrochloride, pseudoephedrine hydrochloride (sudafed), hydrocodone bitartrate, paracetamol (vicodin), bupropion hydrochloride (wellbutrin), duloxetine hydrochloride (cymbalta), hydrocodone bitartrate, paracetamol (norco), esomeprazole magnesium (nexium), metaxalone and gabapentin.On (b)(6) 2017, pt received treatment with intra-articular synvisc one inj, at dose of 6 ml once for end-stage arthritis of the knee (lot number and expiration date: not reported) in left knee.Pt did not engage in activities such as jogging or tennis soon after inj.Immediately following the inj, she could move around as normal.On an unknown date in (b)(6) 2017, few days after initiating treatment, it was very painful and different than before inj.Few days later site was sore, like a bruise.Pt stated that when fluid goes in, it goes in like a bunch and she was still mobile then.It was huge out in front of knee now.The weekend following inj, she felt like she had a fever that would come and go (latency: few days).Pt took paracetamol (tylenol) for it.Pt was having pain everywhere and inj was supposed to help her (latency: few days).Pt had not felt such pain except after right knee replacement (in 2008).By day 5 or 6, pt felt sick (latency: few days).Pt had flu, feeling more lethargic (latency: few days) and pt rested a lot.On day 9, it swelled and day 10, pt could not bend it and couldn't get around and day 11, pt couldn't bend it and was in lots of pain (latency: few days).The muscles were sore around the area and she was on crutches due to swelling (latency: few days).Pt said it felt like the knee was going forward and back and was afraid she might fall.Pt tried tried a knee brace, but took it off due to the swelling.On evaluation of (b)(6) 2017, it was observed that pt presented with left knee pain status post inj.Inj was given two weeks ago, pain was started one week ago.It was sharp, severe, diffuse, constant, worse with movement.Some swelling and bruising was also observed and had recent fever.On same day, pt had lab of arthrocentesis and 30 cc of fluid was extracted.The surgeon said he was not in until (b)(6) 2017 and to go to er.Pt took 2 celecoxib a day before, but physician told pt to take one now.Pt took 2 paracetamol to help with pain.Pt iced and elevated knee as well.On (b)(6) 2017, pt could hardly walk and had to use crutches.On same day, during lab analysis appearance of synovial fluid was cloudy.Pt took a taxi to emergency room (er).Pt was running a fever on and off and took paracetamol rested and drank plenty of fluids.Reportedly, pt was not hospitalized.Pt stated that everyday knee swells up so big and so painful.She was on crutches.I could not stand pain.She had to elevate and ice.It did't go away.It just kept swelling.She was going to go back he er to get more fluid taken off (onset: (b)(6) 2017; latency: few days).It was so painful that pt was in tears.She couldn't function for herself or take care of her daughter (onset: (b)(6) 2017; latency: few days).On (b)(6) 2017, pt underwent medical evaluation and found that pt had leg swelling, arthralgia, gait problem and joint swelling.Pt had decreased range of motion, swelling and effusion.On (b)(6) 2017, she again underwent in lab of arthrocentesis and 65 cc of fluid was extracted.She said her knee kept swelling up and was so painful.On (b)(6) 2017, pt underwent lab analysis and it was observed that platelet count was 472 10e3/ul (high), potassium was 5.5 meq/l (high), ldl-chol, direct was 159 mg/dl (high).On (b)(6) 2018, she went lab analysis and it was observed that cholesterol was 268 mg/dl (high), triglyceride was 220 mg/dl (high), ldl was 165 optimal mg/dl (high) and non-hdl cholesterol was 209 optimal mg/dl (high), potassium was 5.5 meq/l (high) and glucose was 107 mg/dl (high).On (b)(6) 2018, pt had a psychotherapy session and she was fully oriented and coherent, with good attention and concentration.Overall, there was no evidence of cognitive impairment.Her mood was both anxious and depressed.Since date of injury, she continued to report significant lifestyle changes and adjustment challenges, including loss of income, financial strain, and uncertain vocational future.She reported that stress tolerance had eroded producing heightened irritability, negative thinking, and moments of despair.She continued to complain of chronic pain and disability and had not been able to return to work since date of injury.Pt's physician recommended a total knee replacement.Complicating her case had been the determination of compensability, mmi (maximum medical improvement) status, vr (virtual reality), and rtw (return to work).This area of confusion between the carrier and her caregivers had created a secondary psychological injury because of the termination of pt, ttd checks and failure to authorize the recommended knee replacement surgery.Pt was diagnosed with adjustment disorder with anxiety & depressed mood.Pt's psychosocial stressors were: chronic pain, disability and disposition of her case.Tens was recommended for pain management since she tried it before with some success.Pt had subsequent psychotherapy sessions on (b)(6) 2018 (second), on (b)(6) 2018 (third), (b)(6) 2018 (fourth) and was noted to be same psychological state as noted before during first session.In fourth session, medical marijuana for pain, insomnia, and anxiety were recommend.On (b)(6) 2018, pt was suffering from cough, cough keeping pt awake at night, post nasal drip, sinus congestion and sore throat.On medical evaluation of (b)(6) 2018, it was observed that pt was diagnosed with acute bronchitis, unspecified organism.It was observed that pt was suffering prediabetes and hypercholesterolemia.On 17-apr-2018, she had fifth psychotherapy session noted with same psychological state.Information received on (b)(6) 2018 that pt have severe pain and was still suffering.Pt had contaminated lot, was drained 3 times but her tests did not show contamination.On medical evaluation of (b)(6) 2018, pt experienced other acute postprocedural pain.It was also reported that pt continued to have some problem with left knee, which got worse recently, seen at urgent care due to pain and swelling.On (b)(6) 2018, pt underwent lab analysis and it was observed that glucose was 100 mg/dl (high).Potassium was 5.2 mmol/l (high).On the same day, during mri examination it was observed that pt was having moderate to severe chondromalacia of triarticular surfaces, not bone to bone.Pt refused to have synvisc one inj since in past she had severe reaction.She was having lot of pain.She requested for total knee arthroplasty.On evaluation (b)(6) 2018, she was very active previously, but experienced setbacks and decreased activity when she started having knee problems then surgery in 2008.Still experiences significant pain in her right knee (tkr 2008), left knee scope in 2017, waiting to find out if she will have surgery on that knee.She also experienced pain in her lower back/hips and shoulders.On (b)(6) 2018, pt had sixth psychotherapy session and during the session it was stated that her physician recommended for mri of the left knee and surgical consult.Medications celebrex, tramadol, tylenol, and nexium were recommended.On evaluation of (b)(6) 2018, pt was still suffering for significant pain in her knee, back and shoulders.She stated that she felt trapped by pain she suffers, not able to leave house on some days because pain was so debilitating.She could stand upright or in certain positions for too long.Also noted that the pt had not been able to work, and she admitted that money was tight.She became tearful while talking about her pain and how it was interfering with her life.On (b)(6) 2018, pt had her seventh psychotherapy session.On (b)(6) 2018, during examination she was observed with chronic left lateral breast tenderness, red papulovesicular rash on inflamed base bilat axilla and was wearing left knee brace.On (b)(6) 2018, she had an mri of the left knee and was recommended for a surgical consult.On (b)(6) 2018, during the eighth psychotherapy session, it was reported that she was supported on food stamps and welfare income supplements.On 20-sep-2018, she met with physician and physician recommended a total knee replacement.But her employer denied the surgery.On (b)(6) 2018, (b)(6) 2018, (b)(6) 2018 (last one) pt had subsequent psychotherapy session.On the evaluation of (b)(6) 2018, pt complained of acute on chronic back pain and right shoulder pain.On (b)(6) 2019, it was reported that for treatment of end stage arthritis of knee, it was suggested that pt should undergo total knee arthroplasty (replacement).Physician recommended total knee arthroplasty but she wanted second opinion.She has had injs in past but had synvisc but states this caused severe pain afterwards.Now she felt she could no longer tolerate knee pain and wanted surgery.She was being managed by physician who did a knee arthroscopy and reported full-thickness, stage 4 chondromalacia throughout her knee.Follow-up recommendation was that she had total knee arthroplasty as well.She has had total knee arthroplasty on her right with great success.She felt that pain and dysfunction caused by her knee were severely affecting her life.On unknown date, she had fatigue, dysuria, anxiety, cramps and tension headaches.Corrective treatment: using crutches for can hardly walk/couldn't get around/not being mobile, crutches, iced and elevated the knee for it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; iced the knee, celecoxib (celebrex), tramadol, paracetamol for site was sore, like a bruise and it was very painful and different than before the inj/inj site was painful/lots of pain; paracetamol (tylenol), rested, and drank plenty of fluids for fever on and off/felt like she had a fever that would come and go; paracetamol for having pain everywhere, felt sick, flu, muscles were sore around the area; rested for lethargic; knee brace for feels like the knee was going forward and back and was afraid she might fall; marijuana for anxiety/ anxious and insomnia and not reported for rest outcome: unknown for can't function for myself or to take care of my daughter, total knee arthroplasty (replacement), unable to bear weight, leg swelling, hypercholesterolemia, prediabetes, acute bronchitis, unspecified organism, painful walking, crepitus, pain in her knee, back and shoulders, chronic left lateral breast tenderness, red papulovesicular rash, dysuria, tension headache, depressed, fatigue, difficulty sleeping, cramps and anxiety/ anxious, insomnia, depressed, heightened irritability, negative thinking and moments of despair; recovered for drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid; not recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51310 the product lot number was not provided; therefore a batch record review was not possible.Based on lack of information provided, no capa was required.It was requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through 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 would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp, unable to bear weight, it was huge out in front of knee now/it swelled; intervention required for knee pain and joint swelling additional information was received on 18-dec-2017 and 21-dec-2017 (processed with clock start date of 18-dec-2017) from the pt.Event of can't function for myself or to take care of my daughter and drained my knee/experiencing fluid build up/leg still fills up with fluid was added.Event term was updated to can hardly walk/couldn't get around/not being mobile; event term updated to it is huge out in front of the knee now/it swelled/it swells up so big/knee keeps swelling up; event of could not bend it was updated to could not bend it/ can't bend her leg; event term was updated to it was very painful and different than before the inj/inj site was painful/lots of pain/acute pain in left knee.Follow up information was received on 12-jan-2018.No new information received additional information was received on 23-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 23-apr-2018.Clinical course updated.Additional information was received on 21-may-2019 from lawyer.Case has been updated to legal case.Concomitant medications were added.Her medical history was added.Additional events of total knee arthroplasty (replacement), unable to bear weight, leg swelling, hypercholesterolemia, prediabetes, painful walking, acute bronchitis, unspecified organism, crepitus, pain in her knee, back and shoulders, chronic left lateral breast tenderness, red papulovesicular rash, dysuria, tension headache, depressed, fatigue, difficulty sleeping, cramps and anxiety.Verbatim updated to can hardly walk/couldn't get around/not being mobile/unable to walk/ walk with limp.Verbatim updated to could not bend it/ can't bend her leg/ limited rom per pt.Verbatim was updated muscles are sore around the area/ muscle pain.Verbatim was updated to it was very painful and different than before the inj/inj site was painful/lots of pain/acute pain in left knee/ left knee pain/ tenderness/ pain in right knee.Verbatim was updated to drained my knee/experiencing fluid build up/leg still fills up with fluid/ aspirated 30 cc serosanguinous fluid.Additional information was received on 12-jul-2019 from lawyer.Additional events of insomnia, depressed, heightened irritability, negative thinking and moments of despair were added.Verbatim for anxiety was updated to anxiety/ anxious.Corrective treatment of marijuana was added.Clinical course updated and text amended accordingly.
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