| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Synovitis (2094); Ambulation Difficulties (2544)
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| Event Date 12/25/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated 10-mar-2023: this case involves a 48 years old female patient who , couldn't walk well/difficulty walking, began to feel inflammation of the knee/synovitis with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.
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Event Description
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Couldn't walk well/difficulty walking [walking difficulty].Began to feel inflammation of the knee/synovitis [synovitis of knee].([burning sensation in joints worsened], [injection site joint swelling], [injection site joint discomfort], [injection site joint redness], [injection site joint pain], [condition worsened]).Back pain [back pain].Waist pain/gastrointestinal pain [lower abdominal pain].Poor appetite [decreased appetite].Contractures [contracture of lower leg joint].Headache [headache].Nausea [nausea].Went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event) [off label use of device].Case narrative: initial information received on 08-mar-2023 from peru regarding an unsolicited valid serious case received from the patient.This case involves a 48 years old female patient who experienced back pain, waist pain/gastrointestinal pain , poor appetite, contractures, headache, nausea, couldn't walk well/difficulty walking, began to feel inflammation of the knee/synovitis and went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event), gastrointestinal pain, burning sensation with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included cartilage tear in knee.The patient's past medical treatment(s) and family history were not provided.The patient does not suffer from other diseases or take other medications.On (b)(6) 2022, the patient received synvisc injection 1 df(dosage form) 1x (once) via intra-articular route (with an unknown batch number, expiry date, strength) for chondromalacia.Information on batch number was requested.The patient mentions that on (b)(6) 2022, she bought the product and on (b)(6) 2022, she went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (off label use) (latency same day), given that she had a cartilage tear from make excessive physical effort for sport.From the day of the application, the patient felt discomfort in her knee (injection site joint discomfort) (same day latency), however, her doctor told her that it was normal and told her to rest for 3 days.The patient complied, however, as of (b)(6) 2022 after a latency of 3 days , the patient began to go out to do her normal activities and began to feel inflammation of the knee(synovitis; onset: (b)(6) 2022) (latency 4 days), contracture (joint contracture) (latency: 3 days), a burning sensation in the area (arthralgia) (latency: 3 days), difficulty walking (gait disturbance) (latency: 3 days), and a lot of pain(injection site joint pain) (latency: 3 days).The symptoms worsened over time (condition aggravated) (latency: 4 days), so on (b)(6) 2022, she went to the emergency room, and they applied injectable anti-inflammatories, and they left her with oral anti-inflammatories and ice application in the injection area as a corrective treatment at home.Subsequently, she went to see another doctor who told her to have an mri and as a result told her that she had synovitis and that she should undergo physical therapy, for which she has followed 20 sessions, but to date she still has difficulty walking as a sequel (gait disturbance).She couldn't walk well (gait disturbance), red knee (injection site joint erythema), knee swelling (joint swelling), waist pain, (abdominal pain lower) back pain, contractures, headache, nausea, poor appetite decreased appetite.The reporter does not provide further information.Patient did not experience any additional symptoms/events.Upon follow up the patient mentioned that to date she only uses ice and oral anti-inflammatories when the pain is recurrent and as a consequence she cannot walk well, in addition that she had required physical therapy, therefore, the gait disorder event was considered serious and medically significant as well as synovitis and aggravated condition events.The patient was concerned because she must do more physical therapy sessions to be able to walk correctly, and the doctor has told her that the product will take at least 6 months to be reabsorbed.Action taken: not applicable for all the events.Corrective treatment: physical therapy, injectable anti-inflammatories, oral anti-inflammatories and ice application in the injection area as a corrective treatment at home.Outcome: unknown for the event off label use; recovered for back pain, headache, decreased appetite and nauseas on (b)(6) 2022 and was not recovered / not resolved for all the other events.Seriousness criteria: medically significant for walking difficulty, synovitis of knee.A product technical complaint (ptc) was initiated, and the results were pending for the same.Additional information was received on 10-mar-2023 from patient.Event verbatim of abdominal pain lower was updated.Outcome of the event back pain, headache, decreased appetite and nauseas was updated from not recovered to recovered.Clinical course was updated and text amended accordingly.
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Manufacturer Narrative
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Sanofi company comment for follow up dated 20-mar-2023: follow up information received does not change prior case assessment.This case involves a 48 years old female patient who couldn't walk well/difficulty walking, began to feel inflammation of the knee/synovitis after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient required physical therapy, injectable anti-inflammatories, oral anti-inflammatories and ice application in the injection area as a corrective treatment for the events.Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s baseline status, past medications, injection technique, batch number, investigation results, and other risk factors, if any would aid in better case assessment.
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Event Description
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Couldn't walk well/difficulty walking [walking difficulty] began to feel inflammation of the knee/synovitis/performed a second mri, confirming knee synovitis [synovitis of knee] ([burning sensation in joints worsened], [injection site joint swelling], [injection site joint discomfort], [injection site joint redness], [injection site joint pain], [condition worsened]) back pain [back pain] waist pain/gastrointestinal pain [gastrointestinal pain] poor appetite [decreased appetite] contractures [contracture of lower leg joint] headache [headache] nausea [nausea] went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event) [off label use of device] case narrative: initial information received on 08-mar-2023 from peru regarding an unsolicited valid serious case received from the patient.This case involves a 48 years old female patient who went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event) and then couldn't walk well/difficulty walking, began to feel inflammation of the knee/synovitis/performed a second mri, confirming knee synovitis, back pain, waist pain/gastrointestinal pain, poor appetite, contractures, headache, and nausea with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included cartilage tear in knee.The patient's past medical treatment(s) and family history were not provided.The patient did not suffer from other diseases or take other medications.The patient mentions that on 21-dec-2022, she bought the product (synvisc one) and on (b)(6) 2022, she went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia given that she had a cartilage tear from make excessive physical effort for sport.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection at dose of 1 time in a year via intra-articular route (with an unknown batch number, expiry date, strength) for chondromalacia (off label use) (latency same day).There will be no information available on the batch number of this case.From the day of the application, the patient felt discomfort in her knee (injection site joint discomfort) (same day latency), however, her doctor told her that it was normal and told her to rest for 3 days.The patient complied, however, as of (b)(6) 2022 after a latency of 3 days , the patient began to go out to do her normal activities and began to feel inflammation of the knee (synovitis), contracture (joint contracture), a burning sensation in the area (arthralgia), difficulty walking (gait disturbance) and a lot of pain(injection site joint pain).The symptoms worsened over time (condition aggravated) (latency: 4 days), so on (b)(6) 2022, she went to the emergency room, and they applied injectable anti-inflammatories, and they left her with oral anti-inflammatories and ice application in the injection area as a corrective treatment at home.Subsequently, she went to see another doctor who told her to have an mri (magnetic resonance imaging) and as a result told her that she had synovitis and that she should undergo physical therapy, for which she had followed 20 sessions, but to date she still had difficulty walking as a sequel (gait disturbance).She couldn't walk well (gait disturbance), red knee (injection site joint erythema), knee swelling (joint swelling), waist pain/gastrointestinal pain (gastrointestinal pain), back pain, contractures, headache, nausea, and poor appetite (decreased appetite).Upon follow up the patient mentioned that to date she only used ice and oral anti-inflammatories when the pain was recurrent and as a consequence she could not walk well, in addition that she had required physical therapy, therefore, the gait disorder event was considered serious and medically significant as well as synovitis and aggravated condition events.The patient was concerned because she must do more physical therapy sessions to be able to walk correctly, and the doctor had told her that the product would take at least 6 months to be reabsorbed.The patient mentioned that last week (considered date: (b)(6) 2023) she went to see another specialist (traumatologist), and they performed a second mri, confirming knee synovitis.The physician indicated that the adverse incident would require physical therapy for 6 months to 1 year.The patient had not started these new therapy sessions yet and continued to use ice and oral anti-inflammatories, conditional on pain.Action taken: not applicable for all the events corrective treatment: physical therapy, injectable anti-inflammatories, oral anti-inflammatories and ice application in the injection area as a corrective treatment at home for all the events outcome: recovered on (b)(6) 2022 for the event back pain, was recovered on (b)(6) 2022 for the event headache, was recovered on (b)(6) 2022 for the event nausea, was recovered on (b)(6) 2022 for the event poor appetite, was not recovered for the event contractures, was not recovered for the event began to feel inflammation of the knee/synovitis/performed a second mri, confirming knee synovitis, was not recovered for the event couldn't walk well/difficulty walking, was unknown for the event went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event) and was recovered on 26-dec-2022 for the event waist pain/gastrointestinal pain.Seriousness criteria: medically significant and disability for gait disturbance and synovitis a product technical complaint (ptc) was initiated, and the results were pending for the same.Additional information was received on 10-mar-2023 from patient.Event verbatim of abdominal pain lower was updated.Outcome of the event back pain, headache, decreased appetite and nauseas was updated from not recovered to recovered.Clinical course was updated, and text amended accordingly.Additional information was received on 20-mar-2023 from patient.As reported term updated for synovitis.Lab data added.Clinical course was updated.Text amended accordingly.
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Event Description
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Couldn't walk well/difficulty walking [walking difficulty] began to feel inflammation of the knee/synovitis/performed a second mri, confirming knee synovitis/ tenosynovitis [tenosynovitis] ([burning sensation in joints worsened], [injection site joint swelling], [injection site joint discomfort], [injection site joint redness], [injection site joint pain], [condition worsened]) back pain [back pain] waist pain/gastrointestinal pain [gastrointestinal pain] poor appetite [decreased appetite] contractures [contracture of lower leg joint] headache [headache] nausea [nausea] went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event) [off label use of device] case narrative: initial information received on 08-mar-2023 from peru regarding an unsolicited valid serious case received from the patient.This case involves a 48 years old female patient who went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event) and then couldn't walk well/difficulty walking, began to feel inflammation of the knee/synovitis/performed a second mri (magnetic resonance imaging), confirming knee synovitis/ tenosynovitis, cannot do much physical effort, back pain, waist pain/gastrointestinal pain, poor appetite, contractures, headache, and nausea with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included cartilage tear in knee.The patient's past medical treatment(s) and family history were not provided.The patient did not suffer from other diseases or take other medications.The patient mentions that on (b)(6) 2022, she bought the product (synvisc one) and on (b)(6) 2022, she went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia given that she had a cartilage tear from make excessive physical effort/ exertion for sport.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection at dose of 1 time in a year via intra-articular route (with strength: 48mg/6ml, an unknown batch number, expiry date) for chondromalacia (off label use of device) (latency same day).There will be no information available on the batch number of this case.From the day of the application, the patient felt discomfort in her knee (injection site joint discomfort) (same day latency), however, her doctor told her that it was normal and told her to rest for 3 days.The patient complied, however, as of (b)(6) 2022 after a latency of 3 days, the patient began to go out to do her normal activities and began to feel inflammation of the knee (synovitis), contracture (joint contracture), a burning sensation in the area (arthralgia), difficulty walking (gait disturbance) and a lot of pain(injection site joint pain).The symptoms worsened over time (condition aggravated) (latency: 4 days), so on (b)(6) 2022, she went to the emergency room, and they applied injectable anti-inflammatories, and they left her with oral anti-inflammatories and ice application in the injection area as a corrective treatment at home.Subsequently, she went to see another doctor who told her to have an mri and as a result told her that she had synovitis and that she should undergo physical therapy, for which she had followed 20 sessions (since (b)(6) 2023), but to date she still had difficulty walking as a sequel (gait disturbance).She couldn't walk well (gait disturbance), red knee (injection site joint erythema), knee swelling (injection site joint swelling), waist pain/gastrointestinal pain (gastrointestinal pain), back pain, contractures (joint contracture), headache, nausea, and poor appetite (decreased appetite).Upon follow up the patient mentioned that to date she only used ice and oral anti-inflammatories when the pain was recurrent and as a consequence she could not walk well, in addition that she had required physical therapy, therefore, the gait disorder event was considered serious and medically significant as well as synovitis and aggravated condition events.The patient was concerned because she must do more physical therapy sessions to be able to walk correctly, and the doctor had told her that the product would take at least 6 months to be reabsorbed.The patient mentioned that last week (considered date: (b)(6) 2023) she went to see another specialist (traumatologist), and they performed a second mri, confirming knee synovitis and tenosynovitis (onset: (b)(6) 2023; latency: 3 months approximately).The patient had restarted these new therapy sessions in (b)(6) 2023 and continued to use ice and oral anti-inflammatories, conditional on pain.The physician indicated that the adverse incident would require physical therapy for 6 months to 1 year and her full recovery would take between 6 to 8 months (she was already in that process).The patient indicates that she could walk, but she could not do much physical effort as this causes her knee pain.The patient was considered recovered with sequelae.Action taken: not applicable for all the events corrective treatment: physical therapy, injectable anti-inflammatories, oral anti-inflammatories and ice application in the injection area as a corrective treatment at home for all the events outcome: recovered on (b)(6) 2022 for the event back pain, headache, nausea, poor appetite, waist pain/gastrointestinal pain; was recovered with sequelae on an unknown date in (b)(6) 2023 for the event began to feel inflammation of the knee/synovitis/performed a second mri, confirming knee synovitis/ tenosynovitis; was not recovered for the event couldn't walk well/difficulty walking, contractures, and was unknown for the event went to her rheumatologist, who told her to apply the product because she was diagnosed with chondromalacia (with no reported adverse event).Seriousness criteria: medically significant and disability for gait disturbance and tenosynovitis.A product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc one (batch number: unknown) with global ptc number 100309362.The sample status was not available.Based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.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 safety surveillance effort to detect safety signals." defect class has been updated to ii and no pv# is currently provided - ((b)(4)).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.There is no quality related defect that would attribute to a death or serious injury.Sanofi will continue to monitor adverse events to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 13-apr-2023 with summarized conclusion as no assessment possible.Additional information was received on 10-mar-2023 from patient.Event verbatim of abdominal pain lower was updated.Outcome of the event back pain, headache, decreased appetite and nauseas was updated from not recovered to recovered.Clinical course was updated, and text amended accordingly.Additional information was received on 20-mar-2023 from patient.As reported term updated for synovitis.Lab data added.Clinical course was updated.Text amended accordingly.Additional information was received on 09-may-2023 from patient.The event verbatim was updated to began to feel inflammation of the knee/synovitis/performed a second mri, confirming knee synovitis/ tenosynovitis.Ptc results along with strength was added.Text amended accordingly.
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Search Alerts/Recalls
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