| Lot Number CRSL008 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 12/03/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated (b)(6) 2022: this case involves a patient underwent drainage and is currently bedridden (cannot flex the knee), presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis, after 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 medical history, past medications, concomitant medications, batch number, ptc results, injection technique, post injection routine, and other risk factors would aid in better case assessment.
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Event Description
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Presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex / is currently bedridden (cannot flex the knee) [joint range of motion decreased] ([bedridden]).Presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis [arthritis aggravated] ([arthrocentesis], [aching (r) knee], [protein total high], [blood glucose increased], [joint effusion]).Patient could not walk well.[difficulty in walking].Case narrative: initial information received on (b)(6) 2022 regarding an unsolicited valid serious case received from peru via physician.This case involves a 52 years old female patient underwent drainage and is currently bedridden (cannot flex the knee)., presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis, patient could not walk well.And presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included gastritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received synvisc one injection (right knee) (lot - crsl008, expiry date: dec-2024, route: intra-articular, unknown dose, strength, frequency) for osteoarthritis and arthralgia.On (b)(6) 2022 the product was applied to the right knee, but the next day on (b)(6) 2022 the patient presented a marked and progressive increase in the right knee, making extension or flexion impossible (joint range of motion decreased) (latency 1 day) and presented inflammation of the knee and could not flex (arthritis; medically significant) (latency 1 day).On the fifth day ((b)(6) 2022) the patient went to the emergency room because the inflammation worsened, and the patient could not walk well (gait disturbance) (latency 1 day).Laboratory tests were carried out, presenting a negative culture and no crystals or immune reaction were evidenced, nor did the patient feel burning in the injection area.High level of proteins (protein total increased; medically significant) (latency 1 day), high blood glucose level (blood glucose increased; medically significant) (latency 1 day) and joint effusion (medically significant) (latency 1 day) were evidenced, for which the treating physician diagnosed chemical arthritis deteriorating joint.The patient underwent drainage (drainage; medically significant) (latency 1 day) and is currently bedridden (cannot flex the knee) (bedridden; disability, medically significant) (latency 1 day).As a corrective treatment, she only takes paracetamol conditional to pain (arthralgia; medically significant) (latency 1 day) and physical rehabilitation therapy has been indicated.Therefore, by searching the literature and discussing the case with the treating physician and finding no adverse events such as her mother's, it is concluded that the case corresponds to a problem with the batch of the molecule, and this corresponds to be investigated.Patient did not experience any additional symptoms/events.The patient did not have any additional medical history, concomitant disease or risk factor.There were no additional lab data/results available.The company suspect product was not inappropriately used as per local marketing authorization.Action taken: not applicable for the events.Corrective treatment: paracetamol for arthritis and not reported for other events.Outcome: recovering for the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.
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Event Description
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Presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex / is currently bedridden (cannot flex the knee)¿ [joint range of motion decreased] ([bedridden]).Presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis [arthritis aggravated] ([arthrocentesis], [aching (r) knee], [protein total high], [blood glucose increased], [joint effusion]).Patient could not walk well.[difficulty in walking].Case narrative: initial information received on 15-dec-2022 regarding an unsolicited valid serious case received from peru via patient's daughter (physician).This case involves a 52 years old female patient underwent drainage and is currently bedridden (cannot flex the knee)., presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis, patient could not walk well.And presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included gastritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient did not have any additional medical history, concomitant disease or risk factor.The patient was not taking any additional medication (no concomitant medications reported).On (b)(6) 2022, the patient received synvisc one injection liquid solution (right knee) (lot: crsl008, expiry date: 31-dec-2024, route: intra-articular, strength: 48 mg/6ml, unknown dose, frequency) for osteoarthritis and arthralgia.On (b)(6) 2022, the product was applied to the right knee, but the next day on (b)(6) 2022, the patient presented a marked and progressive increase in the right knee, making extension or flexion impossible (joint range of motion decreased) (latency 1 day) and presented inflammation of the knee and could not flex (arthritis; medically significant) (latency 1 day).On the fifth day on (b)(6) 2022) the patient went to the emergency room because the inflammation worsened, and the patient could not walk well (gait disturbance) (latency 1 day).Laboratory tests were carried out, presenting a negative culture and no crystals or immune reaction were evidenced, nor did the patient feel burning in the injection area.High level of proteins (protein total increased; medically significant) (latency 1 day), high blood glucose level (blood glucose increased; medically significant) (latency 1 day) and joint effusion (medically significant) (latency 1 day) were evidenced, for which the treating physician diagnosed chemical arthritis deteriorating joint.The patient underwent drainage (drainage; medically significant) (latency 1 day) and is currently bedridden (cannot flex the knee) (bedridden; disability, medically significant) (latency 1 day).As a corrective treatment, she only takes paracetamol conditional to pain (arthralgia; medically significant) (latency 1 day) and physical rehabilitation therapy has been indicated.Therefore, by searching the literature and discussing the case with the treating physician and finding no adverse events such as her mother's, it is concluded that the case corresponds to a problem with the batch of the molecule, and this corresponds to be investigated.Patient did not experience any additional symptoms/events.The reporter mention that the physical therapy was yet to be scheduled since she was being checked for rheumatologist next week, with which she would be referred and scheduled.The patient was recovering, even with pain on flexion, extension and standing.Action taken: not applicable for the events.Corrective treatment: paracetamol for arthritis, physical therapy for joint range of motion decreased, bedridden, gait disturbance and not reported for other events.Outcome: recovering for the events.A product technical complaint (ptc) was initiated on 15-dec-2022 for synvisc one (lot: crsl008, expiry date: 31-dec-2024) with global ptc number: (b)(4).The sample status was not available.Ptc was set in process.Additional information was received on 29-dec-2022 from physician (patient's daughter).Ptc number for lot number: crsl008 along with expiry date and strength were added.Text amended accordingly.
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Event Description
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Is currently bedridden.Presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex / is currently bedridden (cannot flex the knee)¿ [joint range of motion decreased].Joint effusion [joint effusion].Underwent drainage [arthrocentesis].Presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis [arthritis aggravated] ([aching (r) knee]).High level of proteins [protein total high].High blood glucose level [blood glucose increased].Patient could not walk well/ she can walk, although she still has some difficulty [difficulty in walking].Case narrative: initial information received on 15-dec-2022 regarding an unsolicited valid serious case received from peru via patient's daughter (physician).This case involves a 52 years old female is currently bedridden, presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex / is currently bedridden (cannot flex the knee), joint effusion, underwent drainage, presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis, high level of proteins, high blood glucose level and patient could not walk well/ she can walk, although she still has some difficulty with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included gastritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient did not have any additional medical history, concomitant disease or risk factor.The patient was not taking any additional medication (no concomitant medications reported).On (b)(6) 2022, the patient received synvisc one injection liquid solution (right knee) (lot - crsl008, expiry date: 31-dec-2024, route: intra-articular, strength: 48 mg/6ml, unknown dose, frequency) for osteoarthritis and arthralgia.On (b)(6) 2022 the product was applied to the right knee, but the next day on (b)(6) 2022 the patient presented a marked and progressive increase in the right knee, making extension or flexion impossible (joint range of motion decreased; medically significant) (latency 1 day) and presented inflammation of the knee and could not flex (arthritis; medically significant) (latency 1 day).On the fifth day ((b)(6) 2022) the patient went to the emergency room because the inflammation worsened, and the patient could not walk well (gait disturbance) (latency 1 day).Laboratory tests were carried out, presenting a negative culture and no crystals or immune reaction were evidenced, nor did the patient feel burning in the injection area.High level of proteins (protein total increased) (latency 1 day), high blood glucose level (blood glucose increased) (latency 1 day) and joint effusion (medically significant) (latency 1 day) were evidenced, for which the treating physician diagnosed chemical arthritis deteriorating joint.The patient underwent drainage (drainage; medically significant) (latency 1 day) and is currently bedridden (cannot flex the knee) (bedridden; disability, medically significant) (latency 1 day).As a corrective treatment, she only takes paracetamol conditional to pain (arthralgia; medically significant) (latency 1 day) and physical rehabilitation therapy has been indicated.Therefore, by searching the literature and discussing the case with the treating physician and finding no adverse events such as her mother's, it is concluded that the case corresponds to a problem with the batch of the molecule, and this corresponds to be investigated.Patient did not experience any additional symptoms/events.The reporter mention that the physical therapy was yet to be scheduled since she was being checked for rheumatologist next week, with which she would be referred and scheduled.The patient was recovering, even with pain on flexion, extension and standing.Upon follow up the daughter of the patient mentioned that the patient went to see a rheumatologist and was no longer bedridden, she can walk, although she still had some difficulty.Treatment with topical anti-inflammatories and celecoxib was indicated in case of pain.Physical therapy was also indicated, but she has not yet started her sessions.The patient is recovering favorably.Action taken: not applicable for the events.Corrective treatment: paracetamol for arthritis, physical therapy for joint range of motion decreased, bedridden, gait disturbance, celecoxib and anti-inflammatories for pain (right knee) and not reported for other events outcome: recovering for the events.A product technical complaint (ptc) was initiated on 15-dec-2022 for synvisc one (lot - crsl008, expiry date: 31-dec-2024) with global ptc number (b)(4).The sample status was not available.Ptc was set in process.Additional information was received on 29-dec-2022 from physician (patient's daughter).Ptc number for lot number: crsl008 along with expiry date and strength were added.Text amended accordingly.Additional information was received on 09-feb-2023 from patient daughter.Event verbatim of gait disturbance was updated.Treatment for pain (right knee) was added.Clinical course was updated and text amended accordingly.
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Event Description
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Is currently bedridden [bedridden]
presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex / is currently bedridden (cannot flex the knee)¿ [joint range of motion decreased]
joint effusion [joint effusion]
underwent drainage [arthrocentesis]
presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis [arthritis aggravated] ([aching (r) knee])
high level of proteins [protein total high]
high blood glucose level [blood glucose increased]
patient could not walk well/ she can walk, although she still has some difficulty [difficulty in walking]
case narrative: initial information received on 15-dec-2022 regarding an unsolicited valid serious case received from peru via patient's daughter (physician).This case involves a 52 years old female is currently bedridden, presented a marked and progressive increase in the right knee, making extension or flexion impossible/could not flex / is currently bedridden (cannot flex the knee), joint effusion, underwent drainage, presented inflammation of the knee; inflammation worsened /diagnosed chemical arthritis, high level of proteins, high blood glucose level and patient could not walk well/ she can walk, although she still has some difficulty with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included gastritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient did not have any additional medical history, concomitant disease or risk factor.The patient was not taking any additional medication (no concomitant medications reported).On 02-dec-2022, the patient received synvisc one injection (right knee) (lot - crsl008, expiry date: 31-dec-2024, route: intra-articular, strength: 48 mg/6ml, unknown dose, frequency) for osteoarthritis and arthralgia.On 02-dec-2022 the product was applied to the right knee, but the next day on 03-dec-2022 the patient presented a marked and progressive increase in the right knee, making extension or flexion impossible (joint range of motion decreased; medically significant) (latency 1 day) and presented inflammation of the knee and could not flex (arthritis; medically significant) (latency 1 day).On the fifth day (07-dec-2022) the patient went to the emergency room because the inflammation worsened, and the patient could not walk well (gait disturbance) (latency 1 day).Laboratory tests were carried out, presenting a negative culture and no crystals or immune reaction were evidenced, nor did the patient feel burning in the injection area.High level of proteins (protein total increased) (latency 1 day), high blood glucose level (blood glucose increased) (latency 1 day) and joint effusion (medically significant) (latency 1 day) were evidenced, for which the treating physician diagnosed chemical arthritis deteriorating joint.The patient underwent drainage (drainage; medically significant) (latency 1 day) and is currently bedridden (cannot flex the knee) (bedridden; disability, medically significant) (latency 1 day).As a corrective treatment, she only takes paracetamol conditional to pain (arthralgia; medically significant) (latency 1 day) and physical rehabilitation therapy has been indicated.Therefore, by searching the literature and discussing the case with the treating physician and finding no adverse events such as her mother's, it is concluded that the case corresponds to a problem with the batch of the molecule, and this corresponds to be investigated.Patient did not experience any additional symptoms/events.The reporter mention that the physical therapy was yet to be scheduled since she was being checked for rheumatologist next week, with which she would be referred and scheduled.The patient was recovering, even with pain on flexion, extension and standing.Upon follow up the daughter of the patient mentioned that the patient went to see a rheumatologist and was no longer bedridden, she can walk, although she still had some difficulty.Treatment with topical anti-inflammatories and celecoxib was indicated in case of pain.Physical therapy was also indicated, but she has not yet started her sessions.The patient is recovering favorably.Action taken: not applicable for the events
corrective treatment: paracetamol for arthritis, physical therapy for joint range of motion decreased, bedridden, gait disturbance, celecoxib and anti-inflammatories for pain (right knee) and not reported for other events
outcome: recovering for the events.A product technical complaint (ptc) was initiated on 15-dec-2022 for synvisc-one (batch number: crsl008; expiry dare: 31-dec-2024) with global ptc number: 100285382.The sample status of the ptc was received and stated that based on the complaint from intake team, there was 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 - (dp 15dec22) pv# was provided upon 2nd request 19dec22 - (dp 19dec22) the production and quality control documentation for lot # crsl008 expiration date (2024-12) was manufactured on 25jan22 packaged 6000 singles 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 # crsl008 no capa(corrective and preventive actions) was required.As of 19dec22 there are 4 complaints on file for lot# crsl008 and all related sublots.2 complaints are on file for lot#crsl008a: (1) luer lok system damage and (1) syringe tip broken1 complaint is on file for lot#crsl008b: (1) adverse event report.1 complaint is on file for lot#crsl008: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa was required.The final investigation was completed on 15-feb-2023 with summarized conclusion as no assessment possible
additional information was received on 29-dec-2022 from physician (patient's daughter).Ptc number for lot number: crsl008 along with expiry date and strength were added.Text amended accordingly.Additional information was received on 09-feb-2023 from patient daughter.Event verbatim of gait disturbance was updated.Treatment for pain (right knee) was added.Clinical course was updated and text amended accordingly.Additional information was received on 15-feb-2023 by quality department: complete ptc details added.Text amended.
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Manufacturer Narrative
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Sanofi company comment for follow up dated 15-feb-2023: the follow-up information does not change the overall case assessment.This case involves a patient who is currently bedridden (cannot flex the knee) and presented a marked and progressive increase in the right knee, making extension or flexion impossible, after 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 medical history, past medications, concomitant medications, batch number, ptc results, injection technique, post injection routine, and other risk factors would aid in better case assessment.
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Search Alerts/Recalls
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