| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Synovitis (2094); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 08/14/2023 |
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Event Type
Injury
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Event Description
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Meniscus tears [meniscus tear] ([pain localised]) unable to move as normal described as prior exercising 5-days a week to now being left to sit on the couch all day [mobility decreased] threw her other leg off/it was the way she was walking now to compensate for the knee/was dragging her leg and was having to use a walker/can¿t lean on knee at all, she limps, she waddles/has aggravated/cannot walk very far [gait disturbance] ([condition aggravated]) synovial lining inflammation [injection site synovitis] ([injection site joint effusion], [injection site joint pain], [injection site joint swelling], [stiff knees], [arthrocentesis], [white blood cell count increased], [synovial fluid analysis abnormal]) during the last injection of synvisc one she received that she felt extreme pressure under her kneecap, like her kneecap was rising which the patient believes had to do with the injection itself [injection site joint discomfort] caused tendonitis now in her right hip [tendonitis] baker cyst pain [baker's cyst] ([pain localised]) aggravated her shoulder problem [unspecified disorder of joint of shoulder region] ([condition aggravated]) low grade fever [low grade fever] used synvisc one for knee lubrication with no reported adverse event [product use in unapproved indication].Case narrative: initial information was received from united states on 28-dec-2023 regarding an unsolicited valid serious case from a patient.This case involves a 67 years old female patient who had meniscus tears, unable to move as normal described as prior exercising 5-days a week to now being left to sit on the couch all day, threw her other leg off/it was the way she was walking now to compensate for the knee/was dragging her leg and was having to use a walker/can't lean on knee at all, she limps, she waddles/has aggravated/cannot walk very far, synovial lining inflammation, caused tendonitis now in her right hip, baker cyst pain, aggravated her shoulder problem, during the last injection of synvisc one she received that she felt extreme pressure under her kneecap, like her kneecap was rising which the patient believes had to do with the injection itself, low grade fever while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].Also, patient and used synvisc one for knee lubrication with no adverse event reported directly linked to this product use in unapproved indication.The patient stated she had knee orthoscopic surgery starting in 1996 and again in the early 2000s, she had a baker cyst repair which was beautiful.She never had a problem with her baker cyst again.In 2021, she had back surgery.The patient stated she started taking synvisc one injections, because she was working out all the time and she had synvisc one injections two to three times without any problem prior to getting the last injection ((b)(6) 2023).She had got it again because she knew her knee and it felt like she needed the injection again to get her knee lubricated again, that it always had helped in the past and worked beautifully.The patient stated that prior to last injection she was working out 5 days a week.The patient stated she wasn't hurting before the injection.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2023, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, 48 mg/6ml) injection in left knee (with an unknown batch number, expiry date, dose, frequency, route) for knee lubrication (product use in unapproved indication, latency: same day).Information on batch number was requested.The patient did not receive injection for the first time.On (b)(6) 2023, on same day of receiving injection, during the last injection of synvisc one she received, she felt extreme pressure under her kneecap, like her kneecap was rising which the patient believes had to do with the injection itself (injection site joint discomfort).The patient asked how many days after the last injection could pass before any kind of problem could occur, her doctor said 1 to 2 days but that she did not begin having a problem until 4 days after the last injection.On (b)(6) 2023, the patient stated that 4 days after, she started hurting/bad left knee pain (injection site joint pain), swelling (injection site joint swelling) and then became stiffer and stiffer (joint stiffness) and her knee became bigger and bigger (injection site joint swelling) (all events required intervention).Her doctor said that any problems with the injection would have occurred within 1 to 2 days and that was why her doctor did not think the injection had anything to do with what she was experiencing.By the (b)(6) 2023, after latency of 9 days she was walking on a walker (gait disturbance, caused disability).On (b)(6) 2023, after latency of 12 days, the doctor at the emergency room drained the knee, the fluid was clear/not cloudy (aspiration joint, injection site joint effusion, required intervention), and gave her a cortisone injection.By friday ((b)(6) 2023), the knee filled up again (injection site joint effusion, required intervention).She saw the prescriber again on (b)(6) 2023 but he did not drain the left knee.By sunday ((b)(6) 2023), after latency of 17 days, she wound up in the emergency room and that doctor thought she had septic arthritis.Her left knee was drained using an ultrasound guided needle and the fluid in the knee was now cloudy (synovial fluid analysis abnormal) but the culture came back negative so they ruled out septic arthritis.They ordered meloxicam and mri (magnetic resonance imaging).Also, at the time of the emergency room, her white blood cell count had gone to 14560 (white blood cell count increased, onset date: (b)(6) 2023, latency: 17 days).On same day, she had a low-grade fever (pyrexia) and was placed on antibiotics.The patient stated that from what she looked up on pseudo sepsis, she had every single symptom except that her white blood count did go up to 14,560-something, but that she had every other symptom.On (b)(6) 2023, they gave her the results for the mri which showed synovial lining inflammation (injection site joint inflammation, onset date: aug or (b)(6) 2023, latency: few days).The patient was asked if she could get cleared for surgery the next morning (on (b)(6) 2023).The patient stated that something went wrong, and she had to go in for emergency surgery.The patient stated she didn't have time to think because she had been hurting for several weeks from (b)(6) until (b)(6) 2023 and her problems had been going on a month before that since she got the synvisc one injection.The patient stated the mri showed she did not have any tears but her doctor said when he went in there during surgery, the patient had tears (meniscus injury, onset date: (b)(6) 2023, latency: 27 days, required intervention) so the physician did a meniscectomy on both sides, on the latter side and the medial side.They had to go in and remove synovial inflamed lining in her knee.Since she had this surgery on (b)(6) 2023, she had meniscus pain (pain) and baker cyst pain (synovial cyst, pain) (onset date: (b)(6) 2023, latency: few days for both events), which she did not have prior.The patient stated that now she actually hurt, that now she threw her other leg off (gait disturbance, caused disability), that her doctor told her to go back to her back doctor to make sure nothing was going on with her back.The patient stated the doctor told her it was not her back, that it was the way she was walking now to compensate for the knee (gait disturbance, caused disability).The patient stated that she was unable to move as normal and instead of working out as prior exercising 5-days a week, she now had to spend most days sitting on the couch most of the time (mobility decreased, onset date: 2023, latency: few months, caused disability) now, she hurts behind her knee, the medial side (injection site joint pain, required intervention), her knee was swollen up (injection site joint swelling, required intervention), she could not lean on her knee at all, she limped, she waddled, so now this had aggravated (gait disturbance, condition aggravated, caused disability) and caused tendonitis now in her right hip (tendonitis, onset date: 2023, latency: few months).The patient thought her brain was protecting her left knee now.The patient stated she was supposed to be calling to see a knee surgeon.The patient stated she could not live this way, that she could not go anywhere though she did go get a vaccine for covid, and that she did go to her doctor for her physical appointment.The patient stated she could not walk very far, that she wore a brace right now (gait disturbance, caused disability).The patient stated she was dragging her leg and was having to use a walker (gait disturbance, caused disability).The patient stated she had other synvisc one injections that never bothered her but that this last one did.The patient stated she was 67 years old and that it really bothered her because before all this happened, she was more like a person in their 50s.The patient stated that now she did feel like she's 67.Now she was swollen, she hurts, which was still going on and that now her doctor wanted the patient to go see an orthopedic surgeon (knee doctor) about a left knee replacement.The patient was having to use her walker again and it has aggravated her shoulder problem (arthropathy, condition aggravated, onset date: 2023, latency: few months).The patient stated she felt like all that had happened to her was because her doctor waited too long and did not take her seriously.The patient stated that on (b)(6) 2024 it would be 5 months since the emergency surgery (on knee) and her doctor was now pawning her off to have a knee replacement.Relevant laboratory test results included: aspiration joint - on (b)(6) 2023: the fluid was clear; on (b)(6) 2023: fluid in the knee was now cloudy culture - on (b)(6) 2023: negative magnetic resonance imaging - in 2023: mri showed synovial lining inflammation (done in aug end or sep starting) white blood cell count - on (b)(6) 2023: had gone to 14560.Action taken: not applicable for all the events.Corrective treatment: meniscectomy on both sides, on the latter side and the medial side, knee drained twice, unspecified antibiotics, cortisone and meloxicam for synovial lining inflammation; unspecified antibiotics, and meloxicam for low grade fever; meniscectomy on both sides, on the latter side and the medial side for meniscus tears, walking on a walker and wore a brace for gait disturbance and mobility decreased, not reported for tendonitis, synovial cyst, arthropathy, and injection site joint discomfort.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 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.At time of reporting, the outcome was unknown for injection site joint discomfort, injection site joint inflammation and product use in unapproved indication and, not recovered for rest all the events.
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Manufacturer Narrative
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Sanofi company comment dated 04-jan-2024: this case involves a 67 years old female patient who had meniscus tears, unable to move as normal described as prior exercising 5-days a week to now being left to sit on the couch all day, threw her other leg off/it was the way she was walking now to compensate for the knee/was dragging her leg and was having to use a walker/can't lean on knee at all, she limps, she waddles/has aggravated/cannot walk very far, synovial lining inflammation, while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] for knee lubrication (product use in unapproved indication).Based on the available information, causal relationship between the events and suspect product could not be excluded.Patient¿s elderly age, history of knee orthoscopic surgery and baker cyst might also have played role in occurrence of reported events.However, further information regarding batch number, investigation results, injection technique, post injection routine, patient¿s past medications, concomitant medications, all underlying disease conditions (in left knee), and other risk factors would aid in better case assessment.
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Event Description
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Meniscus tears [meniscus tear] ([pain localised]).Unable to move as normal described as prior exercising 5-days a week to now being left to sit on the couch all day [mobility decreased].Threw her other leg off/it was the way she was walking now to compensate for the knee/was dragging her leg and was having to use a walker/can¿t lean on knee at all, she limps, she waddles/has aggravated/cannot walk very far [gait disturbance] ([condition aggravated]) synovial lining inflammation [injection site synovitis] ([injection site joint effusion], [injection site joint pain], [injection site joint swelling], [stiff knees], [arthrocentesis], [white blood cell count increased], [synovial fluid analysis abnormal]) during the last injection of synvisc one she received that she felt extreme pressure under her kneecap, like her kneecap was rising which the patient believes had to do with the injection itself [injection site joint discomfort] caused tendonitis now in her right hip [tendonitis] baker cyst pain [baker's cyst] ([pain localised]) aggravated her shoulder problem [unspecified disorder of joint of shoulder region] ([condition aggravated]) low grade fever [low grade fever] used synvisc one for knee lubrication with no reported adverse event [product use in unapproved indication] case narrative: initial information was received from united states on 28-dec-2023 regarding an unsolicited valid serious case from a patient.This case involves a 67 years old female patient who had meniscus tears, unable to move as normal described as prior exercising 5-days a week to now being left to sit on the couch all day, threw her other leg off/it was the way she was walking now to compensate for the knee/was dragging her leg and was having to use a walker/can't lean on knee at all, she limps, she waddles/has aggravated/cannot walk very far, synovial lining inflammation, caused tendonitis now in her right hip, baker cyst pain, aggravated her shoulder problem, during the last injection of synvisc one she received that she felt extreme pressure under her kneecap, like her kneecap was rising which the patient believes had to do with the injection itself, low grade fever while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].Also, patient and used synvisc one for knee lubrication with no adverse event reported directly linked to this product use in unapproved indication.The patient stated she had knee orthoscopic surgery starting in 1996 and again in the early 2000s, she had a baker cyst repair which was beautiful.She never had a problem with her baker cyst again.In 2021, she had back surgery.The patient stated she started taking synvisc one injections, because she was working out all the time and she had synvisc one injections two to three times without any problem prior to getting the last injection ((b)(6) 2023).She had got it again because she knew her knee and it felt like she needed the injection again to get her knee lubricated again, that it always had helped in the past and worked beautifully.The patient stated that prior to last injection she was working out 5 days a week.The patient stated she wasn't hurting before the injection.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6)2023, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, 48 mg/6ml) injection in left knee (with an unknown batch number, expiry date, dose, frequency, route) for knee lubrication (product use in unapproved indication, latency: same day).Information on batch number was requested.The patient did not receive injection for the first time.On (b)(6) 2023, on same day of receiving injection, during the last injection of synvisc one she received, she felt extreme pressure under her kneecap, like her kneecap was rising which the patient believes had to do with the injection itself (injection site joint discomfort).The patient asked how many days after the last injection could pass before any kind of problem could occur, her doctor said 1 to 2 days but that she did not begin having a problem until 4 days after the last injection.On (b)(6) 2023, the patient stated that 4 days after, she started hurting/bad left knee pain (injection site joint pain), swelling (injection site joint swelling) and then became stiffer and stiffer (joint stiffness) and her knee became bigger and bigger (injection site joint swelling) (all events required intervention).Her doctor said that any problems with the injection would have occurred within 1 to 2 days and that was why her doctor did not think the injection had anything to do with what she was experiencing.By the (b)(6) 2023, after latency of 9 days she was walking on a walker (gait disturbance, caused disability).On (b)(6) 2023, after latency of 12 days, the doctor at the emergency room drained the knee, the fluid was clear/not cloudy (aspiration joint, injection site joint effusion, required intervention), and gave her a cortisone injection.By friday ((b)(6) 2023), the knee filled up again (injection site joint effusion, required intervention).She saw the prescriber again on (b)(6) 2023 but he did not drain the left knee.By sunday ((b)(6) 2023), after latency of 17 days, she wound up in the emergency room and that doctor thought she had septic arthritis.Her left knee was drained using an ultrasound guided needle and the fluid in the knee was now cloudy (synovial fluid analysis abnormal) but the culture came back negative so they ruled out septic arthritis.They ordered meloxicam and mri (magnetic resonance imaging).Also, at the time of the emergency room, her white blood cell count had gone to 14560 (white blood cell count increased, onset date: (b)(6) 2023, latency: 17 days).On same day, she had a low-grade fever (pyrexia) and was placed on antibiotics.The patient stated that from what she looked up on pseudo sepsis, she had every single symptom except that her white blood count did go up to 14,560-something, but that she had every other symptom.On (b)(6) 2023, they gave her the results for the mri which showed synovial lining inflammation (injection site joint inflammation, onset date: (b)(6) 2023, latency: few days).The patient was asked if she could get cleared for surgery the next morning (on (b)(6)2023).The patient stated that something went wrong, and she had to go in for emergency surgery.The patient stated she didn't have time to think because she had been hurting for several weeks from (b)(6) 2023 and her problems had been going on a month before that since she got the synvisc one injection.The patient stated the mri showed she did not have any tears but her doctor said when he went in there during surgery, the patient had tears (meniscus injury, onset date: (b)(6)2023, latency: 27 days, required intervention) so the physician did a meniscectomy on both sides, on the latter side and the medial side.They had to go in and remove synovial inflamed lining in her knee.Since she had this surgery on (b)(6) 2023, she had meniscus pain (pain) and baker cyst pain (synovial cyst, pain) (onset date: (b)(6) 2023, latency: few days for both events), which she did not have prior.The patient stated that now she actually hurt, that now she threw her other leg off (gait disturbance, caused disability), that her doctor told her to go back to her back doctor to make sure nothing was going on with her back.The patient stated the doctor told her it was not her back, that it was the way she was walking now to compensate for the knee (gait disturbance, caused disability).The patient stated that she was unable to move as normal and instead of working out as prior exercising 5-days a week, she now had to spend most days sitting on the couch most of the time (mobility decreased, onset date: 2023, latency: few months, caused disability) now, she hurts behind her knee, the medial side (injection site joint pain, required intervention), her knee was swollen up (injection site joint swelling, required intervention), she could not lean on her knee at all, she limped, she waddled, so now this had aggravated (gait disturbance, condition aggravated, caused disability) and caused tendonitis now in her right hip (tendonitis, onset date: 2023, latency: few months).The patient thought her brain was protecting her left knee now.The patient stated she was supposed to be calling to see a knee surgeon.The patient stated she could not live this way, that she could not go anywhere though she did go get a vaccine for covid, and that she did go to her doctor for her physical appointment.The patient stated she could not walk very far, that she wore a brace right now (gait disturbance, caused disability).The patient stated she was dragging her leg and was having to use a walker (gait disturbance, caused disability).The patient stated she had other synvisc one injections that never bothered her but that this last one did.The patient stated she was 67 years old and that it really bothered her because before all this happened, she was more like a person in their 50s.The patient stated that now she did feel like she's 67.Now she was swollen, she hurts, which was still going on and that now her doctor wanted the patient to go see an orthopedic surgeon (knee doctor) about a left knee replacement.The patient was having to use her walker again and it has aggravated her shoulder problem (arthropathy, condition aggravated, onset date: 2023, latency: few months).The patient stated she felt like all that had happened to her was because her doctor waited too long and did not take her seriously.The patient stated that on (b)(6) 2024 it would be 5 months since the emergency surgery (on knee) and her doctor was now pawning her off to have a knee replacement.Relevant laboratory test results included: aspiration joint - on (b)(6) 2023: the fluid was clear; on (b)(6) 2023: fluid in the knee was now cloudy culture - on (b)(6) 2023: negative.Magnetic resonance imaging - in 2023: mri showed synovial lining inflammation (done in aug end or sep starting) white blood cell count - on (b)(6) 2023: had gone to 14560.Action taken: not applicable for all the events corrective treatment: meniscectomy on both sides, on the latter side and the medial side, knee drained twice, unspecified antibiotics, cortisone and meloxicam for synovial lining inflammation; unspecified antibiotics, and meloxicam for low grade fever; meniscectomy on both sides, on the latter side and the medial side for meniscus tears, walking on a walker and wore a brace for gait disturbance and mobility decreased, not reported for tendonitis, synovial cyst, arthropathy, and injection site joint discomfort.At time of reporting, the outcome was unknown for injection site joint discomfort, injection site joint inflammation and product use in unapproved indication and, not recovered for rest all the events a product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: preliminary assessment: 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.((b)(4)) investigation: ((b)(4)) 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 09-jan-2024 with summarized conclusion as no assessment possible.Additional information was received on 28-dec-2023 by quality department from other health care professional: ptc number added.Text amended accordingly.Additional information was received on 09-jan-2024 by quality department from other health care professional: ptc results were added.Text amended accordingly.
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