| Lot Number 7RSL021 |
| Device Problems
Contamination (1120); Device Contamination With Biological Material (2908)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Arthralgia (2355); Joint Swelling (2356)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on 26-dec-2017 from patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee in (b)(6) 2016.On (b)(6) 2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On (b)(6) 2017, patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On (b)(6) 2017, patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on (b)(6) 2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events 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 (b)(6) 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti pharmacovigilance comment: sanofi company comment dated 30-12-2017: this case concerns a (b)(6) female patient who developed walking difficulty, limbs stiffness, mobility decreased, weight bearing difficulty and joint range of motion decreased; following device malfunction; after receiving injection of synvisc-one.Although the role of drug cannot be denied for the events; however, patient's advancing age and underlying condition of pain in knees are confounding factors for the same.Moreover, information regarding lifestyle history, family history, concurrent conditions, relevant medical history and concomitant medications will aid in comprehensive assessment of this case.
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Event Description
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Device malfunction [device malfunction].Could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking [walking difficulty].My legs felt like cinder blocks from the knees down [limbs stiffness].Couldn't bend my knees/no range of motion in my knees [joint range of motion decreased].No range of motion [mobility decreased].Couldn't bear weight [weight bearing difficulty].An allergic reaction to the synvisc-one [allergic reaction].Reaction to the shot/knees were very painful [knee pain].Lot of stiffness/knees were tight [stiff knees.] knees were swollen [swelling of knees].Uti [uti] ([fever]).Case narrative: this unsolicited case from united states was received on 26-dec-2017 from patient.This case concerns a 62 years old female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee on (b)(6) 2016.On (b)(6) 2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On (b)(6) 2017, patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On (b)(6) 2017, patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on (b)(6) 2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events.A global pharmaceutical technical complaint 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti.Additional information was received on 29-dec-2017.The gptc number was added.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction].Could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking [walking difficulty].My legs felt like cinder blocks from the knees down [limbs stiffness].Couldn't bend my knees/no range of motion in my knees [joint range of motion decreased].No range of motion [mobility decreased].Couldn't bear weight [weight bearing difficulty].An allergic reaction to the synvisc-one [allergic reaction].Reaction to the shot/knees were very painful [knee pain].Lot of stiffness/knees were tight [stiff knees].Knees were swollen [swelling of knees].Uti [uti] ([fever]).Case narrative: this unsolicited case from united states was received on 26-dec-2017 from patient.This case concerns a 62 years old female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee in mar-2016 and nov-2016.On 21-nov-2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On 22-nov-2017, patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On 14-dec-2017, patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on 27-dec-2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events.A global pharmaceutical technical complaint was initiated with ptc number: 51601 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti.Additional information was received on 29-dec-2017.The gptc number was added.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction] could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking [walking difficulty] my legs felt like cinder blocks from the knees down [limbs stiffness] couldn't bend my knees/no range of motion in my knees [joint range of motion decreased] no range of motion [mobility decreased] couldn't bear weight [weight bearing difficulty] an allergic reaction to the synvisc-one [allergic reaction] reaction to the shot/knees were very painful [knee pain] lot of stiffness/knees were tight [stiff knees] knees were swollen [swelling of knees] uti [uti] ([fever]) case narrative: this unsolicited case from united states was received on 26-dec-2017 from patient.This case concerns a 62 years old female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee in (b)(6) 2016.On (b)(6) 2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On (b)(6) 2017, patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On (b)(6) 2017, patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on (b)(6) 2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events a global pharmaceutical technical complaint 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti additional information was received on 29-dec-2017.The gptc number was added.Text amended accordingly.Upon internal review on 11sep2023 it was identified that a ha reference id associated with the case (b)(4) was erroneously entered into case (b)(4).Following ha guidance received on 27sep2023, additional submissions with the correct case data was performed in order to nullify the previously submitted incorrect case data.
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Event Description
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Device malfunction [device malfunction] could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking [walking difficulty] my legs felt like cinder blocks from the knees down [limbs stiffness] couldn't bend my knees/no range of motion in my knees [joint range of motion decreased] no range of motion [mobility decreased] couldn't bear weight [weight bearing difficulty] an allergic reaction to the synvisc-one [allergic reaction] reaction to the shot/knees were very painful [knee pain] lot of stiffness/knees were tight [stiff knees] knees were swollen [swelling of knees] uti [uti] ([fever]) case narrative: this unsolicited case from united states was received on 26-dec-2017 from patient.This case concerns a 62 years old female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee in mar-2016 and nov-2016.On (b)(6) 2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On (b)(6) 2017, patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On (b)(6) 2017, patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on (b)(6) 2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events a global pharmaceutical technical complaint 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti additional information was received on 29-dec-2017.The gptc number was added.Text amended accordingly.Upon internal review on 11sep2023 it was identified that a ha reference id associated with the case (b)(4) was erroneously entered into case (b)(6).Following ha guidance received on 27sep2023, additional submissions with the correct case data was performed in order to nullify the previously submitted incorrect case data.
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Event Description
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Device malfunction [device malfunction].Could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking [walking difficulty].My legs felt like cinder blocks from the knees down [limbs stiffness].Couldn't bend my knees/no range of motion in my knees [joint range of motion decreased].No range of motion [mobility decreased].Couldn't bear weight [weight bearing difficulty].An allergic reaction to the synvisc-one [allergic reaction].Reaction to the shot/knees were very painful [knee pain].Lot of stiffness/knees were tight [stiff knees].Knees were swollen [swelling of knees].Uti [uti] ([fever]).Case narrative: this unsolicited case from united states was received on (b)(6) 2017
from patient.This case concerns a 62 years old female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee in (b)(6) 2016.On (b)(6) 2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On (b)(6) 2017 patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On (b)(6) 2017 , patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on (b)(6) 2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events.A global pharmaceutical technical complaint 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti.Additional information was received on 29-dec-2017.The gptc number was added.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction].Could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking [walking difficulty].My legs felt like cinder blocks from the knees down [limbs stiffness].Couldn't bend my knees/no range of motion in my knees [joint range of motion decreased].No range of motion [mobility decreased].Couldn't bear weight [weight bearing difficulty].An allergic reaction to the synvisc-one [allergic reaction].Reaction to the shot/knees were very painful [knee pain].Lot of stiffness/knees were tight [stiff knees].Knees were swollen [swelling of knees].Uti [uti] ([fever]).Case narrative: this unsolicited case from united states was received on 26-dec-2017 from patient.This case concerns a 62 years old female patient who received treatment with synvisc one injection and after few hours had reaction to the shot/knees were very painful, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down on the same day and no range of motion, after 1 day couldn't bend my knees/no range of motion in my knees and lot of stiffness/knees were tight, after unknown latency couldn't bear weight, had an allergic reaction to the synvisc-one, knees were swollen and had urinary tract infection after 23 days.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in right knee on (b)(6) 2016.On (b)(6) 2017, at 09:30-10:00 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided).On the same day, few hours after the injection, patient had reaction to the shot and within 3 hrs her knees were very painful.Patient called the doctor and was told that she had a reaction.It was reported that the patient's knees just don't feel the same, doctor told her to take 3 advil per day for pain.On the same day, within two hours or so after getting the injection, patient could hardly walk.At 01:00 pm in afternoon patient was having trouble walking.Patient was not told that she had to restrict motion, so she went walking around like usually.Patient couldn't get home fast enough and had no range of motion and her legs felt like cinder blocks from the knees down.Patient took advil as recommended by doctor.On (b)(6) 2017, patient could hardly walk and had a lot of stiffness.Patient could not bend knees and could not walk.Patient called doctor who told patient that it sounded like patient was having an allergic reaction to the synvisc-one.Patient was recommended to take 3 advil and 2 benadryl every 8 hours for 3 days and the doctor called in medrol pack on saturday after the shot.Patient's knees had not felt right since.On (b)(6) 2017, patient had a uti.Patient was not sure if this was caused by the synvisc-one or not.Patient had no range of motion in knees and couldn't bend them.This made it difficult to go to the bathroom.Patient was also walking funny on knees and that had caused her right ankle to start bothering.Patient would have a magnetic resonance imaging on (b)(6) 2017.Patient was still having a hard time walking and bending legs.Patient can bend knees some, but was shuffling along.Patient couldn't bend knees soon after the injection.Patient was able to bend them before getting the synvisc-one injections.The medrol pack helped, but patient was still not 100%.Patient's knees were swollen and tight, tight, tight.Patient could not bear weight or bend either of her knees.Patient did not think that she got any relief from the shot.Before getting the shot, my pain was a 5/10 and it was still at a 5/10.After the shot, it was not that the patient had so much pain in the knee, but instead patient just had a lot of swelling and no range of motion.Patient never had to have fluid drained from my knee.No cultures were taken.Patient was not put on antibiotics.Patient had a fever the day after getting the shots in both knees.Patient still did not knew if she had a possible allergic reaction to the synvisc-one and a reaction from the recall issue.Corrective treatment: methylprednisolone (medrol) for device malfunction, lot of stiffness/knees were tight, knees were swollen, could hardly walk/trouble walking/couldn't walk/walking funny on my knees/hard time walking, my legs felt like cinder blocks from the knees down, couldn't bend my knees/no range of motion in my knees, no range of motion, couldn't bear weight and ibuprofen (advil), diphenhydramine hydrochloride (benadryl), methylprednisolone pack for an allergic reaction to the synvisc-one, reaction to the shot/knees were very painful and antibiotics for uti.Outcome: not recovered for all events.A global pharmaceutical technical complaint 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all events except uti.Additional information was received on 29-dec-2017.The gptc number was added.Text amended accordingly.Upon internal review on 11sep2023, it was identified that a ha reference id associated with the case: (b)(4) was erroneously entered into case: (b)(4).Following ha guidance received on 27sep2023, additional submissions with the correct case data was performed in order to nullify the previously submitted incorrect case data.
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