| Lot Number 7RSL021 |
| Device Problems
Nonstandard Device (1420); Microbial Contamination of Device (2303); Contamination of Device Ingredient or Reagent (2901); Device Contamination With Biological Material (2908)
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| Patient Problems
Arthritis (1723); Erythema (1840); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); Ambulation Difficulties (2544); Fluid Discharge (2686); No Code Available (3191)
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| Event Date 11/22/2017 |
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Event Type
Injury
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Event Description
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Based on additional information received on 06-dec- 2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 06-dec-2017 from a non-healthcare professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion, difficulty bearing weight, difficulty ambulating, stiffness, pain, swelling and bilateral drainage performed.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020).On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating.The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee.It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees.Action taken: unknown corrective treatment: 70cc drained from left knee and 50cc from right knee for bilateral drainage performed and swelling; not reported for rest of the events.Outcome: unknown for all the events a pharmaceutical technical complaint (ptc) was initiated with ptc number: 50914 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: device malfunction as important medical event.Additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of (b)(6) 2017).This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).The global ptc number with ptc result was added.Clinical course updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 6-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experience joint range of mition decreased, weight bearing difficulty and difficulty walking.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Based on additional information received on 05-feb- 2018, this case became medically confirmed (from health care professional).Based on additional information received on 06-dec- 2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 06-dec-2017 from a non-healthcare professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion, difficulty bearing weight, difficulty ambulating, stiffness, pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion.Also device malfunction was identified for the reported lot number.Concomitant medications include olmesartan medoxomil (benicar), fish oil and ergocalciferol (vitamin d).Patient had bilateral knee osteoarthritis, cancer, stroke, hypertension, degenerative disc disease lumbar.Patient had drug allergy- progesterone and sulfonamide on (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis/bilateral knee osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020).On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating.The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee.It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees.Corrective treatment: 70cc drained from left knee and 50cc from right knee for bilateral drainage performed/knee effusion and swelling/swollen; not reported for rest of the events.Outcome: recovered for pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion; unknown for rest events.Reporter causality description: yes for swollen and painful knee after synvisc one.A pharmaceutical technical complaint (ptc) was initiated with ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: device malfunction as important medical event.Additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of 06-dec-2017).This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).The global ptc number with ptc result was added.Clinical course updated.Text amended accordingly.Additional information was received on 05-feb-2018 from health care professional.This case became medically confirmed.Verbatim was updated for the event of bilateral drainage performed too bilateral drainage performed/knee effusion; pain to pain/increased pain/painful knee; swelling to swelling/swollen.Outcome was updated for the events of pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion from unknown to recovered.Clinical course updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 05 - feb - 18.The follow received does not change the previous assessment of the case.This case concerns a patient who has received synvisc one injection from the recalled lot and later experiencejoint range of mition decreased, weight bearing difficulty and difficulty walking.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction] ; decreased range of motion/couldn't move/i sat down and i couldn't get up [joint range of motion decreased]; difficulty ambulating/not walking right [difficulty in walking]; pain/increased pain/painful knee [knee pain]; swelling/swollen (recurrent) [swelling of knees]; legs hugely swelled up [swelling of legs]; bilateral drainage performed/knee effusion/took out as much gel and fluid as he could [knee effusion]; difficulty bearing weight [weight bearing difficulty]; my knees were still painful and not functioning [unspecified disorder of knee joint] bright red [erythema]; stiffness [joint stiffness]; noticed heat a swell [joint warmth].Case narrative: based on additional information received on 05-feb-2018, this case became medically confirmed (from health care professional).Based on additional information received on 06-dec-2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 06-dec-2017 from a non-healthcare professional.This case concerns a 70 year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty bearing weight, difficulty ambulating, stiffness, pain/increased pain/painful knee, swelling/swollen (recurrent) and bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, my knees were still painful and not functioning (latency: unknown) and legs hugely swelled up (latency: unknown), leg became red and was heating up (latency: same day).Also device malfunction was identified for the reported lot number.Concomitant medications include olmesartan medoxomil (benicar), fish oil and ergocalciferol (vitamin d).Patient had bilateral knee osteoarthritis, cancer, stroke, hypertension, degenerative disc disease lumbar.Patient had drug allergy- progesterone and sulfonamide.Patient has a family history of arthritis.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis/bilateral knee osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020).It was reported that patient she had a reaction as she was leaving the office after getting the shot.On the same day patient as leg became red and warm.On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating.The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee.It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees.It was reported that after patient got shot, patient ran a couple errands and went home and rested.Patient sat down and couldn't get up.On unknown date, after unknown latency, patient's legs hugely swelled up, it didn't hurt.Patient didn't even notice that they were swelling.Patient couldn't move.As patient's husband was out of town and patient was alone, it took 35 min to get to my phone which was only 10 feet away.Patient stated that it was horrible.Patient called a friend who came and stayed with her.Patient went to the doctor the next day and doctor took out as much gel and fluid as he could.Patient can't have lidocaine, so it was a very painful procedure.Patient had a walker.It was reported that on (b)(6) 2018 patient was supposed to go somewhere and had to cancel it.Patient wasn't able to get to the airport until (b)(6) 2018 and used a wheelchair to get onto and off of the flight.Around christmas, patient's knees were still painful and not functioning.Patient was not walking right and didn't have a walker.Patient was not able to do what i normally do until early (b)(6) and then knees were back to where they were before getting the shots.Patient still have a tiny bit of swelling but it doesn't hurt.These shots caused all sorts of problems; not just with her knees.Patient had flair and arthritis in hands because she had to use her hands to climb stairs.Patient's doctor used a cooling agent before putting in the synvisc-one.It was reported that patient had no allergies to eggs or feathers and was otherwise healthy.Patient have shrunk a little and weigh 61.23 kg.Patient's doctor told her to rest, ice.Elevate and take tylenol when her knees hurt.Patient was told to keep her legs above my heart.Again, very embarrassing and eventually painful.Patient continued to use ice and kept feet up as much as possible.As of (b)(6), patients hands had been doing my walking for about 6 weeks and they were hurting and weak.Her knees had improved, so that she could handle some things, but not steps or ramps.Patient saw the hand specialist in fl, who told her that she had overstressed her hands and the bones in the palm had fused and the bones of the fingers were so weak that patient had to give them immediate rest.The doctor sent prescribed splints for the hands and sent patient to a hand clinic for measurements and instruction.He encouraged patient to get a hot wax machine for home and follow up with doctors in md.Because the physician's diagnosis was so bleak.Patient recognize that arthritis was in her family.However, no one in patient's family has ever been unable to use their hands for everyday tasks unless they are 85 or older.And even then they just drop things, they aren't bad enough to change their dishes.Corrective treatment: 70cc drained from left knee and 50cc from right knee,walker,used a wheelchair swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; walker, used a wheelchair for legs hugely swelled up; not reported for rest of the events.Outcome: recovered for pain/increased pain/painful knee, my knees were still painful and not functioning; recovering for swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; unknown for rest events reporter causality description: yes for swollen and painful knee after synvisc one and not reported for the rest a product technical complaint was initiated on 29-dec-2017 for synvisc one, batch number: 7rsl021, global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction, decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty ambulating/not walking right, pain/increased pain/painful knee, swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of (b)(6) 2017).This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).The global ptc number with ptc result was added.Clinical course updated.Text amended accordingly.Additional information was received on 05-feb-2018 from health care professional.This case became medically confirmed.Verbatim was updated for the event of bilateral drainage performed too bilateral drainage performed/knee effusion; pain to pain/increased pain/painful knee; swelling to swelling/swollen.Outcome was updated for the events of pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion from unknown to recovered.Clinical course updated.Text amended accordingly.Follow up information was received on 26-feb-2018.No new information was received.Additional information was received on 12-mar-2018 from health care professional.Additional events of my knees were still painful and not functioning and legs hugely swelled up were added with details.Verbatim of swelling/swollen was updated to swelling/swollen (recurrent); bilateral drainage performed/knee effusion was updated to bilateral drainage performed/knee effusion/took out as much gel and fluid as he could; decreased range of motion was updated to decreased range of motion/couldn't move/i sat down and i couldn't get up.Outcome and corrective of pain/increased pain/painful knee, swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could and decreased range of motion/couldn't move/i sat down and i couldn't get up was updated.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.Follow up information was received on 14-mar-2018.No new information was received.Follow up information was received on 14-mar-2018.No new information was received.Additional information was received on 31-may-2018 from health care professional.New events of joint warmth and erythema were added.Clinical course was updated.Text was amended accordingly.
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Event Description
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Based on additional information received on 05-feb- 2018, this case became medically confirmed (from health care professional) based on additional information received on 06-dec- 2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).This case is cross referenced with case: (b)(4).This unsolicited case from united states was received on (b)(6) 2017 from a non-healthcare professional.This case concerns a 70 year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty bearing weight, difficulty ambulating, stiffness, pain/increased pain/painful knee, swelling/ swollen (recurrent) and bilateral drainage performed/ knee effusion/took out as much gel and fluid as he could, my knees were still painful and not functioning (latency: unknown) and legs hugely swelled up (latency: unknown).Also device malfunction was identified for the reported lot number.Concomitant medications include olmesartan medoxomil (benicar), fish oil and ergocalciferol (vitamin d).Patient had bilateral knee osteoarthritis, cancer, stroke, hypertension, degenerative disc disease lumbar.Patient had drug allergy- progesterone and sulfonamide on (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis/bilateral knee osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020).It was reported that patient she had a reaction as she was leaving the office after getting the shot.On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating.The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee.It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees.It was reported that after patient got shot, patient ran a couple errands and went home and rested.Patient sat down and couldn't get up.On unknown date, after unknown latency, patient's legs hugely swelled up, it didn't hurt.Patient didn't even notice that they were swelling.Patient couldn't move.As patient's husband was out of town and patient was alone, it took 35 min to get to my phone which was only 10 feet away.Patient stated that it was horrible.Patient called a friend who came and stayed with her.Patient went to the doctor the next day and doctor took out as much gel and fluid as he could.Patient can't have lidocaine, so it was a very painful procedure.Patient had a walker.It was reported that on (b)(6) 2018 patient was supposed to go somewhere and had to cancel it.Patient wasn't able to get to the airport until (b)(6) 2018 and used a wheelchair to get onto and off of the flight.Around christmas, patient's knees were still painful and not functioning.Patient was not walking right and didn't have a walker.Patient was not able to do what i normally do until early february and then knees were back to where they were before getting the shots.Patient still have a tiny bit of swelling but it doesn't hurt.These shots caused all sorts of problems; not just with her knees.Patient had flair and arthritis in hands because she had to use her hands to climb stairs.Patient's doctor used a cooling agent before putting in the synvisc-one.It was reported that patient had no allergies to eggs or feathers and was otherwise healthy.Patient have shrunk a little and weigh 61.23 kg.Patient's doctor told her to rest, ice.Elevate and take tylenol when her knees hurt.Patient was told to keep her legs above my heart.Corrective treatment: 70cc drained from left knee and 50cc from right knee,walker,used a wheelchair swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; walker, used a wheelchair for legs hugely swelled up; not reported for rest of the events.Outcome: recovered for pain/increased pain/painful knee, my knees were still painful and not functioning; recovering for swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; unknown for rest events reporter causality description: yes for swollen and painful knee after synvisc one a pharmaceutical technical complaint (ptc) was initiated with ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction, decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty ambulating/not walking right, pain/increased pain/painful knee, swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of 06-dec-2017).This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).The global ptc number with ptc result was added.Clinical course updated.Text amended accordingly.Additional information was received on 05-feb-2018 from health care professional.This case became medically confirmed.Verbatim was updated for the event of bilateral drainage performed too bilateral drainage performed/knee effusion; pain to pain/increased pain/painful knee; swelling to swelling/swollen.Outcome was updated for the events of pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion from unknown to recovered.Clinical course updated.Text amended accordingly.Follow up information was received on 26-feb-2018.No new information was received.Additional information was received on 12-mar-2018 from health care professional.Additional events of my knees were still painful and not functioning and legs hugely swelled up were added with details.Verbatim of swelling/swollen was updated to swelling/swollen (recurrent); bilateral drainage performed/knee effusion was updated to bilateral drainage performed/knee effusion/took out as much gel and fluid as he could; decreased range of motion was updated to decreased range of motion/couldn't move/i sat down and i couldn't get up.Outcome and corrective of pain/increased pain/painful knee, swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could and decreased range of motion/couldn't move/i sat down and i couldn't get up was updated.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 12-mar - 18.The follow received does not change the previous assessment of the case.This case concerns a patient who has received synvisc one injection from the recalled lot and later experience joint range of motion decreased, weight bearing difficulty and difficulty walking.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction] decreased range of motion/couldn't move/i sat down and i couldn't get up [joint range of motion decreased] difficulty ambulating/not walking right [difficulty in walking] pain/increased pain/painful knee [knee pain] swelling/swollen (recurrent) [swelling of knees] legs hugely swelled up [swelling of legs] bilateral drainage performed/knee effusion/took out as much gel and fluid as he could [knee effusion] difficulty bearing weight [weight bearing difficulty] my knees were still painful and not functioning [unspecified disorder of knee joint] bright red [erythema] stiffness [joint stiffness] noticed heat aswell [joint warmth].Case narrative: based on additional information received on 05-feb-2018, this case became medically confirmed (from health care professional).Based on additional information received on 06-dec-2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).This case is cross referenced with case: (b)(4).This unsolicited legal case from united states was received on 06-dec-2017 from a non-healthcare professional.This case concerns a 70 year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty bearing weight, difficulty ambulating, stiffness, pain/increased pain/painful knee, swelling/swollen (recurrent) and bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, my knees were still painful and not functioning (latency: unknown) and legs hugely swelled up (latency: unknown), leg became red and was heating up (latency: same day).Also device malfunction was identified for the reported lot number.Concomitant medications include olmesartan medoxomil (benicar), fish oil and ergocalciferol (vitamin d).Patient had bilateral knee osteoarthritis, cancer, stroke, hypertension, degenerative disc disease lumbar.Patient had drug allergy- progesterone and sulfonamide.Patient has a family history of arthrirtis.On (b)(6)2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis/bilateral knee osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020).It was reported that patient she had a reaction as she was leaving the office after getting the shot.On the same day patientâs leg became red and warm.On (b)(6)2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating.The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee.It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees.It was reported that after patient got shot, patient ran a couple errands and went home and rested.Patient sat down and couldn't get up.On unknown date, after unknown latency, patient's legs hugely swelled up, it didn't hurt.Patient didn't even notice that they were swelling.Patient couldn't move.As patient's husband was out of town and patient was alone, it took 35 min to get to my phone which was only 10 feet away.Patient stated that it was horrible.Patient called a friend who came and stayed with her.Patient went to the doctor the next day and doctor took out as much gel and fluid as he could.Patient can't have lidocaine, so it was a very painful procedure.Patient had a walker.It was reported that on (b)(6)2018 patient was supposed to go somewhere and had to cancel it.Patient wasn't able to get to the airport until(b)(6)2018 and used a wheelchair to get onto and off of the flight.Around christmas, patient's knees were still painful and not functioning.Patient was not walking right and didn't have a walker.Patient was not able to do what i normally do until early february and then knees were back to where they were before getting the shots.Patient still have a tiny bit of swelling but it doesn't hurt.These shots caused all sorts of problems; not just with her knees.Patient had flair and arthritis in hands because she had to use her hands to climb stairs.Patient's doctor used a cooling agent before putting in the synvisc-one.It was reported that patient had no allergies to eggs or feathers and was otherwise healthy.Patient have shrunk a little and weigh 61.23 kg.Patient's doctor told her to rest, ice.Elevate and take tylenol when her knees hurt.Patient was told to keep her legs above my heart.Again, very embarrassing and eventually painful.Patient continued to use ice and kept feet up as much as possible.As of january 19, patients hands had been doing my walking for about 6 weeks and they were hurting and weak.Her knees had improved, so that she could handle some things, but not steps or ramps.Patient saw the hand specialist in fl, who told her that she had overstressed her hands and the bones in the palm had fused and the bones of the fingers were so weak that patient had to give them immediate rest.The doctor sent prescribed splints for the hands and sent patient to a hand clinic for measurements and instruction.He encouraged patient to get a hot wax machine for home and follow up with doctors in md.Because the physician's diagnosis was so bleak.Patient recognize that arthritis was in her family.However, no one in patient's family has ever been unable to use their hands for everyday tasks unless they are 85 or older.And even then they just drop things, they aren't bad enough to change their dishes.Corrective treatment: 70cc drained from left knee and 50cc from right knee,walker,used a wheelchair swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; walker, used a wheelchair for legs hugely swelled up; not reported for rest of the events.Outcome: recovered for pain/increased pain/painful knee, my knees were still painful and not functioning; recovering for swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; unknown for rest events.Reporter causality description: yes for swollen and painful knee after synvisc one and not reported for the rest a product technical complaint was initiated on (b)(6)2017 for synvisc one, batch number: 7rsl021, global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction, decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty ambulating/not walking right, pain/increased pain/painful knee, swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could.Additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of (b)(6)2017).This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).The global ptc number with ptc result was added.Clinical course updated.Text amended accordingly.Additional information was received on 05-feb-2018 from health care professional.This case became medically confirmed.Verbatim was updated for the event of bilateral drainage performed too bilateral drainage performed/knee effusion; pain to pain/increased pain/painful knee; swelling to swelling/swollen.Outcome was updated for the events of pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion from unknown to recovered.Clinical course updated.Text amended accordingly.Follow up information was received on 26-feb-2018.No new information was received.Additional information was received on 12-mar-2018 from health care professional.Additional events of my knees were still painful and not functioning and legs hugely swelled up were added with details.Verbatim of swelling/swollen was updated to swelling/swollen (recurrent); bilateral drainage performed/knee effusion was updated to bilateral drainage performed/knee effusion/took out as much gel and fluid as he could; decreased range of motion was updated to decreased range of motion/couldn't move/i sat down and i couldn't get up.Outcome and corrective of pain/increased pain/painful knee, swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could and decreased range of motion/couldn't move/i sat down and i couldn't get up was updated.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.Follow up information was received on 14-mar-2018.No new information was received.Follow up information was received on 14-mar-2018.No new information was received.Additional information was received on 31-may-2018 from health care professional.New events of joint warmth and erythema were added.Clinical course was updated.Text was amended accordingly.Additional information received on 29-nov-2018 from lawyer.Case classification of legal added.Clinical course updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction].Decreased range of motion/couldn't move/i sat down and i couldn't get up/ b knees lacking full flexion due to 2017 injection [joint range of motion decreased].Difficulty ambulating/not walking right [difficulty in walking].Legs hugely swelled up [swelling of legs].Swelling/swollen (recurrent) [swelling of knees].Pain/increased pain/painful knee [knee pain].Bilateral drainage performed/knee effusion/took out as much gel and fluid as he could [knee effusion].Difficulty bearing weight [weight bearing difficulty].Bright red [erythema].Bakers cyst [baker's cyst].Bilateral hand pain [hand pain].Knees became injured post injection [knee injury].More crepitus on left knee [joint crepitation].Stiffness in hands [stiffness].Swelling in hands [swelling of hands].My knees were still painful and not functioning [unspecified disorder of knee joint].Stiffness [joint stiffness].Noticed heat aswell [joint warmth].Case narrative: based on additional information received on 05-feb-2018, this case became medically confirmed (from health care professional).Based on additional information received on 06-dec-2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).This case is cross referenced with case: (b)(4) (same patient for 2019 injection; left knee) and (b)(4) (same patient for 2019 injection; right knee).This unsolicited legal case from united states was received on 06-dec-2017 from a non-healthcare professional.This case concerns a 70 year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion/couldn't move/i sat down and i couldn't get up/ b knees lacking full flexion due to 2017 injection, difficulty bearing weight, difficulty ambulating, stiffness, pain/increased pain/painful knee, swelling/swollen (recurrent) and bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, my knees were still painful and not functioning (latency: unknown) legs hugely swelled up, baker's cyst, bilateral hand pain, stiffness in hands, swelling in hands, knees became injured post injection, more crepitus on left knee (latency: unknown), leg became red and was heating up (latency: same day).Also device malfunction was identified for the reported lot number.Patient had a history of bilateral knee osteoarthritis, cancer, stroke, hypertension, degenerative disc disease lumbar.Patient had drug allergy- progesterone and sulfonamide.Patient has a family history of arthritis.Concomitant medications include olmesartan medoxomil (benicar), fish oil and ergocalciferol (vitamin d).On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis/bilateral knee osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020).It was reported that patient she had a reaction as she was leaving the office after getting the shot.On the same day patients leg became red and warm.On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating.The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee.On an unknown date, after unknown latency, patient developed baker's cyst, stiffness with crepitus with more crepitus on left knee.It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees.It was reported that after patient got shot, patient ran a couple errands and went home and rested.Patient sat down and couldn't get up.On unknown date, after unknown latency, patient's legs hugely swelled up, it didn't hurt.Patient didn't even notice that they were swelling.Patient couldn't move.As patient's husband was out of town and patient was alone, it took 35 min to get to my phone which was only 10 feet away.Patient stated that it was horrible.Patient called a friend who came and stayed with her.Patient went to the doctor the next day and doctor took out as much gel and fluid as he could.Patient can't have lidocaine, so it was a very painful procedure.Patient had a walker.It was reported that on (b)(6) 2018 patient was supposed to go somewhere and had to cancel it.Patient wasn't able to get to the airport until on (b)(6) 2018 and used a wheelchair to get onto and off of the flight.Around christmas, patient's knees were still painful and not functioning.Patient was not walking right and didn't have a walker.Patient was not able to do what i normally do until early february and then knees were back to where they were before getting the shots.Patient still have a tiny bit of swelling but it doesn't hurt.These shots caused all sorts of problems; not just with her knees.Patient had flair and arthritis in hands because she had to use her hands to climb stairs.Patient's doctor used a cooling agent before putting in the synvisc-one.It was reported that patient had no allergies to eggs or feathers and was otherwise healthy.Patient have shrunk a little and weigh 61.23 kg.Patient's doctor told her to rest, ice.Elevate and take tylenol when her knees hurt.Patient was told to keep her legs above my heart.Again, very embarrassing and eventually painful.Patient continued to use ice and kept feet up as much as possible.As of on (b)(6), patient hands had been doing my walking for about 6 weeks and they were hurting and weak.Her knees had improved, so that she could handle some things, but not steps or ramps.Patient saw the hand specialist in fl, who told her that she had overstressed her hands and the bones in the palm had fused and the bones of the fingers were so weak that patient had to give them immediate rest.The doctor sent prescribed splints for the hands and sent patient to a hand clinic for measurements and instruction.He encouraged patient to get a hot wax machine for home and follow up with doctors in md.Because the physician's diagnosis was so bleak.Patient recognize that arthritis was in her family.However, no one in patient's family has ever been unable to use their hands for everyday tasks unless they are 85 or older.And even then they just drop things, they aren't bad enough to change their dishes.On an unknown date, after unknown latency, patient had bilateral hand pain, stiffness and swelling with left hand worse than right hand.Patient attributed bilateral hand pain developed when patient had to climb on her hands once as her knees were injured post injection.Action taken: not applicable for all events.Corrective treatment: 70cc drained from left knee and 50cc from right knee, walker, used a wheelchair swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; walker, used a wheelchair for legs hugely swelled up; not reported for rest of the events.Outcome: recovered for pain/increased pain/painful knee, my knees were still painful and not functioning; recovering for swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could, decreased range of motion/couldn't move/i sat down and i couldn't get up; unknown for rest events.A product technical complaint was initiated on 29-dec-2017 for synvisc one, batch number: 7rsl021, global ptc: number 50914.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot: 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction, decreased range of motion/couldn't move/i sat down and i couldn't get up, difficulty ambulating/not walking right, pain/increased pain/painful knee, swelling/swollen (recurrent), legs hugely swelled up, bilateral drainage performed/knee effusion/took out as much gel and fluid as he could.Additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of 06-dec-2017).This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime).The global ptc number with ptc result was added.Clinical course updated.Text amended accordingly.Additional information was received on 05-feb-2018 from health care professional.This case became medically confirmed.Verbatim was updated for the event of bilateral drainage performed too bilateral drainage performed/knee effusion; pain to pain/increased pain/painful knee; swelling to swelling/swollen.Outcome was updated for the events of pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion from unknown to recovered.Clinical course updated.Text amended accordingly.Follow up information was received on 26-feb-2018.No new information was received.Additional information was received on 12-mar-2018 from health care professional.Additional events of my knees were still painful and not functioning and legs hugely swelled up were added with details.Verbatim of swelling/swollen was updated to swelling/swollen (recurrent); bilateral drainage performed/knee effusion was updated to bilateral drainage performed/knee effusion/took out as much gel and fluid as he could; decreased range of motion was updated to decreased range of motion/couldn't move/i sat down and i couldn't get up.Outcome and corrective of pain/increased pain/painful knee, swelling/swollen (recurrent), bilateral drainage performed/knee effusion/took out as much gel and fluid as he could and decreased range of motion/couldn't move/i sat down and i couldn't get up was updated.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.Follow up information was received on 14-mar-2018.No new information was received.Follow up information was received on 14-mar-2018.No new information was received.Additional information was received on 31-may-2018 from health care professional.New events of joint warmth and erythema were added.Clinical course was updated.Text was amended accordingly.Additional information received on 29-nov-2018 from lawyer.Case classification of legal added.Clinical course updated.Text amended accordingly.Follow up information received on 31-jul-2019 from lawyer.No new information.Additional information received on 02-jan-2020 from lawyer.Events of baker's cyst, bilateral hand pain, stiffness in hands, swelling in hands, knees became injured post injection, more crepitus on left knee added.Related case ids (for synvisc injection in 2019) added.Clinical course updated and text amended accordingly.
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