| Lot Number 8RSL051H |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Rheumatoid Arthritis (1724); Erythema (1840); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 11/20/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated 03-dec-2019.This case involved a female patient who 1 day after the injection of synvisc-one developed inflammatory knee similar with acute phase of rheumatoid arthritis.The severely increased lactate concentration in the synovial fluid was initially suggestive of a septic effusion.Further, the findings suggested against a reactive effusion, traumatic effusion and crystal arthritis.A differential diagnosis of acute phase of a rheumatoid arthritis was ascertained by the physician.It was reported that in case the patient experienced further effusion formation, a control examination was recommended.The event was assessed as medically significant.Based on the chronology, the role of synvisc one on the occurrence of the reported adverse event cannot be excluded.Further details on the status of the knee before the injection, technique of injection; indication for which the product was administered, corrective treatments and outcome are deemed necessary for a for proper assessment of this case.
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Event Description
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Inflammation occurred was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis [rheumatoid arthritis].Thick red knee [injection site joint swelling].Thick red knee [injection site joint redness].Strong effusion/knee joint puncture (left) [injection site joint effusion].Case narrative: initial information received on 28-nov-2019 from (b)(6) regarding an unsolicited valid serious case received from a physician.This case involves a (b)(6) years old female patient who experienced inflammation occurred was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis (latency: 1 day), thick red knee (latency: 1 day) (joint swelling and injection site joint erythema) and strong effusion/knee joint puncture (left) (latency: 1 day), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.On an unknown date in 2019, the patient received intra-articular hylan g-f 20, sodium hyaluronate, frequency once (formulation, dose, batch, indication: unknown) (information for batch number was requested).The next day after receiving hylan g-f 20, sodium hyaluronate, patient presented with a thick red knee (latency: 1 day) with strong effusion (latency: 1 day) and her left knee was punctured.The inflammation that occurred was similar to rheumatoid arthritis (latency: 1 day).This event was assessed as medically significant.On (b)(6) 2019, the patient had a knee joint puncture (left) and there was no evidence of bacteria, fungi and obligatory anerobic bacteria.The synovial fluid analysis revealed synovial fluid was bloody tinged, turbid, the viscosity was high, ph was 7.2 (range: 7.31-7.64) (low), leucocytes were 28760/ul (range: <200) (high), histolymphocytes were 10% (range: <75) (low), total protein was 5 g/dl (range: 1.1-2.2) (high), igm were 29 mg/dl (range: 30-140) (low), ldh (lactate dehydrogenase) was 1490 u/l (range: <160) (high), lactate was 122 mg/dl (range: 9-16) (high).The analysis results were assessed to reveal a significantly proliferated cell and inflammation puncture fluid whose cytological image showed a predominant granulocyte portion.The severely increased lactate concentration was initially suggestive of a septic effusion.Further, the findings suggested against a reactive effusion, traumatic effusion and crystal arthritis.A differential diagnosis of acute phase of a rheumatoid arthritis was ascertained by the physician.It was reported that in case the patient experienced further effusion formation, a control examination was recommended.Action taken: not applicable for all events.Corrective treatment: not reported for all events.Outcome: unknown for all events.A product technical complaint was initiated and results were pending for the same.
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Event Description
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Inflammation occurred was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis [rheumatoid arthritis].Thick red knee/redness [injection site joint redness].Thick red knee [injection site joint swelling].Strong effusion/knee joint puncture (left)/massive effusion knee [injection site joint effusion].Overheating [injection site joint warmth].Case narrative: initial information received on 28-nov-2019 from germany regarding an unsolicited valid serious case received from a physician.This case involves a 62 years old male patient who experienced inflammation occurred was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis, thick red knee, thick red knee/redness, strong effusion/knee joint puncture (left)/massive effusion knee and overheating with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient received hylan g-f 20, sodium hyaluronate in knee via intra-articular route once for gonarthrosis (formulation, dose: unknown) (lot number: 8rsl051h; expiration date: jul-2021).On same day, immediately after receiving hylan g-f 20, sodium hyaluronate, the patient presented with a thick red knee (redness) with strong, massive effusion, and overheating.The inflammation that occurred was similar to rheumatoid arthritis (latency: same day).This event was assessed as medically significant (by company).Reportedly, the patient's left knee was punctured twice.On (b)(6) 2019, the patient had a knee joint puncture (left) and there was no evidence of bacteria, fungi and obligatory anerobic bacteria.The synovial fluid analysis revealed synovial fluid was bloody tinged, turbid, the viscosity was high, ph was 7.2 (range: 7.31-7.64) (low), leucocytes were 28760/ul (range: <200) (high), histolymphocytes were 10% (range: <75) (low), total protein was 5 g/dl (range: 1.1-2.2) (high), igm were 29 mg/dl (range: 30-140) (low), ldh (lactate dehydrogenase) was 1490 u/l (range: <160) (high), lactate was 122 mg/dl (range: 9-16) (high).The analysis results were assessed to reveal a significantly proliferated cell and inflammation puncture fluid whose cytological image showed a predominant granulocyte portion.The severely increased lactate concentration was initially suggestive of a septic effusion.Further, the findings suggested against a reactive effusion, traumatic effusion and crystal arthritis.A differential diagnosis of acute phase of a rheumatoid arthritis was ascertained by the physician.It was reported that in case the patient experienced further effusion formation, a control examination was recommended.Reportedly, the suspected septic effusion was not confirmed, and no alternative cause was there that could also explain the clinical symptoms of the suspected adverse event.As of (b)(6) 2020, the patient was recovering from events and still had residual swelling.Action taken: not applicable for all events.Corrective treatment: puncture twice for strong effusion/knee joint puncture (left)/massive effusion knee; ibuprofen (nsaid) for all the events.Outcome: recovering for all the events.A product technical complaint was initiated, and results were pending for the same.Reporter causality: probable for all the events.Additional information was received on 10-jan-2020 from a physician: suspect details (batch, indication) were added.As reported terms were updated to thick red knee, thick red knee/redness, strong effusion/knee joint puncture (left)/massive effusion knee; their outcome updated to recovering and start date was updated to 20-nov-2019.New event of overheating was added.Clinical course updated.Text amended accordingly.
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Event Description
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Inflammation occurred was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis [rheumatoid arthritis] ([injection site joint effusion], [injection site joint warmth], [injection site joint swelling], [injection site joint redness]).Knee joint puncture (left)/left knee was punctured twice [arthrocentesis].Case narrative: initial information received on (b)(6) 2019 from germany regarding an unsolicited valid serious case received from a physician.This case involves a 62 years old male patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and inflammation occurred which was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis and knee joint puncture (left)/left knee was punctured twice.The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient received 48 mg/6 ml synvisc one injection, liquid (solution) in knee via intra-articular route once for gonarthrosis (dose: unknown) (lot number: 8rsl051h; expiration date: 31-jul-2021).On same day, immediately after receiving synvisc one, the patient presented with a thick red knee (redness) (injection site joint erythema, injection site joint swelling) with strong, massive effusion (injection site joint effusion), and overheating (injection site joint warmth).The inflammation that occurred was similar to rheumatoid arthritis (rheumatoid arthritis, latency: same day, event was assessed as medically significant along with seriousness criteria of intervention required).Reportedly, the patient's left knee was punctured twice (aspiration joint, event assessed as serious with seriousness criteria of intervention required).On (b)(6) 2019, the patient had a knee joint puncture (left) and there was no evidence of bacteria, fungi and obligatory anerobic bacteria.The synovial fluid analysis revealed synovial fluid was bloody tinged, turbid, the viscosity was high, ph was 7.2 (range: 7.31-7.64) (low), leucocytes were 28760/ul (range: <200) (high), histolymphocytes were 10% (range: <75) (low), total protein was 5 g/dl (range: 1.1-2.2) (high), igm were 29 mg/dl (range: 30-140) (low), ldh (lactate dehydrogenase) was 1490 u/l (range: <160) (high), lactate was 122 mg/dl (range: 9-16) (high).The analysis results were assessed to reveal a significantly proliferated cell and inflammation puncture fluid whose cytological image showed a predominant granulocyte portion.The severely increased lactate concentration was initially suggestive of a septic effusion.Further, the findings suggested against a reactive effusion, traumatic effusion and crystal arthritis.A differential diagnosis of acute phase of a rheumatoid arthritis was ascertained by the physician.It was reported that in case the patient experienced further effusion formation, a control examination was recommended.Reportedly, the suspected septic effusion was not confirmed, and no alternative cause was there that could also explain the clinical symptoms of the suspected adverse event.As of (b)(6) 2020, the patient was recovering from events and still had residual swelling.Action taken: not applicable for all events.Corrective treatment: puncture twice for injection site joint effusion; ibuprofen (nsaid) for all the events except aspiration joint.Outcome: recovering for all the events.Reporter causality: probable for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2019 for synvisc one for batch number: 8rsl051h and global ptc number: (b)(4).Adverse event reports with or without lot numbers are continuously monitored, and possible associations with their corresponding product lot were assessed, as part of routine safety surveillance effort to detect safety signals.The production and quality control documentation for lot number 7rsp010c was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for the concerned lot number no capa (corrective and preventive action) was required.This review has not indicated any safety issue.As of (b)(6) 2021 there were (b)(4) complaints on file for lot number 8rsl051 and all related sub-lots.(b)(4) complaints were for lot number 8rsl051d: (6) adverse events.(b)(4) complaint was for lot number 8rsl051b: (1) tip breakage.(b)(4) complaint was for lot number 8rsl051h: (1) adverse event report.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation completion date: (b)(6) 2021 additional information was received on 10-jan-2020 from a physician: suspect details (batch, indication) were added.As reported terms were updated to thick red knee, thick red knee/redness, strong effusion/knee joint puncture (left)/massive effusion knee; their outcome updated to recovering and start date was updated to (b)(6) 2019.New event of overheating was added.Clinical course updated.Text amended accordingly.Follow up was received on 28-nov-2019 from healthcare professional.Global ptc number was added.Narrative amended accordingly.Additional information was received on 25-jun-2021 from healthcare professional.Investigational results were added.Narrative amended accordingly.
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Event Description
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Inflammation occurred was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis [rheumatoid arthritis] ([injection site joint effusion], [injection site joint warmth], [injection site joint swelling], [injection site joint redness]) knee joint puncture (left)/left knee was punctured twice [arthrocentesis].Case narrative: initial information received on (b)(6) 2019 from germany regarding an unsolicited valid serious case received from a physician.This case involves a 62 years old male patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and inflammation occurred which was similar to rheumatoid arthritis/acute phase of rheumatoid arthritis and knee joint puncture (left)/left knee was punctured twice.The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient received 48 mg/6 ml synvisc one injection, liquid (solution) in knee via intra-articular route once for gonarthrosis (dose: unknown) (lot number: 8rsl051h; expiration date: 31-jul-2021).On same day, immediately after receiving synvisc one, the patient presented with a thick red knee (redness) (injection site joint erythema, injection site joint swelling) with strong, massive effusion (injection site joint effusion), and overheating (injection site joint warmth).The inflammation that occurred was similar to rheumatoid arthritis (rheumatoid arthritis, latency: same day, event was assessed as medically significant along with seriousness criteria of intervention required).Reportedly, the patient's left knee was punctured twice (aspiration joint, event assessed as serious with seriousness criteria of intervention required).On (b)(6) 2019, the patient had a knee joint puncture (left) and there was no evidence of bacteria, fungi and obligatory anerobic bacteria.The synovial fluid analysis revealed synovial fluid was bloody tinged, turbid, the viscosity was high, ph was 7.2 (range: 7.31-7.64) (low), leucocytes were 28760/ul (range: <200) (high), histolymphocytes were 10% (range: <75) (low), total protein was 5 g/dl (range: 1.1-2.2) (high), igm were 29 mg/dl (range: 30-140) (low), ldh (lactate dehydrogenase) was 1490 u/l (range: <160) (high), lactate was 122 mg/dl (range: 9-16) (high).The analysis results were assessed to reveal a significantly proliferated cell and inflammation puncture fluid whose cytological image showed a predominant granulocyte portion.The severely increased lactate concentration was initially suggestive of a septic effusion.Further, the findings suggested against a reactive effusion, traumatic effusion and crystal arthritis.A differential diagnosis of acute phase of a rheumatoid arthritis was ascertained by the physician.It was reported that in case the patient experienced further effusion formation, a control examination was recommended.Reportedly, the suspected septic effusion was not confirmed, and no alternative cause was there that could also explain the clinical symptoms of the suspected adverse event.As of (b)(6) 2020, the patient was recovering from events and still had residual swelling.Action taken: not applicable for all events.Corrective treatment: puncture twice for injection site joint effusion; ibuprofen (nsaid) for all the events except aspiration joint.Outcome: recovering for all the events.Reporter causality: probable for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2019 for synvisc one for batch number: 8rsl051h and global ptc number: (b)(4).Adverse event reports with or without lot numbers are continuously monitored, and possible associations with their corresponding product lot were assessed, as part of routine safety surveillance effort to detect safety signals.The production and quality control documentation for lot number 8rsl051h was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for the concerned lot number no capa (corrective and preventive action) was required.This review has not indicated any safety issue.As of (b)(6) 2021 there were 8 complaints on file for lot number 8rsl051 and all related sub-lots.6 complaints were for lot number 8rsl051d: (6) adverse events.1 complaint was for lot number 8rsl051b: (1) tip breakage.1 complaint was for lot number 8rsl051h: (1) adverse event report.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation completion date: (b)(6) 2021.Additional information was received on 10-jan-2020 from a physician: suspect details (batch, indication) were added.As reported terms were updated to thick red knee, thick red knee/redness, strong effusion/knee joint puncture (left)/massive effusion knee; their outcome updated to recovering and start date was updated to (b)(6) 2019.New event of overheating was added.Clinical course updated.Text amended accordingly.Follow up was received on 28-nov-2019 from healthcare professional.Global ptc number was added.Narrative amended accordingly.Additional information was received on 25-jun-2021 from healthcare professional.Investigational results were added.Narrative amended accordingly.Based on information previously received, the following information have been amended: analysis of similar incidents was added in the mir form of the case.Ptc description and company comment updated.Narrative amended accordingly.
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