| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Unspecified Infection (1930); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Movement Disorder (4412)
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| Event Date 01/01/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment 04-apr-2023.This case involves a 40 years old female patient who experienced knee joint severely inflamed, almost immobile, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one], which occurred after unknown latency.The event resulted in disability as the patient had to use crutches.Patient had underlying history of osteoarthritis which could be a confounding factor.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the details of the reaction course, patients underlying disease conditions, past drug history and concomitant medications.
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Event Description
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Knee joint severely inflamed, almost immobile [joint inflammation].([mobility decreased], [injection site joint swelling], [injection site joint warmth], [injection site joint discomfort], [joint range of motion decreased]).Synvisc one via subcutaneous route with no reported adverse event [incorrect route of product administration].Case narrative: initial information received on 29-mar-2023 regarding an unsolicited valid serious case received from other health professional from germany.This case involves a 40 years old female patient who experienced knee joint severely inflamed, almost immobile, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route with no reported adverse event.The patient's past medical history included lung embolism in 2013.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi 44.08.Patient had no allergies.On an unknown date in 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection once via subcutaneous route (incorrect route of product administration) (same day) (batch, expiration date, strength: unknown) for osteoarthritis in the knee (both sides).Patient had a very strong and unexpected reaction to a knee injection with synvisc one.On (b)(6) 2020, after unknown latency, patients knee joint severely inflamed, almost immobile (arthritis and mobility decreased).Initially expected discomfort at the injection (injection site joint discomfort) (onset: 2020 and latency: unknown), then heat build-up in the knee, swelling (injection site joint warmth and injection site joint swelling) (onset: 2020 and latency: unknown) countermeasures (example: cooling, elevation, anti-inflammatory ointments).Complaints worsen until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased) (onset: 2020 and latency: unknown).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.Action taken: not applicable for both events.Corrective treatment: cooling, elevation, anti-inflammatory ointments, crutches for arthritis.Outcome: not recovered/not resolved for arthritis; unknown for incorrect route of product administration.Seriousness criterion: disability for arthritis.A product technical complaint was initiated and results were pending for the same.
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Manufacturer Narrative
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Sanofi company comment 04-apr-2023.This case involves a 40 years old female patient who experienced knee joint severely inflamed, almost immobile, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one], which occurred after unknown latency.The event resulted in disability as the patient had to use crutches.Patient had underlying history of osteoarthritis which could be a confounding factor.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the details of the reaction course, patients underlying disease conditions, past drug history and concomitant medications.
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Event Description
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Knee joint severely inflamed, almost immobile [joint inflammation] ([mobility decreased], [injection site joint swelling], [injection site joint warmth], [injection site joint discomfort], [joint range of motion decreased]).Synvisc one via subcutaneous route with no reported adverse event [incorrect route of product administration].Case narrative: initial information received on 29-mar-2023 regarding an unsolicited valid serious case received from consumer/non-hcp from germany (via health authority).This case involves a 40 years old female patient whose knee joint severely inflamed, almost immobile, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route with no reported adverse event.The patient's past medical history included lung embolism in 2013.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi 44.08.Patient had no allergies.On an unknown date in 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection once via subcutaneous route (incorrect route of product administration) (same day) (batch number, dose, expiration date, strength: unknown) for osteoarthritis in the knee (both sides).Patient had a very strong and unexpected reaction to a knee injection with synvisc one.On (b)(6) 2020, after unknown latency, patients knee joint severely inflamed, almost immobile (arthritis and mobility decreased).Initially expected discomfort at the injection (injection site joint discomfort) (onset: 2020 and latency: unknown), then heat build-up in the knee, swelling (injection site joint warmth and injection site joint swelling) (onset: 2020 and latency: unknown) countermeasures (example: cooling, elevation, anti-inflammatory ointments).Complaints worsen until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased) (onset: 2020 and latency: unknown).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.Action taken: not applicable for both events.Corrective treatment: cooling, elevation, anti-inflammatory ointments, crutches for arthritis.Outcome: not recovered/not resolved for arthritis; unknown for incorrect route of product administration.Seriousness criterion: disability for arthritis.A product technical complaint was initiated and results were pending for the same.Based on the information previously received, the date of incident was captured in the section 1.2 (b) of the mir form.Text amended accordingly.Based on information previously received, the following information have been amended: section what further investigations do you intend in view of reaching final conclusion? in section 4.1(c) of mir form and what is the current location of the device? 3.2 (c) was updated.Text amended accordingly.Based on information previously received, field "does the incident represent serious public threat" has been updated to no under eu/ca form.Reporter type has been updated from other healthcare professional to non-healthcare professional.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible [joint range of motion decreased] almost immobile [mobility decreased] knee joint severely inflamed, almost immobile [injection site joint inflammation] ([condition aggravated], [injection site joint swelling], [injection site joint discomfort], [injection site joint warmth]) knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) synvisc one via subcutaneous route with no reported adverse event [incorrect route of product administration] case narrative: initial information received on 29-mar-2023 regarding an unsolicited valid serious case received from consumer/non-hcp from germany (via health authority).This case involves a 40 years old female patient whose knee joint severely inflamed, almost immobile, knee is worse than before the treatment, moving without crutches was no longer possible, knee joint severely inflamed, almost immobile, synvisc one via subcutaneous route with no reported adverse event and knee can still not be loaded as before or as hoped for after the treatment while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included pulmonary embolism in 2013.The patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi 44.08.Patient had no allergies.On an unknown date in 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection once via subcutaneous route (incorrect route of product administration) (same day) (batch number, dose, expiration date, strength: unknown) for osteoarthritis in the knee (both sides).Information regarding batch number was requested.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.On 01-may-2020, after unknown latency, patients knee joint severely inflamed, almost immobile (injection site joint inflammation and mobility decreased).Initially expected discomfort at the injection (injection site joint discomfort) (onset: 2020 and latency: unknown), then heat build-up in the knee, swelling (injection site joint warmth and injection site joint swelling) (onset: 2020 and latency: unknown) countermeasures (example: cooling, elevation, anti-inflammatory ointments).Complaints worsen until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased) (onset: 2020 and latency: unknown).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.The knee can still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee is worse than before the treatment - this concerns, as described, both treated knees (also from the treatment before) (osteoarthritis; seriousness criteria: medically significant) (device ineffective).Action taken: not applicable for all the events corrective treatment: zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren [diclofenac]) for injection site joint swelling.Outcome: unknown for the events osteoarthritis and incorrect route of product administration; recovering for injection site joint inflammation.Seriousness criteria: disability for the event arthritis.A product technical complaint (ptc) was initiated on 29-mar-2023 for synvisc one, batch number and expiry date: unknown with global ptc number: (b)(4).The investigation is in process and sample status is set to not available.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Based on the information previously received, the date of incident was captured in the section 1.2 (b) of the mir form.Text amended accordingly.Based on information previously received, the following information have been amended: section what further investigations do you intend in view of reaching final conclusion? in section 4.1(c) of mir form and what is the current location of the device? 3.2 (c) was updated.Text amended accordingly.Based on information previously received, field "does the incident represent serious public threat" has been updated to no under eu/ca form.Reporter type has been updated from other healthcare professional to non-healthcare professional.Based on information previously received, reporter updated in general tab from non-hcp to patient (as a result of which role of initial reporter was updated in the section 3.4 (a) of the mir form from other to patient) to generate reports.Additional information was received on 07-may-2023: the event osteoarthritis was added.The corrective treatment was added.Clinical course was updated and text amended accordingly.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) knee joint severely inflamed [injection site joint inflammation] ([condition aggravated], [injection site joint swelling], [injection site joint discomfort], [injection site joint warmth]) synvisc one via subcutaneous route with no reported adverse event [incorrect route of product administration] case narrative: this case is linked to case (b)(4) (multiple devices suspect for same patient, case for injection on (b)(6) 2023) initial information was received on 29-mar-2023 regarding an unsolicited valid serious case from patient from germany (via health authority).This case involves a 40 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, almost immobile, knee joint severely inflamed, almost immobile, knee is worse than before the treatment after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route (with no reported adverse event) the patient's past medical history included pulmonary embolism since 2013 (about 10 years ago) the patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi 44.08.Patient had no allergies.On an unknown date in 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, 48 mg/6ml) injection once via subcutaneous route (incorrect route of product administration) (same day) (batch number, dose, expiration date: unknown) for osteoarthritis in the knee (both sides).Information regarding batch number was requested.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.On (b)(6) 2020, after unknown latency, patients knee joint severely inflamed, almost immobile (injection site joint inflammation and mobility decreased, caused disability).Initially expected discomfort at the injection (injection site joint discomfort, caused disability) (onset: 2020 and latency: unknown), then heat build-up in the knee, swelling (injection site joint warmth and injection site joint swelling, caused disability) (onset: 2020 and latency: unknown) countermeasures (example: cooling, elevation, anti-inflammatory ointments).Complaints worsen until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased, caused disability) (onset: 2020 and latency: unknown).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020), now again (in 2023) - similar reaction on the other knee.There are no indications in the side effects that describe such a course.The knee can still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee is worse than before the treatment - this concerns, as described, both treated knees (also from the treatment before) (osteoarthritis; seriousness criteria: medically significant) (device ineffective).Action taken: not applicable for all the events.Corrective treatment: zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren) for knee joint severely inflamed, used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation, not reported for osteoarthritis.At time of reporting, the outcome was recovered on an unknown date for the event complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, was recovering for the event knee joint severely inflamed, was unknown for the event synvisc one via subcutaneous route with no reported adverse event, was recovered on an unknown date for the event almost immobile and was not recovered for the event knee is worse than before the treatment.A product technical complaint (ptc) was initiated on 29-mar-2023 for synvisc one, batch number and expiry date: unknown with global ptc number: 100325419.Sample of the ptc was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint did not have a quality defect that would attribute to 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.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was 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 action and preventive action) is required.The final investigation was completed on 22-may-2023 with summarized conclusion as no assessment possible.Based on the information previously received, the date of incident was captured in the section 1.2 (b) of the mir form.Text amended accordingly.Based on information previously received, the following information have been amended: section what further investigations do you intend in view of reaching final conclusion? in section 4.1(c) of mir form and what is the current location of the device? 3.2 (c) was updated.Text amended accordingly.Based on information previously received, field "does the incident represent serious public threat" has been updated to no under eu/ca form.Reporter type has been updated from other healthcare professional to non-healthcare professional.Based on information previously received, reporter updated in general tab from non-hcp to patient (as a result of which role of initial reporter was updated in the section 3.4 (a) of the mir form from other to patient) to generate reports.Additional information was received on 07-may-2023 from other healthcare professional: the event osteoarthritis was added.The corrective treatment was added.Clinical course was updated, and text amended accordingly.Additional information was received on 22-may-2023 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, the case became medically confirmed.Text was amended accordingly.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/extension/flexion 0-0-40/extension/flexion 0-0-110 [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) suspicion of joint infection of right knee joint [joint infection] grade iv chondromalacia of the right knee joint [chondromalacia] medial meniscus tear on the right side grade iv [meniscus tear] knee joint severely inflamed, suspicion of an inflammatory process [injection site joint inflammation] ([injection site joint pain], [injection site joint warmth], [injection site joint effusion], [condition aggravated], [injection site joint swelling], [injection site joint discomfort]) chronic pain syndrome of the lumbar vertebral column [lumbar pain syndrome] case narrative: initial information was received from germany on 29-mar-2023 regarding an unsolicited valid serious case from patient (via health authority).This case is linked to case 2023sa148375 (multiple devices suspect for same patient, case for injection on (b)(6) 2023) this case involves a 40 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/extension/flexion 0-0-40/extension/flexion 0-0-110, almost immobile, knee is worse than before the treatment, suspicion of joint infection of right knee joint, grade iv chondromalacia of the right knee joint, medial meniscus tear on the right side grade iv, knee joint severely inflamed, suspicion of an inflammatory process, and chronic pain syndrome of the lumbar vertebral column after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included pulmonary embolism since 2013 (about 10 years ago) and thyroid disorder.The patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing hypertension, coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi(body mass index) 44.08.Patient had no allergies.Patient was having synvisc one injection once yearly and took it in (b)(6) 2018 and in (b)(6) 2019 in right knee.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, strength: 48 mg/6ml) injection in right knee once (yearly) via intra-articular route (batch number, dose, expiration date: unknown) for osteoarthritis in the knee (both sides).There will be no information available on the batch number of this case.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.There was significant increase in symptoms after injection.The patient reportedly developed increasing pain (injection site joint pain, onset date: apr-2020, latency: few days) after the infiltration on (b)(6) 2020 (synvisc one).It was said to have been swollen, overheated and inflamed.Only visited the out-patient emergency.The patient's knee joint was severely inflamed (injection site joint inflammation, onset date: apr-2020, latency: few days), almost immobile (mobility decreased, onset date: apr-2020, latency: few days).Initially expected discomfort at the injection (injection site joint discomfort) (onset: apr-2020, latency: few days), then heat build-up in the knee, swelling (injection site joint warmth and injection site joint swelling, onset: apr-2020, latency: few days) countermeasures (example: cooling, elevation, anti-inflammatory ointments, antibiotics, tilidin, ibu) (ibuprofen).Complaints worsen until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased) (onset: 20-apr-2020 and latency: 3 days).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020).On clinical examination of right knee joint on (b)(6) 2020: normal relief, no articular effusion, no external signs of inflammation were noted.Clinically no signs of thrombosis were noted.Extent of movement: extension/flexion 0-0-40 degree, no ligament instability noted.Pain on forced extension and flexion was there (injection site joint pain).Tenderness on pressure, intra-articular space medial and pes anserinus (goose foot) as well as in the region of the upper recessus.Gonarthrosis on both sides and suspicion of an inflammatory process was diagnosed.The patient was recommended to undergo a laboratory chemical examination to rule out any infections; application of mono embolex ready to use syringe and discharge with at-ready to use syringes, oral pain medication and underarm crutches for partial relief of the knee joint.An mri (magnetic resonance imaging) examination of the right knee joint was to be done and patient was requested to present again at appointment clinic in two days to plan the next procedure.A corresponding transfer to the radiology department was handed over.On 22-apr-2020, patient presented again for monitoring the findings of the laboratory chemical tests.There was suspicion of joint infection of the right knee joint (arthritis infective, onset: 22-apr-2020, latency: 5 days).On clinical examination of right knee joint on (b)(6) 2020: normal relief, no intra-articular effusion was noted.No reddening, no overheating was there.Extent of movement: extension/flexion 0-0-110, no ligament instability noted.There was pain on forced extension and flexion.There was tenderness on pressure.Intra-articular space medial and pes anserinus (goose foot).Gonarthrosis on both sides, suspicion of inflammatory process and chronic pain syndrome of the lumbar vertebral column (back pain, onset date: 22-apr-2020, latency: 5 days) was diagnosed.The patient was given antibiotic coverage over five days, to have physical rest and local cooling measures.On (b)(6) 2020, patient presented again after mri examination.Checkup of blood parameters (minor blood panel and crp (c-reactive protein)) was done.The prescription for 10 times at-ready to use syringes.6 times kg (full form not provided) was prescribed.Extension of the au(full form not provided) till (b)(6) 2020 was done.Gonarthrosis on both sides; suspicion of an inflammatory process was diagnosed.Mri of right knee joint on (b)(6) 2020 was done and grade iv medial meniscus tear (meniscus injury, onset date: (b)(6) 2020, latency: 11 days) and grade iv medial chondromalacia (chondromalacia, onset date: 28-apr-2020, latency: 11 days) were diagnosed.Prescription for 10x at-ready to use syringes and tilidin tablets 100/8mg.6 x kg prescribed.Extension of the au (antibiotic use) till (b)(6) 2020 was done.On (b)(6) 2020, the patient could walk again without crutches, but would still be preferable to use a support for walking.On the whole she described a 60-70% improvement.On examination of right knee joint: grouty relief, clear intra-articular effusion (injection site joint effusion, onset date: 13-may-2020, latency: 27 days).Extent of movement: extension/flexion 0-0-110, no ligament instability.Pain on forced extension and flexion.Tenderness on palpation (injection site joint pain) intra-articular space and pes anserinus (goose foot).Left knee joint: normal relief, no intra-articular effusion.Extent of movement: extension/flexion 0-0-120, no ligament instability.Pain on forced extension and flexion.Pressure pain.Intra-articular space and pes anserinus (goose foot).A medial meniscus tear on the right side; grade iv chondromalacia of the right knee joint; gonarthrosis on both sides was diagnosed.A detailed counseling of the patient was done.Issue of an au for the next 14 days.If severe complaints recur, the patient was requested to present again at consultation clinic.The knee could still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition was currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee was worse than before the treatment - this concerned, as described, both treated knees (also from the treatment before) (osteoarthritis and device ineffective; onset date: 2020, latency: few weeks).The patient again had similar reaction on the other knee in 2023.As per physician, there were no indications in the side effects that describe such a course.Relevant laboratory test results included: c-reactive protein - on (b)(6) 2020: 55.3 mg/l [<5.00]; on 30-apr-2020 12.3 mg/l [<5.00] haematocrit (36 - 47 %) - on (b)(6) 2020: 46 %; on (b)(6) 2020: 47 % haemoglobin (12.0 - 16.0 g/dl) - on (b)(6) 2020: 14.6 g/dl; on (b)(6) 2020: 14.5 g/dl magnetic resonance imaging - on (b)(6) 2020: [grade iv medial meniscus tear, grade iv medial chondromalacia] mean cell haemoglobin (28.0 - 34.0 pg) - on (b)(6) 2020: 27.9 pg; on (b)(6) 2020: 27.1 pg mean cell haemoglobin concentration (32.0 - 36.0 g/dl) - on (b)(6) 2020: 31.8 g/dl; on (b)(6) 2020: 31.2 g/dl mean cell volume (81 - 100 fl) - on (b)(6) 2020: 88 fl; on (b)(6) 2020: 87 fl platelet count (150 - 440 10*3/ul) - on (b)(6) 2020: 356 10*3/ul; on (b)(6) 2020 407 10*3/ul red blood cell count (3.90 - 5.30 10*6/ul) - on (b)(6) 2020: 5.23 10*6/ul; on (b)(6) 2020: 5.35 10*6/ul ultrasound joint - on (b)(6) 2020: [narrow margin of fluid in upper recess.Otherwise unremarkable findings.] white blood cell count (4.00 - 11.0 10*3) - on (b)(6) 2020: 14.7 10*3; on (b)(6) 2020: 10.8 10*3 action taken: not applicable for all the events corrective treatment: prescription for 10x at-ready to use syringes, 6 x kg prescribed for chondromalacia and meniscus injury.Extension of the au till (b)(6) 2020; ibuprofen, zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren) for injection site joint inflammation; used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation,chondromalacia and meniscus injury; certoparin sodium (mono embolex), at-ready to use syringes, oral pain medication, underarm crutches and naloxone hydrochloride, tilidine hydrochloride (tilidin) for injection site joint inflammation, chondromalacia and meniscus injury; not reported for osteoarthritis and back pain at time of reporting, the outcome was recovered in 2020 for the event joint range of motion decreased, mobility decreased.Recovering for the event chondromalacia, meniscus injury, injection site joint inflammation, and arthritis infective; not recovered for osteoarthritis, back pain seriousness criteria: disability for joint range of motion decreased, mobility decreased, chondromalacia, meniscus injury, and injection site joint inflammation, medically significant for arthritis infective and osteoarthritis a product technical complaint (ptc) was initiated on 29-mar-2023 for synvisc one, batch number and expiry date: unknown with global ptc number: 100325419.Sample of the ptc was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint did not have a quality defect that would attribute to 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.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was 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 action and preventive action) is required.The final investigation was completed on 22-may-2023 with summarized conclusion as no assessment possible.The complaint (b)(4) has been reopened for the following reason: wrong complaint information based on the information previously received, the date of incident was captured in the section 1.2 (b) of the mir form.Text amended accordingly.Based on information previously received, the following information have been amended: section what further investigations do you intend in view of reaching final conclusion? in section 4.1(c) of mir form and what is the current location of the device? 3.2 (c) was updated.Text amended accordingly.Based on information previously received, field "does the incident represent serious public threat" has been updated to no under eu/ca form.Reporter type has been updated from other healthcare professional to non-healthcare professional.Based on information previously received, reporter updated in general tab from non-hcp to patient (as a result of which role of initial reporter was updated in the section 3.4 (a) of the mir form from other to patient) to generate reports.Additional information was received on 07-may-2023 from other healthcare professional: the event osteoarthritis was added.The corrective treatment was added.Clinical course was updated, and text amended accordingly.Additional information was received on 22-may-2023 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, the case became medically confirmed.Text was amended accordingly.Follow up information was received on 30-may-2023 from quality department: reopening of ptc details added.No significant information received.Additional information was received on 31-may-2023 from physician: new events added: arthritis infective, chondromalacia, meniscus injury, back pain and injection site joint effusion.As reported verbatim and start date for event joint range of motion decreased updated.Event of incorrect route of product administration was deleted.Therapy start date was updated to (b)(6) 2020, route of administration was updated from subcutaneous to intra-articular.Relevant lab data was added.Medical history of thyroid disorder added.Concurrent condition oof hypertension added.Corrective treatments were added.Clinical course was updated and text was amended.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/extension/flexion 0-0-40/extension/flexion 0-0-110 [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) suspicion of joint infection of right knee joint [joint infection] grade iv chondromalacia of the right knee joint [chondromalacia] medial meniscus tear on the right side grade iv [meniscus tear] knee joint severely inflamed, suspicion of an inflammatory process [injection site joint inflammation] ([injection site joint pain], [injection site joint warmth], [injection site joint effusion], [condition aggravated], [injection site joint swelling], [injection site joint discomfort]) chronic pain syndrome of the lumbar vertebral column [lumbar pain syndrome] case narrative: initial information was received from germany on 29-mar-2023 regarding an unsolicited valid serious case from patient (via health authority).This case is linked to case (b)(4) (multiple devices suspect for same patient, case for injection on (b)(6) 2023) this case involves a 40 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/extension/flexion 0-0-40/extension/flexion 0-0-110, almost immobile, knee is worse than before the treatment, suspicion of joint infection of right knee joint, grade iv chondromalacia of the right knee joint, medial meniscus tear on the right side grade iv, knee joint severely inflamed, suspicion of an inflammatory process, and chronic pain syndrome of the lumbar vertebral column after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included pulmonary embolism since 2013 (about 10 years ago) and thyroid disorder.The patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing hypertension, coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi(body mass index) 44.08.Patient had no allergies.Patient was having synvisc one injection once yearly and took it in feb-2018 and in apr-2019 in right knee.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, strength: 48 mg/6ml) injection in right knee once (yearly) via intra-articular route (batch number, dose, expiration date: unknown) for osteoarthritis in the knee (both sides).There will be no information available on the batch number of this case.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.There was significant increase in symptoms after injection.The patient reportedly developed increasing pain (injection site joint pain, onset date: apr-2020, latency: few days) after the infiltration on (b)(6) 2020 (synvisc one).It was said to have been swollen, overheated and inflamed.Only visited the out-patient emergency.The patient's knee joint was severely inflamed (injection site joint inflammation, onset date: apr-2020, latency: few days), almost immobile (mobility decreased, onset date: apr-2020, latency: few days).Initially expected discomfort at the injection (injection site joint discomfort) (onset: apr-2020, latency: few days), then heat build-up in the knee, swelling (injection site joint warmth and injection site joint swelling, onset: apr-2020, latency: few days) countermeasures (example: cooling, elevation, anti-inflammatory ointments, antibiotics, tilidin, ibu) (ibuprofen).Complaints worsen until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased) (onset: (b)(6) 2020 and latency: 3 days).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020).On clinical examination of right knee joint on (b)(6) 2020: normal relief, no articular effusion, no external signs of inflammation were noted.Clinically no signs of thrombosis were noted.Extent of movement: extension/flexion 0-0-40 degree, no ligament instability noted.Pain on forced extension and flexion was there (injection site joint pain).Tenderness on pressure, intra-articular space medial and pes anserinus (goose foot) as well as in the region of the upper recessus.Gonarthrosis on both sides and suspicion of an inflammatory process was diagnosed.The patient was recommended to undergo a laboratory chemical examination to rule out any infections; application of mono embolex ready to use syringe and discharge with at-ready to use syringes, oral pain medication and underarm crutches for partial relief of the knee joint.An mri (magnetic resonance imaging) examination of the right knee joint was to be done and patient was requested to present again at appointment clinic in two days to plan the next procedure.A corresponding transfer to the radiology department was handed over.On (b)(6) 2020, patient presented again for monitoring the findings of the laboratory chemical tests.There was suspicion of joint infection of the right knee joint (arthritis infective, onset: (b)(6) 2020, latency: 5 days).On clinical examination of right knee joint on (b)(6) 2020: normal relief, no intra-articular effusion was noted.No reddening, no overheating was there.Extent of movement: extension/flexion 0-0-110, no ligament instability noted.There was pain on forced extension and flexion.There was tenderness on pressure.Intra-articular space medial and pes anserinus (goose foot).Gonarthrosis on both sides, suspicion of inflammatory process and chronic pain syndrome of the lumbar vertebral column (back pain, onset date: (b)(6) 2020, latency: 5 days) was diagnosed.The patient was given antibiotic coverage over five days, to have physical rest and local cooling measures.On (b)(6) 2020, patient presented again after mri examination.Checkup of blood parameters (minor blood panel and crp (c-reactive protein)) was done.The prescription for 10 times at-ready to use syringes.6 times kg (full form not provided) was prescribed.Extension of the au(full form not provided) till (b)(6) 2020 was done.Gonarthrosis on both sides; suspicion of an inflammatory process was diagnosed.Mri of right knee joint on (b)(6) 2020 was done and grade iv medial meniscus tear (meniscus injury, onset date: (b)(6) 2020, latency: 11 days) and grade iv medial chondromalacia (chondromalacia, onset date: (b)(6) 2020, latency: 11 days) were diagnosed.Prescription for 10x at-ready to use syringes and tilidin tablets 100/8mg.6 x kg prescribed.Extension of the au (antibiotic use) till 17-may-2020 was done.On (b)(6) 2020, the patient could walk again without crutches, but would still be preferable to use a support for walking.On the whole she described a 60-70% improvement.On examination of right knee joint: grouty relief, clear intra-articular effusion (injection site joint effusion, onset date: (b)(6) 2020, latency: 27 days).Extent of movement: extension/flexion 0-0-110, no ligament instability.Pain on forced extension and flexion.Tenderness on palpation (injection site joint pain) intra-articular space and pes anserinus (goose foot).Left knee joint: normal relief, no intra-articular effusion.Extent of movement: extension/flexion 0-0-120, no ligament instability.Pain on forced extension and flexion.Pressure pain.Intra-articular space and pes anserinus (goose foot).A medial meniscus tear on the right side; grade iv chondromalacia of the right knee joint; gonarthrosis on both sides was diagnosed.A detailed counseling of the patient was done.Issue of an au for the next 14 days.If severe complaints recur, the patient was requested to present again at consultation clinic.The knee could still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition was currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee was worse than before the treatment - this concerned, as described, both treated knees (also from the treatment before) (osteoarthritis and device ineffective; onset date: 2020, latency: few weeks).The patient again had similar reaction on the other knee in 2023.As per physician, there were no indications in the side effects that describe such a course.Relevant laboratory test results included: c-reactive protein - on (b)(6) 2020: 55.3 mg/l [<5.00]; on (b)(6) 2020 12.3 mg/l [<5.00] haematocrit (36 - 47 %) - on (b)(6) 2020: 46 %; on (b)(6) 2020: 47 % haemoglobin (12.0 - 16.0 g/dl) - on (b)(6) 2020: 14.6 g/dl; on (b)(6) 2020: 14.5 g/dl magnetic resonance imaging - on (b)(6) 2020: [grade iv medial meniscus tear, grade iv medial chondromalacia] mean cell haemoglobin (28.0 - 34.0 pg) - on (b)(6) 2020: 27.9 pg; on (b)(6) 2020: 27.1 pg mean cell haemoglobin concentration (32.0 - 36.0 g/dl) - on (b)(6) 2020: 31.8 g/dl; on 30-apr-2020: 31.2 g/dl mean cell volume (81 - 100 fl) - on (b)(6) 2020: 88 fl; on (b)(6) 2020: 87 fl platelet count (150 - 440 10*3/ul) - on (b)(6) 2020: 356 10*3/ul; on (b)(6) 2020 407 10*3/ul red blood cell count (3.90 - 5.30 10*6/ul) - on (b)(6) 2020: 5.23 10*6/ul; on (b)(6) 2020: 5.35 10*6/ul ultrasound joint - on (b)(6) 2020: [narrow margin of fluid in upper recess.Otherwise unremarkable findings.] white blood cell count (4.00 - 11.0 10*3) - on (b)(6) 2020: 14.7 10*3; on (b)(6) 2020: 10.8 10*3 action taken: not applicable for all the events corrective treatment: prescription for 10x at-ready to use syringes, 6 x kg prescribed for chondromalacia and meniscus injury.Extension of the au till (b)(6) 2020; ibuprofen, zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren) for injection site joint inflammation; used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation,chondromalacia and meniscus injury; certoparin sodium (mono embolex), at-ready to use syringes, oral pain medication, underarm crutches and naloxone hydrochloride, tilidine hydrochloride (tilidin) for injection site joint inflammation, chondromalacia and meniscus injury; not reported for osteoarthritis and back pain at time of reporting, the outcome was recovered in 2020 for the event joint range of motion decreased, mobility decreased.Recovering for the event chondromalacia, meniscus injury, injection site joint inflammation, and arthritis infective; not recovered for osteoarthritis, back pain seriousness criteria: disability for joint range of motion decreased, mobility decreased, chondromalacia, meniscus injury, and injection site joint inflammation, medically significant for arthritis infective and osteoarthritis a product technical complaint (ptc) was initiated on 29-mar-2023 for synvisc one, batch number and expiry date: unknown with global ptc number: 100325419.Sample of the ptc was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint did not have a quality defect that would attribute to 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.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was 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 action and preventive action) is required.The final investigation was completed on 22-may-2023 with summarized conclusion as no assessment possible.The complaint (b)(4) has been reopened for the following reason: wrong complaint information based on the information previously received, the date of incident was captured in the section 1.2 (b) of the mir form.Text amended accordingly.Based on information previously received, the following information have been amended: section what further investigations do you intend in view of reaching final conclusion? in section 4.1(c) of mir form and what is the current location of the device? 3.2 (c) was updated.Text amended accordingly.Based on information previously received, field "does the incident represent serious public threat" has been updated to no under eu/ca form.Reporter type has been updated from other healthcare professional to non-healthcare professional.Based on information previously received, reporter updated in general tab from non-hcp to patient (as a result of which role of initial reporter was updated in the section 3.4 (a) of the mir form from other to patient) to generate reports.Additional information was received on 07-may-2023 from other healthcare professional: the event osteoarthritis was added.The corrective treatment was added.Clinical course was updated, and text amended accordingly.Additional information was received on 22-may-2023 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, the case became medically confirmed.Text was amended accordingly.Follow up information was received on 22-may-2023 from quality department: reopening of ptc details added.No significant information received.Additional information was received on 31-may-2023 from physician: new events added: arthritis infective, chondromalacia, meniscus injury, back pain and injection site joint effusion.As reported verbatim and start date for event joint range of motion decreased updated.Event of incorrect route of product administration was deleted.Therapy start date was updated to (b)(6) 2020, route of administration was updated from subcutaneous to intra-articular.Relevant lab data was added.Medical history of thyroid disorder added.Concurrent condition oof hypertension added.Corrective treatments were added.Clinical course was updated and text was amended.Based on the previously received information, in mir form, section 5: general comments, section 4.3.3 c-enter the number of similar incidents and devices on the market for the indicated time periods, in euca form- investigation result field were updated to reflect the updated aosi data received from cmde.
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