| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 05/06/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated (b)(6)2023: this case involves an unknown age male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).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, 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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Developed post traumatic stress disorder which affects his everyday life and work [post-traumatic stress disorder].Severe infection; knee [joint infection].([injection site joint pain], [injection site joint swelling], [condition aggravated]).Worse pain and issues with his right knee and hip that will likely require further surgeries and procedures [pain in hip].Issues with his right knee and hip that will likely require further surgeries and procedures [arthropathy].Head aches on a regular basis [headache].Case narrative: initial information received on (b)(6) 2023 regarding an unsolicited valid legal case serious case received from a lawyer from canada.This case involves an unknown age male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee, worse pain and issues with his right knee and hip that will likely require further surgeries and procedures, and headaches on a regular basis after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had no medical history, concomitant disease or risk factor.Prior to (b)(6) 2022, doctor had treated the patient with marcaine and depomedrol for knee pain.On (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate injection via intra-articular route (with an unknown batch number, expiry date, dose, frequency, strength) for arthralgia.There will be no information available on the batch number of this case.The reporter stated that doctor injected patient at patient's place of employment which was not a suitable place for such a procedure and the product was not appropriate given how long he had it and how it was obtained.The patient reported to doctor that his knee was immediately began to swell (injection site joint swelling) and he was having severe pain (injection site joint pain) (onset: (b)(6)2022; latency: same day).Doctor negligently kept re-assuring the patient that nothing was wrong until he was finally admitted to hospital on (b)(6) 2022.The patient developed a severe infection (arthritis infective, onset: (b)(6) 2022; latency: few days approximately) from which he nearly died.He underwent several surgeries and was hospitalized for an extended period of time.In addition, he had developed worse pain and issues with his right knee and hip that would likely require further surgeries and medical procedures (arthralgia, arthropathy, condition aggravated) (onset; latency: unknown).He developed post traumatic stress disorder (post-traumatic stress disorder) which affects his everyday life and work, head aches on a regular basis (headache) (onset; latency: unknown).As a result of it the patient injuries, had a significant loss of income and loss of earning capacity, and he had lost some capacity for housekeeping.There were no lab data/results available.Action taken: unknown for all events.Corrective treatment: the patient had several surgeries for arthritis infective and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis infective, disability for post-traumatic stress disorder.
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Event Description
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Developed post traumatic stress disorder which affects his everyday life and work [post-traumatic stress disorder].Severe infection; knee [joint infection] ([injection site joint pain], [injection site joint swelling], [condition aggravated]).Worse pain and issues with his right knee and hip that will likely require further surgeries and procedures [pain in hip].Issues with his right knee and hip that will likely require further surgeries and procedures [arthropathy].Head aches on a regular basis [headache].Case narrative: initial information received on 02-aug-2023 regarding an unsolicited valid legal case serious case received from a lawyer from canada.This case involves an unknown age male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee, worse pain and issues with his right knee and hip that will likely require further surgeries and procedures, and headaches on a regular basis after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, concomitant disease, risk factor, medical treatment(s), vaccination(s) and family history were not provided.Prior to may-2022, doctor had treated the patient with bupivacaine hydrochloride (marcaine) and methylprednisolone acetate(depomedrol ) for knee pain.On 06-may-2022, the patient started using hylan g-f 20, sodium hyaluronate injection via intra-articular route (with strength: 48mg/6ml, an unknown batch number, expiry date, dose, frequency) for arthralgia.There will be no information available on the batch number of this case.The claim alleges that the reporter stated that doctor injected patient at patient's place of employment.The patient reported to doctor that his knee was immediately began to swell (injection site joint swelling) and he was having severe pain (injection site joint pain) (onset: 06-may-2022; latency: same day).The claim alleges that the doctor negligently kept re-assuring the patient that nothing was wrong until he was finally admitted to hospital on 10-may-2022.The patient developed a severe infection (arthritis infective, onset: may-2022; latency: few days approximately) from which he nearly died.He underwent several surgeries and was hospitalized for an extended period of time.In addition, he had developed worse pain and issues with his right knee and hip that would likely require further surgeries and medical procedures (arthralgia, arthropathy, condition aggravated) (onset; latency: unknown).He developed post traumatic stress disorder (post-traumatic stress disorder) which affects his everyday life and work, head aches on a regular basis (headache) (onset; latency: unknown).As a result of it the patient injuries, had a significant loss of income and loss of earning capacity, and he had lost some capacity for housekeeping.There were no lab data/results available.Action taken: unknown for all events.Corrective treatment: the patient had several surgeries for arthritis infective and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis infective, disability for post-traumatic stress disorder.A product technical complaint (ptc) was initiated on 02-aug-2023 for synvisc (batch number: unknown) with global ptc number 100349018.The sample was not available and ptc stated: based on the complaint from intake team, there is 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 - (dp03aug23) investigation: (em 10aug2023) 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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 15-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 02-aug-2023 from healthcare professional (quality department).Ptc global number along with strength were added.Text amended accordingly.Additional information was received on 15-aug-2023 from quality department: ptc details with summarized conclusion added.Text was amended accordingly.
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Event Description
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Developed post traumatic stress disorder which affects his everyday life and work post-traumatic stress disorder severe infection; knee/septic right knee [septic arthritis] ([injection site joint pain], [injection site joint swelling], [condition aggravated]) hematoma right knee with significant discomfort [hematoma] post op pain [post procedural pain] post op constipation [post procedural constipation] worse pain and issues with his right knee and hip that will likely require further surgeries and procedures [pain in hip] issues with his right knee and hip that will likely require further surgeries and procedures [arthropathy] head aches on a regular basis [headache] case narrative: initial information received on (b)(6) 2023 regarding an unsolicited valid legal case serious case received from a lawyer from canada.This case involves 58 years old male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee/septic right knee, worse pain and issues with his right knee and hip that will likely require further surgeries and procedures, hematoma right knee with significant discomfort, post op pain, post op constipation and headaches on a regular basis after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, risk factor, medical treatment(s), vaccination(s) and family history were not provided.Prior to (b)(6) 2022, doctor had treated the patient with bupivacaine hydrochloride (marcaine) and methylprednisolone acetate(depomedrol ) for knee pain.Concurrent conditions included hypertension, crohn's disease, osteoarthritis, rotator cuff surgery and diverticulosis.Since 2003, patient has been smoking (half pack a day).Concomitant medication included bupivacaine (marcaine); methylprednisolone acetate (depo medrol) for arthralgia; amlodipine; perindopril for hypertension; ceftriaxone; sumatriptan and prednisone for crohn's disease on (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 16 mg/2ml via intra-articular route (batch number, expiry date, dose, frequency: unknown) for acute chondromalacia patallae.There will be no information available on the batch number of this case.The claim alleges that the reporter stated that doctor injected patient at patient's place of employment.The patient reported to doctor that his knee was immediately began to swell (injection site joint swelling) and he was having severe pain (injection site joint pain) (onset: 06-may-2022; latency: same day).On (b)(6) 2022, patient came to an outpatient consultation in wheel chair, complaining of severe pain in right knee (no fever or chills).Aspiration of cloudy fluid was done and sent for culture and sepsis was confirmed in right knee (haemophilus parainfluenzae & granulicatella adiacens).The claim alleged that the doctor negligently kept re-assuring the patient that nothing was wrong until he was finally admitted to hospital on the same day.The patient developed a severe infection (arthritis bacterial, onset: 10-may-2022; latency: few days approximately) from which he nearly died.He underwent several surgeries and was hospitalized for an extended period of time.To get the infection under control, during his hospitalization, the patient had to have 2 arthroscopic debridement but due to uncontrolled hypertension, the patient had excessive bleeding with his second surgery as on (b)(6) 2022, patient had hematoma right knee with significant discomfort (latency: 6 days) (haematoma).Once his knee was successfully washed out and the patient was on appropriate antibiotics (ceftriaxone) his infection was trending to the right direction and he was having a good hemostasis and stable hemoglobin at discharge.In addition, he had developed worse pain and issues with his right knee and hip that would likely require further surgeries and medical procedures (arthralgia, arthropathy, condition aggravated) (onset; latency: unknown).He developed post traumatic stress disorder (post-traumatic stress disorder) which affects his everyday life and work, head aches on a regular basis (headache) (onset; latency: unknown).As a result of it the patient injuries, had a significant loss of income and loss of earning capacity, and he had lost some capacity for housekeeping.On (b)(6) 2022, after the latency of 10 days of starting the treatment with synvisc, patient had post op pain (procedural pain) and post op constipation (post procedural constipation) for which patient was given gabapentin, oxycodone hydrochloride, paracetamol, macrogol and sennoside a+b as corrective.Patient subsequently had several follow-up visits in orthopedics.Including on (b)(6) 2022, where the wound on right knee was assessed as healed, healthy, no drainage, no odor and the patient was weight bearing with crutches.Health care professional ordered to remove sutures and staples.Relevant laboratory test results included: aspiration joint - on (b)(6) 2022: [sepsis was confirmed in right knee (haemophilus parainfluenzae & granulicatella adiacens)] blood pressure measurement - on (b)(6) 2022: 145/106 [145/106] body temperature - on (b)(6) 2022: 36.4 [36.4] c-reactive protein - on (b)(6) 2022: 250.2 mg/l [250.2] haematocrit (0.41 - 0.52 l/l) - on (b)(6) 2022: 0.40 l/l [0.40]; on (b)(6)2022: 0.37 l/l [0.37]; on (b)(6) 2022: 0.35 l/l [0.35]; on (b)(6) 2022: 0.35 l/l [0.35] haemoglobin (135 - 175 g/l) - on (b)(6)2022: 133 g/l [133]; on (b)(6) 2022: 121 g/l [121]; on (b) (6) 2022: 111 g/l [111; 13:54: 108; 22:15: 106]; on (b)(6) 2022: 114 g/l [114] monocyte count (0.0 - 0.1 10*9/l) - on (b)(6)2022: 1.3 10*9/l [1.3] neutrophil count (1.8 - 7.5 10*9/l) - on (b)(6)2022: 8.8 10*9/l [8.8]; on b)6) 2022: 12.1 10*9/l [12.1]; on (b)(6) 2022: 13.8 10*9/l [13.8] red blood cell count (4.30 - 6.00 10*12/l) - on (b)(6) 2022: 4.18 10*12/l [4.18]; on (b)(6) 2022: 3.85 10*12/l [3.85]; on (b)(6) 2022: 3.84 10*12/l [3.84] respiratory rate - on (b)(6) 2022: 18 [18] white blood cell count (4.0 - 11.0 10*9/l) - on (b)(6) 2022: 13.6 10*9/l [13.6]; on (b)(6)2022: 13.9 10*9/l [13.9]; on (b)(6) 2022: 19.0 10*9/l [19.0]; on (b)(6) 2022: 16.9 10*9/l [16.9] action taken: unknown for all events.Corrective treatment: the patient had several surgeries arthroscopy right knee for arthritis bacterial, sennoside a+b (senokot), macrogol (lax-a-day) for constipation, gabapentin, oxycodone hydrochloride, paracetamol (percocet) for procedural pain and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis bacterial, disability for post-traumatic stress disorder.A product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample was not available and ptc stated: based on the complaint from intake team, there is 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 - (dp03aug23) investigation: (em 10aug2023) 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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 20-sep-2023 with summarized conclusion as no assessment possible.Additional information was received on 02-aug-2023 from healthcare professional (quality department).Ptc global number along with strength were added.Text amended accordingly.Additional information was received on 15-aug-2023 from quality department: ptc details with summarized conclusion added.Text was amended accordingly.Additional information was received on 12-sep-2023 from the physician.Case became medically confirmed.Additional events of post op pain, hematoma right knee with significant discomfort and post op constipation added.Verbatim for severe infection; knee was updated to severe infection; knee/septic right knee.Concomitant medications added.Lab results added.Clinical course updated and text amended accordingly.Additional information was received on 19-sep-2023 from quality department: strength added; text was amended accordingly.Additional information was received on 20-sep-2023 from the quality department.Ptc results added.Text amended accordingly.
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Event Description
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Developed post traumatic stress disorder which affects his everyday life and work [post-traumatic stress disorder] severe infection; knee/septic right knee [septic arthritis] ([injection site joint pain], [injection site joint swelling], [condition aggravated]) hematoma right knee with significant discomfort [hematoma] post op pain [post procedural pain] post op constipation [post procedural constipation] worse pain and issues with his right knee and hip that will likely require further surgeries and procedures [pain in hip] issues with his right knee and hip that will likely require further surgeries and procedures [arthropathy] head aches on a regular basis [headache] case narrative: initial information received on 02-aug-2023 regarding an unsolicited valid legal case serious case received from a lawyer from canada.This case involves 58 years old male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee/septic right knee, worse pain and issues with his right knee and hip that will likely require further surgeries and procedures, hematoma right knee with significant discomfort, post op pain, post op constipation and headaches on a regular basis after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, risk factor, medical treatment(s), vaccination(s) and family history were not provided.Prior to (b)(6)2022, doctor had treated the patient with bupivacaine hydrochloride (marcaine) and methylprednisolone acetate(depomedrol ) for knee pain.Concurrent conditions included hypertension, crohn's disease, osteoarthritis, rotator cuff surgery and diverticulosis.Since 2003, patient has been smoking (half pack a day).Concomitant medication included bupivacaine (marcaine); methylprednisolone acetate (depo medrol) for arthralgia; amlodipine; perindopril for hypertension; ceftriaxone; sumatriptan and prednisone for crohn's disease on (b)(6)2022, the patient started using hylan g-f 20, sodium hyaluronate injection via intra-articular route (batch number, expiry date, dose, frequency: unknown) for acute chondromalacia patallae.There will be no information available on the batch number of this case.The claim alleges that the reporter stated that doctor injected patient at patient's place of employment.The patient reported to doctor that his knee was immediately began to swell (injection site joint swelling) and he was having severe pain (injection site joint pain) (onset: (b)(6)2022; latency: same day).On (b)(6)2022, patient came to an outpatient consultation in wheel chair, complaining of severe pain in right knee (no fever or chills).Aspiration of cloudy fluid was done and sent for culture and sepsis was confirmed in right knee (haemophilus parainfluenzae & granulicatella adiacens).The claim alleged that the doctor negligently kept re-assuring the patient that nothing was wrong until he was finally admitted to hospital on the same day.The patient developed a severe infection (arthritis bacterial, onset: (b)(6)2022; latency: few days approximately) from which he nearly died.He underwent several surgeries and was hospitalized for an extended period of time.To get the infection under control, during his hospitalization, the patient had to have 2 arthroscopic debridement but due to uncontrolled hypertension, the patient had excessive bleeding with his second surgery as on (b)(6)2022, patient had hematoma right knee with significant discomfort (latency: 6 days) (haematoma).Once his knee was successfully washed out and the patient was on appropriate antibiotics (ceftriaxone) his infection was trending to the right direction and he was having a good hemostasis and stable hemoglobin at discharge.In addition, he had developed worse pain and issues with his right knee and hip that would likely require further surgeries and medical procedures (arthralgia, arthropathy, condition aggravated) (onset; latency: unknown).He developed post traumatic stress disorder (post-traumatic stress disorder) which affects his everyday life and work, head aches on a regular basis (headache) (onset; latency: unknown).As a result of it the patient injuries, had a significant loss of income and loss of earning capacity, and he had lost some capacity for housekeeping.On (b)(6)2022, after the latency of 10 days of starting the treatment with synvisc, patient had post op pain (procedural pain) and post op constipation (post procedural constipation) for which patient was given gabapentin, oxycodone hydrochloride, paracetamol, macrogol and sennoside a+b as corrective.Patient subsequently had several follow-up visits in orthopedics.Including on (b)(6)2022, where the wound on right knee was assessed as healed, healthy, no drainage, no odor and the patient was weight bearing with crutches.Health care professional ordered to remove sutures and staples.Relevant laboratory test results included: aspiration joint - on (b)(6)2022: [sepsis was confirmed in right knee (haemophilus parainfluenzae & granulicatella adiacens)] blood pressure measurement - on (b)(6)2022: 145/106 [145/106] body temperature - on (b)(6)2022: 36.4 [36.4] c-reactive protein - on (b)(6)2022: 250.2 mg/l [250.2] haematocrit (0.41 - 0.52 l/l) - on (b)(6)2022: 0.40 l/l [0.40]; on (b)(6)2022: 0.37 l/l [0.37]; on (b)(6)2022: 0.35 l/l [0.35]; on (b)(6)2022: 0.35 l/l [0.35] haemoglobin (135 - 175 g/l) - on (b)(6)2022: 133 g/l [133]; on (b)(6)2022: 121 g/l [121]; on (b)(6)2022: 111 g/l [111; 13:54: 108; 22:15: 106]; on (b)(6)2022: 114 g/l [114] monocyte count (0.0 - 0.1 10*9/l) - on (b)(6)2022: 1.3 10*9/l [1.3] neutrophil count (1.8 - 7.5 10*9/l) - on (b)(6)2022: 8.8 10*9/l [8.8]; on (b)(6)2022: 12.1 10*9/l [12.1]; on (b)(6)2022: 13.8 10*9/l [13.8] red blood cell count (4.30 - 6.00 10*12/l) - on (b)(6)2022: 4.18 10*12/l [4.18]; on (b)(6)2022: 3.85 10*12/l [3.85]; on (b)(6)2022: 3.84 10*12/l [3.84] respiratory rate - on (b)(6)2022: 18 [18] white blood cell count (4.0 - 11.0 10*9/l) - on (b)(6)2022: 13.6 10*9/l [13.6]; on (b)(6)2022: 13.9 10*9/l [13.9]; on (b)(6)2022: 19.0 10*9/l [19.0]; on (b)(6)2022: 16.9 10*9/l [16.9] action taken: unknown for all events.Corrective treatment: the patient had several surgeries arthroscopy right knee for arthritis bacterial, sennoside a+b (senokot), macrogol (lax-a-day) for constipation, gabapentin, oxycodone hydrochloride, paracetamol (percocet) for procedural pain and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis bacterial, disability for post-traumatic stress disorder.A product technical complaint (ptc) was initiated on (b)(6)2023 for synvisc (batch number: unknown) with global ptc number 100349018.Additional information was received on 02-aug-2023 from healthcare professional (quality department).Ptc global number along with strength were added.Text amended accordingly.Additional information was received on 15-aug-2023 from quality department: ptc details with summarized conclusion added.Text was amended accordingly.Additional information was received on 12-sep-2023 from the physician.Case became medically confirmed.Additional events of post op pain, hematoma right knee with significant discomfort and post op constipation added.Verbatim for severe infection; knee was updated to severe infection; knee/septic right knee.Concomitant medications added.Lab results added.Clinical course updated and text amended accordingly.
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Event Description
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Developed post traumatic stress disorder which affects his everyday life and work [post-traumatic stress disorder].Severe infection; knee/septic right knee [septic arthritis] ([injection site joint pain], [injection site joint swelling], [condition aggravated]).Hematoma right knee with significant discomfort [hematoma].Post op pain [post procedural pain].Post op constipation [post procedural constipation].Worse pain and issues with his right knee and hip that will likely require further surgeries and procedures [pain in hip].Issues with his right knee and hip that will likely require further surgeries and procedures [arthropathy].Head aches on a regular basis [headache].Case narrative: initial information received on 02-aug-2023 regarding an unsolicited valid legal case serious case received from a lawyer from canada.This case involves 58 years old male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee/septic right knee, worse pain and issues with his right knee and hip that will likely require further surgeries and procedures, hematoma right knee with significant discomfort, post op pain, post op constipation and headaches on a regular basis after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, risk factor, medical treatment(s), vaccination(s) and family history were not provided.Prior to (b)(6) 2022, doctor had treated the patient with bupivacaine hydrochloride (marcaine) and methylprednisolone acetate(depomedrol ) for knee pain.Concurrent conditions included hypertension, crohn's disease, osteoarthritis, rotator cuff surgery and diverticulosis.Since 2003, patient has been smoking (half pack a day).Concomitant medication included bupivacaine (marcaine); methylprednisolone acetate (depo medrol) for arthralgia; amlodipine; perindopril for hypertension; ceftriaxone; sumatriptan and prednisone for crohn's disease on (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 16 mg/2ml via intra-articular route (batch number, expiry date, dose, frequency: unknown) for acute chondromalacia patallae.There will be no information available on the batch number of this case.The claim alleges that the reporter stated that doctor injected patient at patient's place of employment.The patient reported to doctor that his knee was immediately began to swell (injection site joint swelling) and he was having severe pain (injection site joint pain) (onset: 06-may-2022; latency: same day).On (b)(6) 2022, patient came to an outpatient consultation in wheel chair, complaining of severe pain in right knee (no fever or chills).Aspiration of cloudy fluid was done and sent for culture and sepsis was confirmed in right knee (haemophilus parainfluenzae & granulicatella adiacens).The claim alleged that the doctor negligently kept re-assuring the patient that nothing was wrong until he was finally admitted to hospital on the same day.The patient developed a severe infection (arthritis bacterial, onset: 10-may-2022; latency: few days approximately) from which he nearly died.He underwent several surgeries and was hospitalized for an extended period of time.To get the infection under control, during his hospitalization, the patient had to have 2 arthroscopic debridement but due to uncontrolled hypertension, the patient had excessive bleeding with his second surgery as on (b)(6) 2022, patient had hematoma right knee with significant discomfort (latency: 6 days) (haematoma).Once his knee was successfully washed out and the patient was on appropriate antibiotics (ceftriaxone) his infection was trending to the right direction and he was having a good hemostasis and stable hemoglobin at discharge.In addition, he had developed worse pain and issues with his right knee and hip that would likely require further surgeries and medical procedures (arthralgia, arthropathy, condition aggravated) (onset; latency: unknown).He developed post traumatic stress disorder (post-traumatic stress disorder) which affects his everyday life and work, head aches on a regular basis (headache) (onset; latency: unknown).As a result of it the patient injuries, had a significant loss of income and loss of earning capacity, and he had lost some capacity for housekeeping.On (b)(6) 2022, after the latency of 10 days of starting the treatment with synvisc, patient had post op pain (procedural pain) and post op constipation (post procedural constipation) for which patient was given gabapentin, oxycodone hydrochloride, paracetamol, macrogol and sennoside a+b as corrective.Patient subsequently had several follow-up visits in orthopedics.Including on (b)(6) 2022, where the wound on right knee was assessed as healed, healthy, no drainage, no odor and the patient was weight bearing with crutches.Health care professional ordered to remove sutures and staples.Relevant laboratory test results included: aspiration joint - on (b)(6) 2022: [sepsis was confirmed in right knee (haemophilus parainfluenzae & granulicatella adiacens)] blood pressure measurement - on (b)(6) 2022: 145/106 [145/106] body temperature - on (b)(6) 2022: 36.4 [36.4] c-reactive protein - on (b)(6) 2022: 250.2 mg/l [250.2] haematocrit (0.41 - 0.52 l/l) - on (b)(6) 2022: 0.40 l/l [0.40]; on 12-may-2022: 0.37 l/l [0.37]; on 13-may-2022: 0.35 l/l [0.35]; on (b)(6) 2022: 0.35 l/l [0.35] haemoglobin (135 - 175 g/l) - on (b)(6) 2022: 133 g/l [133]; on 12-may-2022: 121 g/l [121]; on 13-may-2022: 111 g/l [111; 13:54: 108; 22:15: 106]; on (b)(6) 2022: 114 g/l [114] monocyte count (0.0 - 0.1 10*9/l) - on (b)(6) 2022: 1.3 10*9/l [1.3] neutrophil count (1.8 - 7.5 10*9/l) - on (b)(6) 2022: 8.8 10*9/l [8.8]; on (b)(6) 2022: 12.1 10*9/l [12.1]; on (b)(6) 2022: 13.8 10*9/l [13.8] red blood cell count (4.30 - 6.00 10*12/l) - on (b)(6) 2022: 4.18 10*12/l [4.18]; on (b)(6) 2022: 3.85 10*12/l [3.85]; on (b)(6) 2022: 3.84 10*12/l [3.84] respiratory rate - on (b)(6) 2022: 18 [18] white blood cell count (4.0 - 11.0 10*9/l) - on (b)(6) 2022: 13.6 10*9/l [13.6]; on (b)(6) 2022: 13.9 10*9/l [13.9]; on (b)(6) 2022: 19.0 10*9/l [19.0]; on (b)(6) 2022: 16.9 10*9/l [16.9] action taken: unknown for all events.Corrective treatment: the patient had several surgeries arthroscopy right knee for arthritis bacterial, sennoside a+b (senokot), macrogol (lax-a-day) for constipation, gabapentin, oxycodone hydrochloride, paracetamol (percocet) for procedural pain and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis bacterial, disability for post-traumatic stress disorder.A product technical complaint (ptc) was initiated on 02-aug-2023 for synvisc (batch number: unknown) with global ptc number (b)(4).Additional information was received on 02-aug-2023 from healthcare professional (quality department).Ptc global number along with strength were added.Text amended accordingly.Additional information was received on 15-aug-2023 from quality department: ptc details with summarized conclusion added.Text was amended accordingly.Additional information was received on 12-sep-2023 from the physician.Case became medically confirmed.Additional events of post op pain, hematoma right knee with significant discomfort and post op constipation added.Verbatim for severe infection; knee was updated to severe infection; knee/septic right knee.Concomitant medications added.Lab results added.Clinical course updated and text amended accordingly.Additional information was received on 19-sep-2023 from quality department: strength added; text was amended accordingly.
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Manufacturer Narrative
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Sanofi company comment dated 04-jul-2023: this case involves an unknown age male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).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, 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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Developed post traumatic stress disorder which affects his everyday life and work [post-traumatic stress disorder]; severe infection; knee [joint infection] ([injection site joint pain], [injection site joint swelling], [condition aggravated]); worse pain and issues with his right knee and hip that will likely require further surgeries and procedures [pain in hip]; issues with his right knee and hip that will likely require further surgeries and procedures [arthropathy]; head aches on a regular basis [headache].Case narrative: initial information received on 02-aug-2023 regarding an unsolicited valid legal case serious case received from a lawyer from canada.This case involves an unknown age male patient who developed post traumatic stress disorder which affects his everyday life and work, severe infection; knee, worse pain and issues with his right knee and hip that will likely require further surgeries and procedures, and headaches on a regular basis after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, concomitant disease, risk factor, medical treatment(s), vaccination(s) and family history were not provided.Prior to (b)(6) 2022, doctor had treated the patient with bupivacaine hydrochloride (marcaine) and methylprednisolone acetate(depomedrol ) for knee pain.On (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate injection via intra-articular route (with strength: 48mg/6ml, an unknown batch number, expiry date, dose, frequency) for arthralgia.There will be no information available on the batch number of this case.The reporter stated that doctor injected patient at patient's place of employment which was not a suitable place for such a procedure and the product was not appropriate given how long he had it and how it was obtained.The patient reported to doctor that his knee was immediately began to swell (injection site joint swelling) and he was having severe pain (injection site joint pain) (onset: (b)(6) 2022; latency: same day).Doctor negligently kept re-assuring the patient that nothing was wrong until he was finally admitted to hospital on (b)(6) 2022.The patient developed a severe infection (arthritis infective, onset: (b)(6) 2022; latency: few days approximately) from which he nearly died.He underwent several surgeries and was hospitalized for an extended period of time.In addition, he had developed worse pain and issues with his right knee and hip that would likely require further surgeries and medical procedures (arthralgia, arthropathy, condition aggravated) (onset; latency: unknown).He developed post traumatic stress disorder (post-traumatic stress disorder) which affects his everyday life and work, head aches on a regular basis (headache) (onset; latency: unknown).As a result of it the patient injuries, had a significant loss of income and loss of earning capacity, and he had lost some capacity for housekeeping.There were no lab data/results available.Action taken: unknown for all events.Corrective treatment: the patient had several surgeries for arthritis infective and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis infective, disability for post-traumatic stress disorder.A product technical complaint (ptc) was initiated on 02-aug-2023 for synvisc (batch number: unknown) with global ptc number 100349018.The sample status was not available.Ptc was set in process and results were pending for the same.Additional information was received on 02-aug-2023 from healthcare professional (quality department).Ptc global number along with strength were added.Text amended accordingly.
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Search Alerts/Recalls
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