| Lot Number 9RSL001ZE |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Loss of Range of Motion (2032); Arthralgia (2355); Ambulation Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 11/01/2020 |
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Event Type
Injury
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Event Description
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Was not able to walk, knees became swollen, swelling of r knee, knees drained, arthrocentesis.Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one".Patient id: (b)(6); country: (b)(6) study title: patient support program involving synvisc one.This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot 9rsl001ze) for osteoarthritis in right knee.On the dec-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events.Outcome: recovered for all the events.Reporter causality: related for all the events.Company causality: reportable for all the events.
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Manufacturer Narrative
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Sanofi company comment on (b)(6) 2021: based on the limited information provided regarding this case, causal role of the company suspect product i.E.Hylan g-f 20, sodium hyaluronate in causing unable to walk, joint swelling and arthrocentesis cannot be established.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
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Manufacturer Narrative
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Sanofi company comment on (b)(6) 2021: based on the limited information provided regarding this case, causal role of the company suspect product i.E.Hylan g-f 20, sodium hyaluronate in causing unable to walk, joint swelling and arthrocentesis cannot be established.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
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Event Description
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Was not able to walk, knees became swollen, swelling of r knee, knees drained, arthrocentesis.Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one".Patient id: (b)(6); country: (b)(6) study title: patient support program involving synvisc one.This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot 9rsl001ze) for osteoarthritis in right knee.On the (b)(6) 2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events.Outcome: recovered for all the events.Reporter causality: related for all the events.Company causality: reportable for all the events.
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Event Description
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Was not able to walk [unable to walk].Knees became swollen [swelling of r knee].Knees drained [arthrocentesis].Case narrative: initial information received on 16-nov-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: canada.Study title: patient support program involving synvisc one.This case involves a 58-year-old female patient who was not able to walk, her knees became swollen and her knees drained with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid solution, 48mg/6ml at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze; expiry date: 30-nov-2021) for osteoarthritis in right knee.On the (b)(6) 2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events.Outcome: recovered for all the events.Reporter causality: related for all the events.Company causality: reportable for all the events.A product technical complaint (ptc) was initiated on 26-oct-2021 for synvisc one (lot number 8rsl051d) with global ptc number (b)(4).The production and quality control documentation for lot # 9rsl001ze, with expiration date 2021-11 was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review& lot # frequency analysis for lot # 9rsl001ze no capa(corrective and preventive action) is required.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.This review has not indicated any safety issue.As of 01dec21 there are6 complaints on file for lot# 9rsl001z and all related sublots.1 complaint is on file for lot# 9rsl001z: (1)adverse event report.5 complaints are on file for lot# 9rsl001ze: (5) adverse event reports.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed on 30-nov-2021 and conclusion summarized as no assessment possible.Additional information was received on 30-nov-2021 from the quality department.Ptc results received and processed.Formulation, strength updated.Text amended accordingly.
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Event Description
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Was not able to walk [unable to walk] knees became swollen [swelling of r knee] knees drained [arthrocentesis] was hard time getting out of bed [difficulty in standing] unable to walk or bend her knees [joint range of motion decreased] lot of pain; excruciating pain; pain in her knee [injection site joint pain] she might be allergic to it or maybe it was too much in one time.[allergic reaction nos] did not really work with no reported adverse event [device ineffective] case narrative: initial information received on 16-nov-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: canada study title: patient support program involving synvisc one.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves a 58-year-old female patient who was not able to walk, knees became swollen, knees drained, lot of pain; excruciating pain; pain in her knee, unable to walk or bend her knees and did not really work with no reported adverse event and she might be allergic to it or maybe it was too much in one time, was hard time getting out of bed while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), and family history were not provided.Concomitant medications included vitamin d nos (vitamin d nos); glycerol (glycerin [glycerol]); calcium, magnesium (calcium;magnesium); and curcuma longa (turmeric [curcuma longa]).On 17-nov-2020, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid solution, 48mg/6ml at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze; expiry date: 30-nov-2021) for osteoarthritis in right knee.In nov-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Patient returned a sanofi reminder call and mentioned that she had a synvisc- one injection in both knees for severe osteoarthritis.Patient thought it did not really work for her (device ineffective) (onset: nov-2020; latency: approx.2 weeks).She said that her knees felt weird/strange and that about a week to a week and a half later she had a reaction to the injections.Patient thought she might be allergic to it or maybe it was too much in one time (hypersensitivity)(onset: nov-2020; latency: approx.2 weeks.She woke up and her knees became very swollen, the swelling started a week later and it kept swelling.She could hardly walk and had excruciating pain (injection site joint pain) (onset: nov-2020; latency: approx.2 weeks).Patient did say she had some pain in her left knee before the injection.She said she felt that her knees would explode due to the swelling.She had a hard time getting out of bed (dysstasia) (nov-2020; latency: approx.2 weeks), was unable to walk or bend her knees (joint range of motion decreased) (onset: nov-2020; latency: approx.2 weeks).She felt in worse shape after having the injections.She returned to the physician in a wheelchair so that her knees could be drained.There was a lot of fluid removed and then she received cortisone shots in each knee, which helped with the pain.The swelling went down within a few days and she was able to walk and bend her knees.All this took place during covid.Patient after three years, because of covid was able to get a physical with her physician.She mentioned she walks on her lunch breaks, however damp weather was really bad for her.She takes turmeric pills, vitamin d (for five years now), calcium with magnesium, and glycerin cryoterine.The patient also mentioned it was the only time she received injections.Since march she was experiencing a lot of pain and was in the process of changing ortho surgeons.She would like a second opinion.The injection we have in our system was a synvisc-one injection in each knee on tuesday, november 17 2020 for osteoarthritis.Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; cortisone (cortisone) for injection site joint pain; arthrocentesis for rest both the events.Outcome: unknown for she might be allergic to it or maybe it was too much in one time, device ineffective; recovered for all the other events.Reporter causality: not reported device ineffective,dysstasia, hypersensitivity,joint range of motion decreased, injection site joint pain and related for all the other events.Company causality: not reportable for the events device ineffective,dysstasia, hypersensitivity, joint range of motion decreased, injection site joint pain and reportable for all the other events.A product technical complaint (ptc) was initiated on 26-oct-2021 for synvisc one (lot number 8rsl051d) with global ptc number 100169520.The production and quality control documentation for lot # 9rsl001ze, with expiration date 2021-11 was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review& lot # frequency analysis for lot # 9rsl001ze no capa(corrective and preventive action) was required.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reported 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.This review has not indicated any safety issue.As of 01dec21 there are6 complaints on file for lot# 9rsl001z and all related sublots.1 complaint is on file for lot# 9rsl001z: (1)adverse event report.5 complaints are on file for lot# 9rsl001ze: (5) adverse event reports.Sanofi will continue to monitor complaints to determine if a capa was required.Final investigation was completed on 30-nov-2021 and conclusion summarized as no assessment possible.Seriousness criteria: disability for gait inability, joint range of motion decreased and intervention required for gait inability, joint range of motion decreased, injection site joint pain, aspiration joint, joint swelling.Additional information was received on 30-nov-2021 from the quality department.Ptc results received and processed.Formulation, strength updated.Text amended accordingly.Additional information was received on 16-may-2023 from patient.Event device ineffective, joint joint range of motion decreased, injection site joint pain,dysstasia, hypersensitivity added; concomitants added; text amended.
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Event Description
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Was not able to walk [unable to walk] knees became swollen [swelling of r knee] knees drained [arthrocentesis] was hard time getting out of bed [difficulty in standing] unable to walk or bend her knees [joint range of motion decreased] lot of pain; excruciating pain; pain in her knee [injection site joint pain] she might be allergic to it or maybe it was too much in one time.[allergic reaction nos] did not really work with no reported adverse event [device ineffective] case narrative: initial information received on 16-nov-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: canada study title: patient support program involving synvisc one.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves a 58-year-old female patient who was not able to walk, knees became swollen, knees drained, lot of pain; excruciating pain; pain in her knee, unable to walk or bend her knees and did not really work with no reported adverse event and she might be allergic to it or maybe it was too much in one time, was hard time getting out of bed while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), and family history were not provided.Concomitant medications included vitamin d nos (vitamin d nos); glycerol (glycerin [glycerol]); calcium, magnesium (calcium;magnesium); and curcuma longa (turmeric [curcuma longa]).On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid solution, 48mg/6ml at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze; expiry date: 30-nov-2021) for osteoarthritis in left knee.In nov-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Patient returned a sanofi reminder call and mentioned that she had a synvisc- one injection in both knees for severe osteoarthritis.Patient thought it did not really work for her (device ineffective) (onset: nov-2020; latency: approx.2 weeks).She said that her knees felt weird/strange and that about a week to a week and a half later she had a reaction to the injections.Patient thought she might be allergic to it or maybe it was too much in one time (hypersensitivity)(onset: nov-2020; latency: approx.2 weeks.She woke up and her knees became very swollen, the swelling started a week later and it kept swelling.She could hardly walk and had excruciating pain (injection site joint pain) (onset: nov-2020; latency: approx.2 weeks).Patient did say she had some pain in her left knee before the injection.She said she felt that her knees would explode due to the swelling.She had a hard time getting out of bed (dysstasia) (nov-2020; latency: approx.2 weeks), was unable to walk or bend her knees (joint range of motion decreased) (onset: nov-2020; latency: approx.2 weeks).She felt in worse shape after having the injections.She returned to the physician in a wheelchair so that her knees could be drained.There was a lot of fluid removed and then she received cortisone shots in each knee, which helped with the pain.The swelling went down within a few days and she was able to walk and bend her knees.All this took place during covid.Patient after three years, because of covid was able to get a physical with her physician.She mentioned she walks on her lunch breaks, however damp weather was really bad for her.She takes turmeric pills, vitamin d (for five years now), calcium with magnesium, and glycerin cryoterine.The patient also mentioned it was the only time she received injections.Since march she was experiencing a lot of pain and was in the process of changing ortho surgeons.She would like a second opinion.The injection we have in our system was a synvisc-one injection in each knee on tuesday, (b)(6) 2020 for osteoarthritis.Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; cortisone (cortisone) for injection site joint pain; arthrocentesis for rest both the events.Outcome: unknown for she might be allergic to it or maybe it was too much in one time, device ineffective; recovered for all the other events.Reporter causality: not reported device ineffective,dysstasia, hypersensitivity,joint range of motion decreased, injection site joint pain and related for all the other events.Company causality: not reportable for the events device ineffective,dysstasia, hypersensitivity, joint range of motion decreased, injection site joint pain and reportable for all the other events.A ptc (product technical complaint) was initiated on 17-may-2023, for synvisc one (lot: 9rsl001ze, expiry date: 30-nov-2021) with global ptc number 100328264.The sample was not available.The ptc stated that based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii - (dp17may23).Batch # 9rsl001ze, synvisc one was manufactured on 08dec2018 with expiration date of 30nov2021 yielding 3,595 singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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 nonconforming material or product process.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Customer sample was not available.Root cause could not be determined.There are a total of 13 complaints for mother lot 9rsl001z and sub-batches.60707 9rsl001zb temperature excursion 61254 9rsl001zb temperature excursion61787 9rsl001zc expiration dating 100081518 9rsl001ze adverse event100089476 9rsl001ze adverse event100107416 9rsl001z adverse event100110334 9rsl001ze without / not enough effect100175904 9rsl001ze adverse event100175906 9rsl001ze adverse event100218818 9rsl001ze adverse event100226246 9rsl001ze without / not enough effect100328264 9rsl001ze adverse event / without-not enough effect100328267 9rsl001ze adverse event / without-not enough effect.There was no quality related defect that would attribute to a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reported 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.This review has not indicated any safety issue.Based on investigation and trend analysis, no capa (corrective and preventive actions) required.Sanofi will continue to adverse events.Trend analysis will be performed on a periodic basis "product event handling" to determine if a capa was required.The final investigation was completed on 02-jun-2023 with summarized conclusion as no assessment possible.Seriousness criteria: disability for gait inability, joint range of motion decreased and intervention required for gait inability, joint range of motion decreased, injection site joint pain, aspiration joint, joint swelling.Additional information was received on 30-nov-2021 from the quality department.Ptc results received and processed.Formulation, strength updated.Text amended accordingly.Additional information was received on 16-may-2023 from patient.Event device ineffective, joint joint range of motion decreased, injection site joint pain,dysstasia, hypersensitivity added; concomitants added; text amended.Additional information was received on 02-jun-2023 via quality department.Ptc details updated.Text amended.
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Search Alerts/Recalls
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