| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Headache (1880); Arthralgia (2355); Joint Swelling (2356); Malaise (2359); Neck Pain (2433); No Code Available (3191)
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| Event Date 12/05/2017 |
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Event Type
Injury
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Event Description
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Feeling as though she had the plague [plague, unspecified] ([fatigue aggravated], [dry cough], [headache]).Can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg [joint range of motion decreased] inflammation [joint inflammation] ([swelling of r knee], [aching (r) knee], [stiff knees], [effusion (r) knee]).Simple tasks like sitting on the toilet were extremely difficult [activities of daily living impaired].Sore throat [sore throat].Night sweats without fever [night sweat].Ear infection [ear infection].Back and neck pain/upper back pain/lower and upper back pain [back pain] ([radiating pain]).Back and neck pain [neck pain].Stiffness and tightness in these areas bilaterally [musculoskeletal stiffness].Stiffness and tightness in these areas bilaterally [muscle tightness].Sinus infection [sinus infection].Irritates my left knee [discomfort in joints].Swelling on the left side of her face [swelling of face].Could barely walk/difficulty doing steps, limp when walking due to stiffness and swelling/difficulty walking [unable to walk].Malaise [malaise].Hip pain recurred/too much pressure on the hip and it just flared up [arthralgia aggravated].Case narrative: initial information received on 09-oct-2019 regarding an unsolicited valid serious case received from a patient from united states.This case involves a (b)(6) years old female patient (177.8 cm and (b)(6) kg) who experienced could barely walk/difficulty doing steps, limp when walking due to stiffness and swelling/difficulty walking (latency: same day), inflammation (latency: 1 day), can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg (latency: 1 day), simple tasks like sitting on the toilet were extremely difficult (latency: same day), sore throat, feeling as though she had the plague (latency: few days), night sweats without fever (latency: unknown), ear infection (latency: few days), back and neck pain/upper back pain/lower and upper back pain, back and neck pain, stiffness and tightness in these areas bilaterally (latency: few days), sinus infection (latency: unknown), difficulty doing steps, swelling on the left side of her face, irritates my left knee (latency: unknown), malaise (latency: few days) and hip pain recurred/too much pressure on the hip and it just flared up (latency: few days), while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included postoperative nausea and vomiting unspecified, postoperative nausea and vomiting, supraventricular tachycardia (svt) with last episode in (b)(6) 2016, thyroid disease, hypo, wear glasses.The past surgical history included arthroscopy shoulder with rotator cuff repair with laterality: left, arthroscopy shoulder, debridement, breast surgery (benign breast x1), cardiac ablation, colonoscopy, endometrial ablation with novasure, pelvic laparoscopy (removal of bilateral hydrosalpinges), shoulder surgery.It was reported that patient had chiropractic manipulative care in the past which was helpful.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing primary localized osteoarthritis of left hip and oa of knees.Concomitant medications included triamcinolone acetonide (kenalog) for primary localized osteoarthritis of left hip.On (b)(6) 2017 at 12:15 pm, patient vitals included: body mass index (bmi) 25.43; heart rate 75 beats/min; blood pressure 116/71 mm hg.On (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route, once (dosage, lot - unk) for primary osteoarthritis of right knee.Information regarding batch number was requested.On (b)(6) 2019, 12 hours post injection, patient had a reaction to the hylan g-f 20, sodium hyaluronate including inflammation and stiffness, knee was very swollen.The patient had difficulty doing steps, limped when walking due to stiffness and swelling and could not get the leg to support me to comfortably to get out of a chair, as it would not bend.Patient thought he would feel much better within the 72 hours as indicated.In the meantime, he would ice and take motrin/tylenol for inflammation.On same day, patient was freaked for the stiffness and how much it hurts.On (b)(6) 2017, a few hours later that same day, patient experienced severe pain and loss of range of motion and she could barely walk.On (b)(6) 2017, after one day, patient could not bend her leg, and simple tasks such as sitting on the toilet were extremely difficult and was started on a course of methylprednisolone (medrol) by her pcp a couple days later.After that, the swelling improved quickly, and the pain improved gradually.Both, however, returned to near her pre-synvisc baseline within a week.On an unknown date in (b)(6) 2017, (latency: few days) almost after a week of synvisc injection, the patient developed a sore throat and malaise.On an unknown date in 2017, after few days, later patient developed a cough and her fatigue worsened.The patient described this as feeling as though she had the plague.On an unknown date, patient visited an urgent care and was prescribed a z-pak which yielded some improvement, but then she developed night sweats without fever.It was reported that patient developed swelling on the left side of her face and had severe headache while her cough persisted.It was reported that patient again visited urgent care and was prescribed amoxicillin for 10 days which yielded some improvement but not a lot.On (b)(6) 2017, patient was informed that the injection used was contaminated may be with microbes or in light of risk of possible contamination with methylobacterium thiocyanatum.Patient was asked to inform if she sees any symptoms for infection.On an unknown date, after unknown latency, hip pain recurred during the days while she was having such difficulty with the knee inflammation, stiffness and difficulty walking following the injection to her right knee.Patient was still having the pain and it irritated her left knee when she walks too much.Patient might have put too much pressure on that hip and it just flared up and has not resolved.On an unknown date, after unknown latency, patient was diagnosed with an ear infection for which she was prescribed keflex which did the trick and her symptoms resolved within a few days on this regimen.On an unknown date in 2017, after few days, patient had back and neck pain which was continued with right knee pain, and believes that walking with a limp and favoring the knee was the probable reason for the onset of the back pain, which had spread into the upper back and neck and had been feeling stiffness and tightness in these areas bilaterally.Additionally, patient had left supraspinatus rotator cuff surgery (16 months ago,) which could have influence on the neck pain also.As of unknown date, patient had been to physical therapy and had message therapy in the left parascapular area and in the lower back region, but without lasting benefit.Patient had been doing some stretches and pilates machine and thought it was helpful.The more she walked, the more the pain seemed to give her trouble, particularly in the lower and upper back as the pain could vary from mild to moderate and from frequent to infrequent.On (b)(6) 2018, the patient vitals included blood pressure 104/54 mm hg.On (b)(6) 2018, patient was doing pretty well and her knee was nearly back to her baseline and she denied pain but knee felt different.As of now, there were no issues with range of motion with walking.Patient still had occasional dry cough but felt great and did not have other issues.Appetite and energy levels are okay.Patient was called to collect inflammatory markers (sed rate and c-reactive protein) to follow, all of which were normal.On (b)(6) 2018, the patient had aspiration of the right knee.On (b)(6) 2018, the patient consulted doctor for the chiropractor.On (b)(6) 2018, culture was done which included specific media for isolation of methylobacterium, but there was no aerobic or anaerobic growth or any gram stains and white blood cells.Based on lab results and current clinical presentation, it did not appear there was any acute infection.Patient was asked to notify any changes and if knee replacement surgery was on the table in the future, the ortho team would make sure to collect cultures/pathology samples to make sure all looks good before implanting the knee.On an unknown date, patient had sinus infection and had antibiotics and prednisone as the corrective treatment.Action taken: not applicable for all events.Corrective treatment: azithromycin (z-pak) for feeling as though she had the plague, sore throat, her fatigue worsened, malaise; ice and take ibuprofen (motrin)/ paracetamol (tylenol) and methylprednisolone (medrol) for inflammation; methylprednisolone (medrol) for can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg; azithromycin (z-pak), codeine-guaifenesin and benzonatate for cough/occasional dry cough; amoxicillin for night sweats without fever, severe headache, swelling on the left side of her face; cefalexin (keflex), antibiotics and prednisone for ear infection; has been to physical therapy and had message therapy in the left parascapular area and in the lower back region, some stretches, chiropractic manipulative care, does pilates for back and neck pain/upper back pain/lower and upper back pain and stiffness and tightness in these areas bilaterally; antibiotics and prednisone for sinus infection; not reported for rest all events.Outcome: unknown for irritates my left knee, stiffness, inflammation, back and neck pain/upper back pain/lower and upper back pain, stiffness and tightness in these areas bilaterally; recovering for knee is very swollen, simple tasks like sitting on the toilet were extremely difficult, sore throat, malaise, feeling as though she had the plague, swelling on the left side of her face; recovered for can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg, how much it hurt/severe pain, could barely walk/difficulty doing steps, limp when walking due to stiffness and swelling/difficulty walking, night sweats without fever, ear infection; not recovered for hip pain recurred/too much pressure on the hip and it just flared up and sinus infection.The product technical complaint (ptc) was initiated and the results were pending for the same.
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Event Description
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Feeling as though she had the plague [plague, unspecified] ([fatigue aggravated], [dry cough], [headache]).Can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/couldnt not bend her leg [joint range of motion decreased] inflammation [joint inflammation] ([swelling of r knee], [aching (r) knee], [stiff knees], [effusion (r) knee]).Simple tasks like sitting on the toilet were extremely difficult [activities of daily living impaired].Sore throat [sore throat].Night sweats without fever [night sweat].Ear infection [ear infection].Back and neck pain/upper back pain/lower and upper back pain [back pain] ([radiating pain]).Back and neck pain [neck pain].Stiffness and tightness in these areas bilaterally [musculoskeletal stiffness].Stiffness and tightness in these areas bilaterally [muscle tightness].Sinus infection [sinus infection].Irritates my left knee [discomfort in joints].Swelling on the left side of her face [swelling of face].Could barely walk/difficulty doing steps, limp when walking due to stiffness and swelling/difficulty walking [unable to walk].Malaise [malaise].Hip pain recurred/too much pressure on the hip and it just flared up [arthralgia aggravated].Case narrative: initial information received on (b)(6) 2019 regarding an unsolicited valid serious case received from a patient from united states.This case involves a 57 years old female patient (177.8 cm and 80.37 kg) who experienced could barely walk/difficulty doing steps, limp when walking due to stiffness and swelling/difficulty walking (latency: same day), inflammation (latency: 1 day), can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg (latency: 1 day), simple tasks like sitting on the toilet were extremely difficult (latency: same day), sore throat, feeling as though she had the plague (latency: few days), night sweats without fever (latency: unknown), ear infection (latency: few days), back and neck pain/upper back pain/lower and upper back pain, back and neck pain, stiffness and tightness in these areas bilaterally (latency: few days), sinus infection (latency: unknown), difficulty doing steps, swelling on the left side of her face, irritates my left knee (latency: unknown), malaise (latency: few days) and hip pain recurred/too much pressure on the hip and it just flared up (latency: few days), while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included postoperative nausea and vomiting unspecified, postoperative nausea and vomiting, supraventricular tachycardia (svt) with last episode in (b)(6) 2016, thyroid disease, hypo, wear glasses.The past surgical history included arthroscopy shoulder with rotator cuff repair with laterality: left, arhroscopy shoulder, debridement, breast surgery (benign breast x1), cardiac ablation, colonoscopy, endometrial ablation with novasure, pelvic laparoscopy (removal of bilateral hydrosalpinges), shoulder surgery.It was reported that patient had chiropractic manipulative care in the past which was helpful.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing primary localized osteoarthritis of left hip and oa of knees.Concomitant medications included triamcinolone acetonide (kenalog) for primary localized osteoarthritis of left hip.On (b)(6) 2017 at 12:15 pm, patient vitals included: body mass index (bmi) 25.43; heart rate 75 beats/min; blood pressure 116/71 mm hg.On (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route, once (dosage, lot - unk) for primary osteoarthritis of right knee.Information regarding batch number was requested.On (b)(6) 2019, 12 hours post injection, patient had a reaction to the hylan g-f 20, sodium hyaluronate including inflammation and stiffness, knee was very swollen.The patient had difficulty doing steps, limped when walking due to stiffness and swelling and could not get the leg to support me to comfortably to get out of a chair, as it would not bend.Patient thought he would feel much better within the 72 hours as indicated.In the meantime, he would ice and take motrin/tylenol for inflammation.On same day, patient was freaked for the stiffness and how much it hurts.On (b)(6) 2017, a few hours later that same day, patient experienced severe pain and loss of range of motion and she could barely walk.On (b)(6) 2017, after one day, patient could not bend her leg, and simple tasks such as sitting on the toilet were extremely difficult and was started on a course of methylprednisolone (medrol) by her pcp a couple days later.After that, the swelling improved quickly, and the pain improved gradually.Both, however, returned to near her pre-synvisc baseline within a week.On an unknown date in (b)(6) 2017, (latency: few days) almost after a week of synvisc injection, the patient developed a sore throat and malaise.On an unknown date in 2017, after few days, later patient developed a cough and her fatigue worsened.The patient described this as feeling as though she had the plague.On an unknown date, patient visited an urgent care and was prescribed a z-pak which yielded some improvement, but then she developed night sweats without fever.It was reported that patient developed swelling on the left side of her face and had severe headache while her cough persisted.It was reported that patient again visited urgent care and was prescribed amoxicillin for 10 days which yielded some improvement but not alot.On (b)(6) 2017, patient was informed that the injection used was contaminated may be with microbes or in light of risk of possible contamination with methylobacterlum thiocyanatum.Patient was asked to inform if she sees any symptoms for infection.On an unknown date, after unknown latency, hip pain recurred during the days while she was having such difficulty with the knee inflammation, stiffness and difficulty walking following the injection to her right knee.Patient was still having the pain and it irritated her left knee when she walks too much.Patient might have put too much pressure on that hip and it just flared up and has not resolved.On an unknown date, after unknown latency, patient was diagnosed with an ear infection for which she was prescribed keflex which did the trick and her symptoms resolved within a few days on this regimen.On an unknown date in 2017, after few days, patient had back and neck pain which was continued with right knee pain, and believes that walking with a limp and favoring the knee was the probable reason for the onset of the back pain, which had spread into the upper back and neck and had been feeling stiffness and tightness in these areas bilaterally.Additionally, patient had left suprespinatus rotator cuff surgery (16 months ago,) which could have influence on the neck pain also.As of unknown date, patient had been to physical therapy and had message therapy in the left parascapular area and in the lower back region, but without lasting benefit.Patient had been doing some stretches and pilates machine and thought it was helpful.The more she walked, the more the pain seemed to give her trouble, particularly in the lower and upper back as the pain could vary from mild to moderate and from frequent to infrequent.On (b)(6) 2018, the patient vitals included blood pressure 104/54 mm hg.On 10-(b)(6) 2018, patient was doing pretty well and her knee was nearly back to her baseline and she denied pain but knee felt different.As of now, there were no issues with range of motion with walking.Patient still had occasional dry cough but felt great and did not have other issues.Appetite and energy levels are okay.Patient was called to collect inflammatory markers (sed rate and c-reactive protein) to follow, all of which were normal.On (b)(6) 2018, the patient had aspiration of the right knee.On (b)(6) 2018, the patient consulted doctor for the chiropactor.On 2018, culture was done which included specific media for isolation of methylobacterium, but there was no aerobic or anaerobic growth or any gram stains and white blood cells.Based on lab results and current clinical presentation, it did not appear there was any acute infection.Patient was asked to notify any changes and if knee replacement surgery was on the table in the future, the ortho team would make sure to collect cultures/pathology samples to make sure all looks good before implanting the knee.On an unknown date, patient had sinus infection and had antibiotics and prednisone as the corrective treatment.Action taken: not applicable for all events.Corrective treatment: azithromycin (z-pak) for feeling as though she had the plague, sore throat, her fatigue worsened, malaise; ice and take ibuprofen (motrin)/ paracetamol (tylenol) and methylprednisolone (medrol) for inflammation; methylprednisolone (medrol) for can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg; azithromycin (z-pak), codeine-guaifenesin and benzonatate for cough/ocasssional dry cough; amoxicillin for night sweats without fever, severe headache, swelling on the left side of her face; cefalexin (keflex), antibiotics and prednisone for ear infection; has been to physical therapy and had message therapy in the left parascapular area and in the lower back region, some stretches, chiropractic manipulative care, does pilates for back and neck pain/upper back pain/lower and upper back pain and stiffness and tightness in these areas bilaterally; antibiotics and prednisone for sinus infection; not reported for rest all events.Outcome: unknown for irritates my left knee, stiffness, inflammation, back and neck pain/upper back pain/lower and upper back pain, stiffness and tightness in these areas bilaterally; recovering for knee is very swollen, simple tasks like sitting on the toilet were extremely difficult, sore throat, malaise, feeling as though she had the plague, swelling on the left side of her face; recovered for can't get the leg to support me to comfortably to get out of a chair, as it won't band/loss of range of motion/could not bend her leg, how much it hurt/severe pain, could barely walk/difficulty doing steps, limp when walking due to stiffness and swelling/difficulty walking, night sweats without fever, ear infection; not recovered for hip pain recurred/too much pressure on the hip and it just flared up and sinus infection.A product technical complaint was initiated on (b)(6) 2019 for synvisc one.Batch number: unknown global ptc number: 60633 the product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation complete date: (b)(6)2019 follow-up information was received on (b)(6) 2019.No new information was received.Additional information received on (b)(6)2019 from other healthcare professional.Investigation summary received and ptc results added.
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