| Lot Number 7RSL021 |
| Device Problem
Device Contamination With Biological Material (2908)
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| Patient Problems
Fever (1858); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Ambulation Difficulties (2544); Alteration In Body Temperature (2682); Fluid Discharge (2686)
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| Event Date 01/01/2017 |
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Event Type
malfunction
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Event Description
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Based on the information received on 11-dec-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This unsolicited case from united states was received on 11-dec-2017 from patient.This case concerns a patient (demographics not provided) who received treatment with synvisc one injection and after a latency of 1 day had extreme swelling/ right knee was twice the size of the left knee, pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving, could not put weight on the knee, could not move the right knee, was warm to touch/ right knee felt warmer than other knee; after 4 days had ankle had swelling; after unknown latency had fever of 99.8 and knee drained, also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (dose, indication, batch/lot number and expiration date: not provided).On (b)(6) 2017, after a latency of 1 day, his right knee started swelling, was warm to the touch, could not move the right knee, it hurt, and could not put weight on the knee.He said he called his physician the first time the he experienced the swelling.He said he kept it elevated, iced and used ibuprofen 200 mg 2 tablets daily when needed.He said the swelling was not that back at first.He said he went back to work on (b)(6) 2017 and he had to stand on his feet for 12 hours doing his work.He said after 6:00 pm on the same day, his right knee and right ankle had swollen (onset: (b)(6) 2017; latency: 4 days) and was hurting to bare weight on it.He said, 10 minutes after 7:00 pm on the same day, he went to the emergency room about his knee and ankle symptoms.He said the people in the emergency room asked about his pain from a scale of 1 to 10 and 10 being the highest.He said his pain was between 7 and 8.He said that on (b)(6) 2017 morning, he called his orthopedic surgeon and he was going to schedule a mri because he had not received the synvisc-one recall notice.He said, on (b)(6) 2017, he was called back to the orthopedic surgeon and he drained 110 cc of fluid from his right knee.He said he did not have the mri.He said the orthopedic surgeon told him to ice, elevate, and take ibuprofen 200 mg 2 tablets as needed for the pain and inflammation.He said he had been doing this since and his orthopedic surgeon schedule another visit on (b)(6) 2018 to see if the knee had improved.He said he is recovering and if he is lying down on his couch, his knee does not experience any pain or inflammation but if he is in his car driving he said the right knee pain is like someone sticking him with an ice pick.He said if he stands too long like the 12 hours at work he would experience pain and swelling.He is still recovering from his symptoms.On an unknown date in 2017, after an unknown latency, patient's temperature was 99.8 and his right knee felt warmer than other knee.Corrective treatment: knee drained; ice; elevated ; ibuprofen for extreme swelling/ right knee was twice the size of the left knee; ice; elevated ; ibuprofen for pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving; 110 cc of fluid drained for knee drained; ice for warm to touch/ right knee felt warmer than other knee; not reported for rest outcome: recovering for all seriousness criteria: important medical event for device malfunction.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.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.Additional information was received on (b)(6) 2017 from the patient (both processed with the clock start date of (b)(6) 2017).Events of device malfunction, fever of 99.8, could not put weight on the knee, could not move the right knee, warm to touch/ right knee felt warmer than other knee and ankle had swelling were added.Event of pain was updated to pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving and event of extreme swelling was updated to extreme swelling/ right knee was twice the size of the left knee.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 18-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced fever, weight bearing difficulty, joint range of motion decreased, knee swelling, knee pain, knee effusion, joint warmth and ankle swelling.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 the information received on 11-dec-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This unsolicited case from united states was received on 11-dec-2017 from patient.This case concerns a patient (demographics not provided) who received treatment with synvisc one injection and after a latency of 1 day had extreme swelling/ right knee was twice the size of the left knee, pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving, could not put weight on the knee, could not move the right knee, was warm to touch/ right knee felt warmer than other knee; after 4 days had ankle had swelling; after unknown latency had fever of 99.8 and knee drained and missed work.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (dose, indication, batch/lot number and expiration date: not provided).On (b)(6) 2017, after a latency of 1 day, his right knee started swelling, was warm to the touch, could not move the right knee, it hurt, and could not put weight on the knee.He said he called his physician the first time the he experienced the swelling.He said he kept it elevated, iced and used ibuprofen 200 mg 2 tablets daily when needed.He said the swelling was not that back at first.He said he went back to work on (b)(6) 2017 and he had to stand on his feet for 12 hours doing his work.He said after 6:00 pm on the same day, his right knee and right ankle had swollen (onset: (b)(6) 2017; latency: 4 days) and was hurting to bare weight on it.He said, 10 minutes after 7:00 pm on the same day, he went to the emergency room about his knee and ankle symptoms.He said the people in the emergency room asked about his pain from a scale of 1 to 10 and 10 being the highest.He said his pain was between 7 and 8.He said that on (b)(6) 2017 morning, he called his orthopedic surgeon and he was going to schedule a mri because he had not received the synvisc-one recall notice.He said, on (b)(6) 2017, he was called back to the orthopedic surgeon and he drained 110 cc of fluid from his right knee.He said he did not have the mri.He said the orthopedic surgeon told him to ice, elevate, and take ibuprofen 200 mg 2 tablets as needed for the pain and inflammation.He said he had been doing this since and his orthopedic surgeon schedule another visit on (b)(6) 2018 to see if the knee had improved.He said he is recovering and if he is lying down on his couch, his knee does not experience any pain or inflammation but if he is in his car driving he said the right knee pain is like someone sticking him with an ice pick.He said if he stands too long like the 12 hours at work he would experience pain and swelling.He is still recovering from his symptoms.On an unknown date in 2017, after an unknown latency, patient's temperature was 99.8 and his right knee felt warmer than other knee.Patient now had approximately dollars (b)(6) in lost income from missed work and would like to know how you plan to reimburse this.Corrective treatment: knee drained; ice; elevated ; ibuprofen for extreme swelling/ right knee was twice the size of the left knee; ice; elevated ; ibuprofen for pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving; 110 cc of fluid drained for knee drained; ice for warm to touch/ right knee felt warmer than other knee; not reported for rest outcome: unknown for missed work; recovering for rest events seriousness criteria: important medical event for device malfunction.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.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.Additional information was received on 11-dec-2017 and 18-dec-2017 from the patient (both processed with the clock start date of 11-dec-2017).Events of device malfunction, fever of 99.8, could not put weight on the knee, could not move the right knee, warm to touch/ right knee felt warmer than other knee and ankle had swelling were added.Event of pain was updated to pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving and event of extreme swelling was updated to extreme swelling/ right knee was twice the size of the left knee.Clinical course was updated and text amended accordingly.Additional information was received on 21-dec-2017.Event of missed work was added along with its details.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 21-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced fever, weight bearing difficulty, joint range of motion decreased, knee swelling, knee pain, knee effusion, joint warmth, inability to work and ankle swelling.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 information received on 06-apr-2018, the case was medically confirmed.Based on the information received on 11-dec-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This unsolicited case from united states was received on (b)(6) 2017 from patient.This case concerns a patient (demographics not provided) who received treatment with synvisc one injection and after a latency of 1 day had extreme swelling/ right knee was twice the size of the left knee, pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving, could not put weight on the knee, could not move the right knee, was warm to touch/ right knee felt warmer than other knee; after 4 days had ankle had swelling; after unknown latency had fever of 99.8 and knee drained and missed work.Also, device malfunction was identified for the reported lot number.No past drug, concomitant medication and concurrent condition was provided.Patient had a history of headache, hematoma, clavical fracture, asthma, left back pain, fall, injury, scrapped left knee, scrapped abdomen, burn to right thumb, right elbow pain, contusion right hand, acute thoracic pain, twisted right knee, discomfort to knee, right knee pain, increased swelling to the knee, acute right knee sprain, suprapatellar joint space effusion, flu virus vaccine allergy.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, once (dose, indication and expiration date: not provided) with batch lot number 7rsl021.On (b)(6) 2017, after a latency of 1 day, his right knee started swelling, was warm to the touch, could not move the right knee, it hurt, and could not put weight on the knee.He said he called his physician the first time the he experienced the swelling.He said he kept it elevated, iced and used ibuprofen 200 mg 2 tablets daily when needed.He said the swelling was not that back at first.He said he went back to work on (b)(6) 2017 and he had to stand on his feet for 12 hours doing his work.He said after 6:00 pm on the same day, his right knee and right ankle had swollen (onset: (b)(6) 2017; latency: 4 days) and was hurting to bare weight on it.He said, 10 minutes after 7:00 pm on the same day, he went to the emergency room about his knee and ankle symptoms.He said the people in the emergency room asked about his pain from a scale of 1 to 10 and 10 being the highest.He said his pain was between 7 and 8.On (b)(6) 2017, 4 days after initiating treatment, patient developed sodium decreased, potassium decreased, anion gap decreased, glucose increased, c reactive protein increased and edema of lower extremities.He said that on (b)(6) 2017 morning, he called his orthopedic surgeon and he was going to schedule a mri because he had not received the synvisc-one recall notice.He said, on (b)(6) 2017, he was called back to the orthopedic surgeon and he drained 110 cc of fluid from his right knee.He said he did not have the mri.He said the orthopedic surgeon told him to ice, elevate, and take ibuprofen 200 mg 2 tablets as needed for the pain and inflammation.He said he had been doing this since and his orthopedic surgeon schedule another visit on (b)(6) 2018 to see if the knee had improved.He said he is recovering and if he is lying down on his couch, his knee does not experience any pain or inflammation but if he is in his car driving he said the right knee pain is like someone sticking him with an ice pick.He said if he stands too long like the 12 hours at work he would experience pain and swelling.He is still recovering from his symptoms.On an unknown date in 2017, after an unknown latency, patient's temperature was 99.8 and his right knee felt warmer than other knee.Patient now had approximately dollars (b)(6) in lost income from missed work and would like to know how you plan to reimburse this.Corrective treatment: knee drained; ice; elevated ; ibuprofen for extreme swelling/ right knee was twice the size of the left knee; ice; elevated ; ibuprofen for pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving; 110 cc of fluid drained for knee drained; ice for warm to touch/ right knee felt warmer than other knee; paracetamol (acetaminophen) and ibuprofen for edema of lower extremities; not reported for rest outcome: unknown for sodium decreased, potassium decreased, anion gap decreased, glucose increased, c reactive protein increased and edema of lower extremities, missed work; recovering for rest events seriousness criteria: important medical event for device malfunction.A pharmaceutical technical complaint (ptc) was initiated with 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 11-dec-2017 and 18-dec-2017 from the patient (both processed with the clock start date of (b)(6) 2017).Events of device malfunction, fever of 99.8, could not put weight on the knee, could not move the right knee, warm to touch/ right knee felt warmer than other knee and ankle had swelling were added.Event of pain was updated to pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving and event of extreme swelling was updated to extreme swelling/ right knee was twice the size of the left knee.Clinical course was updated and text amended accordingly.Additional information was received on 11-dec-2017 and 18-dec-2017 from the patient (both processed with the clock start date of (b)(6) 2017).Events of device malfunction, fever of 99.8, could not put weight on the knee, could not move the right knee, warm to touch/ right knee felt warmer than other knee and ankle had swelling were added.Event of pain was updated to pain/ right knee pain is like someone sticking him with an ice pick/ shooting pains in his right knee when driving and event of extreme swelling was updated to extreme swelling/ right knee was twice the size of the left knee.Clinical course was updated and text amended accordingly.Additional information was received on 21-dec-2017.Event of missed work was added along with its details.Clinical course was updated and text amended accordingly.Follow up was received on 30-jan-2018.Global ptc number was added.Additional information was received on 06-apr-2018 from physician.Additional events of sodium decreased, potassium decreased, anion gap decreased, glucose increased, c reactive protein increased and edema of lower extremities.History added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 06-apr-2018: the follow up information does not change the previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced suicidal behavior, fever, weight bearing difficulty, joint range of motion decreased, knee swelling, knee pain, knee effusion, joint warmth, inability to work and ankle swelling.A temporal relationship of events can be established with the product administration and can not be established for event suicidal behavior.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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Search Alerts/Recalls
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