| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
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Event Type
Injury
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Event Description
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Had to use crutches on a daily basis because he could not walk without them [difficulty in walking], loss of strength on left leg [lower extremities weakness of], numbness on left leg [numbness in leg], tingling sensation on left leg [tingling of extremity], foreign body sensation in the left knee [foreign body in knee], left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one [aching (l) knee] ([pain upon movement]) left knee swelling/knee is swollen but it is not warm [swelling of l knee].Case narrative: based upon additional information received on 24-oct-2019, this case initially assessed as non serious was upgraded to serious as event of had to use crutches on a daily basis because he could not walk without them was added which led to disability.Initial information received on 13-jun-2019 regarding an unsolicited valid serious case received from a patient from portugal.This case involves a (b)(6) years old male patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and after unknown latency experienced had to use crutches on a daily basis because he could not walk without them, loss of strength on left leg, foreign body sensation in left knee, numbness on left leg, tingling sensation on left leg, left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one and left knee swelling/knee is swollen but it is not warm after 12 days.The patient's past medical history included crutch user.No medical treatment(s), vaccination(s) and family history were provided.For some years the patient had been suffering from knees pain due to cartilage problems.The pain was higher in the right knee than the pain in the left knee.The patient had a tendency to allergic reactions, in particular, to anti-inflammatory and penicillin.He had skin and respiratory disorders.He was diagnosed with bursitis on his right knee on the unknown date of (b)(6) 2019.Concomitant medications included cyclobenzaprine hydrochloride (flexiban) for pain; cyclobenzaprine for pain; estazolam (kainever) and estazolam.On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate, 1 df, once in left knee (lot - unknown) for knee cartilage problem.Information on batch number was requested.Two weeks later, on an unknown date in (b)(6) 2019, after the viscossupplementation, the patient had much more pain than he ever had.At the moment he was worse of the left knee (the best knee) than the right knee.The patient went to the hospital emergency and was told to apply ice and rest.On (b)(6) 2019 this treatment was not working because the pain did not decrease and he had the knee slightly swollen but without signs of inflammation.On (b)(6) 2019, the patient although had pain during the night, woke up better in regards to the knee pain but he still had foreign body sensation.On (b)(6) 2019, knee was swollen but it was not warm.Patient confirmed that he has more pain now than before the administration of synvisc one.The patient had started again the hydrotherapy after a week and a day of administration and the difficulty with the left knee was greater than the right knee which was not the case before the administration of synvisc one.On unknown date in 2019, after unknown latency, patient started to experience burning sensation on his left knee and the pain increased with movement.As of unknown date in 2019, pain increased when he walked and he drove.Patient mentioned he had to use crutches on a daily basis because he could not walk without them (latency: unknown), for approximately one and a half month when his symptoms were at their worst, he did not remember the exact dates.This event was assessed as serious and was leading to disability.As of (b)(6) 2019, it was reported that the patient checked in with his physician and was advised to apply ice locally and take anti-inflammatory drugs.Patient was also instructed to go to the hospital's emergency department in case he developed fever (which he did not have).Patient reported that events were still ongoing and he was not recovering.On (b)(6) 2019, patient had consultation with the orthopedist who administered him intra-articular hylan g-f 20, sodium hyaluronate injection.He was advised to apply ice locally and took anti-inflammatory drugs (etoricoxib).On the unknown date in 2019, he reported that he continued with pain which increased with movement.As of (b)(6) 2019, it was reported that the patient had not yet recovered from all reactions.He continued with pain in rest and movement.On an unknown date in 2019, after unknown latency patient had loss of strength on left leg, numbness on left leg, tingling sensation on left leg which appeared intermittently.It was reported that patient still did not note the significant improvement, some days, he felt better, somedays worse again.Patient continued to take the previously reported medications.But the anti-inflammatory drugs, he was not taking continuously, because he was afraid of side effects.On an unknown date in 2019, a month and half ago, ultrasound was performed which revealed no fluids in the joints to drain.It was also reported that patient had stopped using crutches because his physician told him to as he should not stop moving his leg permanently.On (b)(6) 2019, patient had an mri of left knee which revealed knee cap with type 3 wiberg morphology with no changes of the patellofemoral ratio.There was however some edema of the more external distal 10 mm of the knee cap due to chondropathy grade 1 in scale of outerbridge.The pre-patellar region and knee cap tendon revealed no changes.There was no evidence of changes equally in the lateral or crossed ligaments of the knee and meniscus presented normal characteristics.There was slight synovial effusion in an amount that, however did not pass the physiologic limit.The knee cap tendon characteristics were normal, no baker cysts and evidence of osteochondral lesions was noticed.On 24-oct-2019, it was reported that the patient was gradually recovering from all the events he experienced after the injection and was now able to do his normal daily routine as he would prior to receiving the hylan g-f 20, sodium hyaluronate injection.The patient however mentioned that his joint did not have the same level of functionality as before the administration, but it was getting closer to that.On (b)(6) 2019, patient was scheduled to begin his physical therapy and he stated that he expected full recovery after the therapy.Action taken: not applicable for all events corrective treatment: local ice application and resting for foreign body sensation in left knee, ice, rest and anti-inflammatory drugs for left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one and left knee swelling/knee is swollen but it is not warm and pain; etoricoxib (exxiv) for left knee swelling/knee is swollen but it is not warm; crutches for had to use crutches on a daily basis because he could not walk without them; none for rest events outcome: recovering/resolving for all of the events a product technical complaint was initiated on 24-jun-2019 for synvisc one.Batch number: unknown global ptc number: (b)(4) the product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation completion date: 24-jun-2019 additional information was received on 21-jun-2019 from patient.Additional event of has a bursitis on his right knee added with details.Additional event of pain increases with movement/pain increases when he walks and he drives added as symptom of left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one.Outcome of left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one updated from recovering to not recovered.Event verbatim of left knee pain updated to left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one; verbatim of left knee swelling updated to left knee swelling/knee is swollen but it is not warm.Clinical course updated.Text amended accordingly.Additional information received on 24-jun-2019.Investigation summary received and ptc results added.Additional information was received on 01-jul-2019 from patient.Outcome of the pain increases with movement/pain increases when he walks and he drives was updated from unknown to not recovered.Information regarding ongoing of events was added.Clinical course updated.Text amended accordingly.Additional information was received on 08-jul-2019 from the patient.Event of has a bursitis on his right knee was updated as medical history.Corrective treatment was updated.Clinical course updated.Text amended accordingly.Additional information was received on 24-jul-2019 from the patient.Information regarding the ongoing status of events was added.Event onset date of joint swelling was updated to 15-jun-2019.Clinical course updated.Text amended accordingly.Additional information was received on 24-sep-2019 from the patient.Events of loss of strength on left leg, numbness on left leg, tingling sensation on left leg added.Medical history added.Clinical course updated, and text amended accordingly.Additional information received on 24-oct-2019 and 26-oct-2019 (processed together with csd of 24-oct-2019) from patient.Case upgraded to serious.Outcome updated to recovering for events of foreign body sensation in left knee, loss of strength on left leg, numbness on left leg, tingling sensation on left leg, left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one and left knee swelling/knee is swollen but it is not warm.Event of loss of strength on left leg updated to a diagnosis.Event of had to use crutches on a daily basis because he could not walk without them added.Lab results of mri added.Clinical course updated.Text amended accordingly.
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Event Description
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Had to use crutches on a daily basis because he could not walk without them [difficulty in walking].Loss of strength on left leg [lower extremities weakness of] numbness on left leg [numbness in leg].Tingling sensation on left leg [tingling of extremity].Foreign body sensation in the left knee [sensation of foreign body].Left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one [aching (l) knee] ([device use error], [pain upon movement]) left knee swelling/knee is swollen but it is not warm [swelling of l knee].Case narrative: based upon additional information received on 24-oct-2019, this case initially assessed as non serious was upgraded to serious as event of had to use crutches on a daily basis because he could not walk without them was added which led to disability.Initial information received on 13-jun-2019 regarding an unsolicited valid serious case received from a patient from portugal.This case involves a 33 years old male patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced had to use crutches on a daily basis because he could not walk without them, loss of strength on left leg, foreign body sensation in left knee, numbness on left leg, tingling sensation on left leg (latency: unknown), left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one (latency: two weeks) and left knee swelling/knee is swollen but it is not warm (latency: 12 days).The patient's past medical history included crutch user.No medical treatment(s), vaccination(s) and family history were provided.For some years the patient had been suffering from knees pain due to cartilage problems.The pain was higher in the right knee than the pain in the left knee.The patient had a tendency to allergic reactions, in particular, to anti-inflammatory and penicillin.He had skin and respiratory disorders.He was diagnosed with bursitis on his right knee on the unknown date on (b)(6) 2019.Concomitant medications included cyclobenzaprine hydrochloride (flexiban) for pain; cyclobenzaprine for pain; estazolam (kainever) and estazolam.Before the administration of hylan g-f 20, sodium hyaluronate, patient had knee inflammation.On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate, 1 df, once in left knee (lot - unknown) for knee cartilage problem.Information on batch number was requested.Patient mentioned that time of hylan g-f 20, sodium hyaluronate administration no previous exam was performed on his knee, and no procedure was performed to withdraw the damaged synovial fluid from the knee neither to reduce knee inflammation which was already there before administration.Two weeks later, on an unknown date on (b)(6) 2019, after the viscossupplementation, the patient had much more pain than he ever had.At the moment he was worse of the left knee (the best knee) than the right knee.The patient went to the hospital emergency and was told to apply ice and rest.On (b)(6) 2019 this treatment was not working because the pain did not decrease and he had the knee slightly swollen but without signs of inflammation.On (b)(6) 2019, the patient although had pain during the night, woke up better in regards to the knee pain but he still had foreign body sensation.On (b)(6) 2019, knee was swollen but it was not warm.Patient confirmed that he has more pain now than before the administration of hylan g-f 20, sodium hyaluronate.The patient had started again the hydrotherapy after a week and a day of administration and the difficulty with the left knee was greater than the right knee which was not the case before the administration of hylan g-f 20, sodium hyaluronate.On unknown date in 2019, after unknown latency, patient started to experience burning sensation on his left knee and the pain increased with movement.As of unknown date in 2019, pain increased when he walked and he drove.Patient mentioned he had to use crutches on a daily basis because he could not walk without them (latency: unknown), for approximately one and a half month when his symptoms were at their worst, he did not remember the exact dates.This event was assessed as serious and was leading to disability.As of on (b)(6) 2019, the patient checked in with his physician and was advised to apply ice locally and take anti-inflammatory drugs.Patient was also instructed to go to the hospital's emergency department in case he developed fever (which he did not had).Patient reported that events were still ongoing and he was not recovering.On (b)(6) 2019, patient had consultation with the orthopedist who administered him intra-articular hylan g-f 20, sodium hyaluronate injection.He was advised to apply ice locally and took anti-inflammatory drugs (etoricoxib).On the unknown date in 2019, he reported that he continued with pain which increased with movement.As of on (b)(6) 2019, it was reported that the patient had not yet recovered from all reactions.He continued with pain in rest and movement.On an unknown date in 2019, after unknown latency patient had loss of strength on left leg, numbness on left leg, tingling sensation on left leg which appeared intermittently.It was reported that patient still did not note the significant improvement, some days, he felt better, some days worse again.Patient continued to take the previously reported medications.But the anti-inflammatory drugs, he was not taking continuously, because he was afraid of side effects.On an unknown date in 2019, a month and half ago, ultrasound was performed which revealed no fluids in the joints to drain.It was also reported that patient had stopped using crutches because his physician told him to as he should not stop moving his leg permanently.On (b)(6) 2019, patient had an mri of left knee which revealed knee cap with type 3 wiberg morphology with no changes of the patellofemoral ratio.There was however some edema of the more external distal 10 mm of the knee cap due to chondropathy grade 1 in scale of outerbridge.The pre-patellar region and knee cap tendon revealed no changes.There was no evidence of changes equally in the lateral or crossed ligaments of the knee and meniscus presented normal characteristics.There was slight synovial effusion in an amount that, however did not pass the physiologic limit.The knee cap tendon characteristics were normal, no baker cysts and evidence of osteochondral lesions was noticed.On (b)(6) 2019, it was reported that the patient was gradually recovering from all the events he experienced after the injection and was now able to do his normal daily routine as he would prior to receiving the hylan g-f 20, sodium hyaluronate injection.The patient however mentioned that his joint did not have the same level of functionality as before the administration, but it was getting closer to that.On (b)(6) 2019, patient was scheduled to begin his physical therapy and he stated that he expected full recovery after the therapy.On (b)(6) 2019, the patient reported that the events were still not completely resolved.Patient was advised to seek medical advice from a specialist on the knee.Action taken: not applicable for all events.Corrective treatment: local ice application and resting for foreign body sensation in left knee, ice, rest and anti-inflammatory drugs for left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one and left knee swelling/knee is swollen but it is not warm and pain; etoricoxib (exxiv) for left knee swelling/knee is swollen but it is not warm; crutches for had to use crutches on a daily basis because he could not walk without them; none for rest events.Outcome: recovering/resolving for all of the events.A product technical complaint was initiated on 24-jun-2019 for synvisc one.Batch number: unknown global ptc number: 59050.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation completion date: 24-jun-2019.Additional information was received on (b)(6) 2019 from patient.Additional event of has a bursitis on his right knee added with details.Additional event of pain increases with movement/pain increases when he walks and he drives added as symptom of left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one.Outcome of left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one updated from recovering to not recovered.Event verbatim of left knee pain updated to left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one; verbatim of left knee swelling updated to left knee swelling/knee is swollen but it is not warm.Clinical course updated.Text amended accordingly.Additional information received on 24-jun-2019.Investigation summary received and ptc results added.Additional information was received on (b)(6) 2019 from patient.Outcome of the pain increases with movement/pain increases when he walks and he drives was updated from unknown to not recovered.Information regarding ongoing of events was added.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2019 from the patient.Event of has a bursitis on his right knee was updated as medical history.Corrective treatment was updated.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2019 from the patient.Information regarding the ongoing status of events was added.Event onset date of joint swelling was updated to on (b)(6) 2019.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2019 from the patient.Events of loss of strength on left leg, numbness on left leg, tingling sensation on left leg added.Medical history added.Clinical course updated, and text amended accordingly.Additional information received on (b)(6) 2019 (processed together with csd on (b)(6) 2019) from patient.Case upgraded to serious.Outcome updated to recovering for events of foreign body sensation in left knee, loss of strength on left leg, numbness on left leg, tingling sensation on left leg, left knee pain/left knee burning sensation/has more pain now than before the administration of synvisc one and left knee swelling/knee is swollen but it is not warm.Event of loss of strength on left leg updated to a diagnosis.Event of had to use crutches on a daily basis because he could not walk without them added.Lab results of mri added.Clinical course updated.Text amended accordingly.Additional information received on (b)(6) 2019 from patient and on (b)(6) 2019 from patient via medical affairs (processed together with clock start date of 27-dec-2109).Medical history was updated.Clinical course updated.Text amended accordingly.
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