| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
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| Event Date 12/07/2017 |
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Event Type
Injury
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Event Description
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Based on additional information received on 06-feb- 2018, this case initially considered as non-serious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site).This unsolicited case from united states was received on 02-jan-2018 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had difficulty ambulating/ walking less due to pain, losing sleep, more pain (latency 1 day) and had difficulty weight bearing, redness, warmth, increased swelling at site.Also, device malfunction was identified for the reported lot number.Relevant medical history included gastroesophageal reflux disease, heart disease.Relevant concurrent condition included hypertension.Relevant concomitant medication included dexlansoprazole (dexilant) foe gerd, amlodipine besilate (norvasc) as calcium blocker, paracetamol (tylenol) for pain/fever, cyclobenzaprine hydrochloride (flexeril) for muscle spasm, hydrochlorothiazide/valsartan (diovan hct) for hypertension.The patient was allergic to morphineanxiety, sweating.On (b)(6) 2017, patient's culture- gram/anaerobe showed no growth, synovial fluid analysis showed no crystals, <2 protein and cell count showed normal rbc 150 nucleated cells.It was reported that the patient consulted the healthcare professional by telephone and saw him in person on (b)(6) 2017.The patient did not visit the emergency room and was not admitted to the hospital.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: 48 mg/6 ml) for pain in knee and osteoarthritis (lot number: 7rsloz1; expiration date: may-2020).On an unknown date in 2017, after unknown latency, the patient had difficulty ambulating.It was reported that the patient still had pain and difficulty ambulating and was walking "much less" due to the pain.On (b)(6) 2017, 01 day after initiating treatment with alemtuzumab, the patient experienced more pain, redness, warmth, pain, swelling, difficulty weight bearing.He had an appointment to follow up with his doctor on (b)(6) 2018.On an unknown date in 2017, the patient had increased swelling at the site.Since an unknown date in 2017, the patient had been losing sleep due to pain and worry about the infection.It was reported that the patient asked if infection can circulate through his system.He states the injection was placed into left knee and it was not measured before the injection.He stated that he did not feel he should have to pay for the injection or the follow up.He requested reimbursement.Action taken: permanently discontinued.Corrective treatment: knee aspiration, cortisone injection for difficulty weight bearing, redness, warmth, more pain, increased swelling at site; not reported for rest of the events.Outcome: unknown for losing sleep, difficulty ambulating/ walking less due to pain, device malfunction; not recovered/not resolved for difficulty ambulating/ walking less due to pain, more pain, warmth, redness, difficulty weight bearing, increased swelling at site (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 is completed, corrective and preventive actions would be implemented.Additional information was received on 31-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-feb-2018 from the patient.This case initially considered as nonserious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site).Dosing details of the suspect product was updated (dates updated, lot number added, indication updated).Medical history, past drugs, concomitant medications and concurrent conditions were added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 06-feb-2018.This case concerns a patient who presented weight bearing difficulty and device malfunction after receiving treatment with synvisc one.Based upon the information, the causal role of the product cannot be denied with the occurrence of event.However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better assessment of the case.
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Event Description
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Based on additional information received on (b)(6) 2018, this case initially considered as non-serious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site).This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case concerns a 84 years old male patient who received treatment with synvisc one and later after unknown latency had effusion, difficulty ambulating/ walking less due to pain/unable to walk, losing sleep, more pain (latency 1 day) and had difficulty weight bearing, redness, warmth, increased swelling at site/ intermittent swelling.Also, device malfunction was identified for the reported lot number.Relevant medical history included gastroesophageal reflux disease, heart disease.Relevant concurrent condition included hypertension, left knee pain, eye glasses, heart disease, sleep apnea.Relevant concomitant medication included dexlansoprazole (dexilant) foe gerd, amlodipine besilate (norvasc) as calcium blocker, paracetamol (tylenol) for pain/fever, cyclobenzaprine hydrochloride (flexeril) for muscle spasm, hydrochlorothiazide/valsartan (diovan hct) for hypertension and lidocaine hydrochloride (xylocaine), metoprolol succinate (toprol xl), clopidogrel bisulfate (plavix), acetylsalicylic acid (aspirin), linum usitatissimum seed oil (flaxseed oil) and fish oil.The patient was allergic to morphine- anxiety, sweating.On 03-jan-2017, patient's culture-gram/anaerobe showed no growth, synovial fluid analysis showed no crystals, <2 protein and cell count showed normal rbc 150 nucleated cells.It was reported that the patient consulted the healthcare professional by telephone and saw him in person on 03- jan-2017.The patient did not visit the emergency room and was not admitted to the hospital.Immunizations included influenza vaccine (20-nov-2017).Patient had cardiac stents placed in 2004.Patient had primary osteoarthritis of left knee.On 06-dec-2017, patient received gel one joint injection administration in left knee.On 01-dec-2017, patient underwent knee x-ray for left knee pain (6 on scale of 0-10; aggravating factor: sitting and walking, treatment: over the counter medications) and the results were no additional intramedullary lesions were seen.Left knee moderately severe osteoarthritis significant vascular calcification and loose body versus heterotopic ossification seen superior to the patella.It was reported that patient had no specific range of motion issues, got good stability, no significant effusion and had pain posteriorly.He got calf pain and knee pain with ambulation, had significant vascular calcification.The same day, at 10:03 am, patient was seen in consultation for evaluation of left knee pain.Patient has been having pain for 4 months.Pain is rated 8/10 and was described as aching.Pain improved with rest but worse with weight bearing.Patient denied any previous injury to left knee.Patient had no mechanical symptoms, had difficulty with stairs and steps.Patient underwent physical exam; patient's vitals were normal.Patient's left knee exam suggested flexion 122 degrees, extension 0 degrees, negative effusion, point tenderness medial joint line, negative ligamentous laxity with varus/valgus stress, anterior/posterior stress testing: negative, negative medical and lateral mcmurrays, positive crepitus; rest was normal.Patient's review of systems included left knee pain, eye glasses, heart disease, sleep apnea.On 06-dec-2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: 48 mg/6 ml) for pain in left knee and osteoarthritis of left knee (lot number: 7rsl021; expiration date: may-2020).On an unknown date in 2017, after unknown latency, the patient had difficulty ambulating.It was reported that the patient still had pain and difficulty ambulating and was walking "much less" due to the pain.On 07-dec-2017, 01 day after initiating treatment with synvisc one, the patient experienced more pain, redness, warmth, pain, swelling, difficulty weight bearing.It was reported that injection did not help with his pain and believed it made his pain worse.Patient stated that he had increased pain the day after his injection and could barely walk.The pain was located over the anterior knee rated 06 out of 10, had characteristics of aching, sharp, dull and was a constant pain that did not radiate and was aggravated by activity specially walking.Patient did have sharp, stabbing pain occasionally with swelling.Patient stated that he had increased swelling for 1 week after.On an unknown date in 2017, the patient had increased swelling at the site.Since an unknown date in 2017, the patient had been losing sleep due to pain and worry about the infection.It was reported that the patient asked if infection can circulate through his system.He states the injection was placed into left knee and it was not measured before the injection.He stated that he did not feel he should have to pay for the injection or the follow up.He requested reimbursement.On 03-jan-2018, patient received 3 ml of dexamethasone in left knee.Same day, patient was seen and evaluated by doctor and discussed the assessment and plan.Patient complained of increasing pain after viscosupplementation injection 1 months ago.He is having intermittent sharp pains.He is unable to walk and had intermittent swelling.On exam, he was equivocal and benign with good range of motion, pain, more medially.He did have an effusion.As a result of having some issues with a bad lot of viscosupplementation recommended an aspiration today.Patient elected to proceed with aspiration of the left knee with fluid being sent for analysis.Patient's left knee was prepped in a normal sterile fashion and injected with 1 % lidocaine hydrochloride for local anesthesia.15 cc of straw colored fluid was aspirated and sent to lab for cell count and culture.After aspiration (as found to be straw colored), 3 cc of dexamethasone was injected.Patient tolerated procedure well.Patient's knee aspirate bacterial culture (anaerobe) was normal (no anaerobic organisms isolated); bacterial culture other with gram stain: no organisms seen.Patient's synovial fluid was negative for rheumatoid factor and no crystals were seen, proteins were less than 2.0 g/dl, glucose was 100 mg/dl.Synovial fluid was clear and yellow in color, negative for fibrin clot, red blood cells were less than 3000/mcl, mononuclears were 92 %.Fall risk screening was found to be negative.As of 03-jan-2018, pain rating was 07 on scale of 0-10.On 03-jan-2018, patient underwent mri extremity lower joint without contrast left for acute pain of left knee (results pending).Corrective treatment: knee aspiration, cortisone injection for more pain, difficulty weight bearing, redness, warmth, increased swelling at site/intermittent swelling; cortisone injection for effusion; not reported for rest of the events outcome: unknown for effusion, losing sleep, difficulty ambulating/ walking less due to pain/unable to walk, device malfunction; not recovered/not resolved for difficulty ambulating/ walking less due to pain, more pain, warmth, redness, difficulty weight bearing, increased swelling at site/intermittent swelling a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51740 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 is completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site/intermittent swelling, effusion additional information was received on 31-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-feb-2018 from the patient.This case initially considered as nonserious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site).Dosing details of the suspect product was updated (dates updated, lot number added, indication updated).Medical history, past drugs, concomitant medications and concurrent conditions were added.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-feb-2018 and 23-feb-2018 (both the information was processed together with clock start date: (b)(6) 2018).Additional event of effusion and its details were added.Event verbatim of increased swelling at site was updated to increased swelling at site/intermittent swelling.Event verbatim of difficulty ambulating/ walking less due to pain was updated to difficulty ambulating/ walking less due to pain/unable to walk.Concomitant medications of the patient were added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated (b)(6) 2018: the follow-up information does not changes the prior assessment of the case.This case concerns a patient who presented weight bearing difficulty and device malfunction after receiving treatment with synvisc one.Based upon the information, the causal role of the product cannot be denied with the occurrence of event.However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better assessment of the case.
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Event Description
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Device malfunction [device malfunction] , difficulty weight bearing [weight bearing difficulty], redness [injection site joint redness] , warmth [joint warmth] , more pain [knee pain] ([condition aggravated]), effusion [effusion (l) knee], increased swelling at site/intermittent swelling [swelling of l knee], difficulty ambulating/ walking less due to pain/unable to walk [difficulty in walking] , and losing sleep [sleeplessness].Case narrative: based on additional information received on 06-feb-2018, this case initially considered as non-serious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site).This unsolicited case from united states was received on 02-jan-2018 from a patient.This case concerns a 84 years old male patient who received treatment with synvisc one and later after unknown latency had effusion, difficulty ambulating/ walking less due to pain/unable to walk, losing sleep, more pain (latency 1 day) and had difficulty weight bearing, redness, warmth, increased swelling at site/intermittent swelling.Also, device malfunction was identified for the reported lot number.Relevant medical history included gastroesophageal reflux disease, heart disease.Relevant concurrent condition included hypertension, left knee pain, eye glasses, heart disease, sleep apnea.Relevant concomitant medication included dexlansoprazole (dexilant) foe gerd, amlodipine besilate (norvasc) as calcium blocker, paracetamol (tylenol) for pain/fever, cyclobenzaprine hydrochloride (flexeril) for muscle spasm, hydrochlorothiazide/valsartan (diovan hct) for hypertension and lidocaine hydrochloride (xylocaine), metoprolol succinate (toprol xl), clopidogrel bisulfate (plavix), acetylsalicylic acid (aspirin), linum usitatissimum seed oil (flaxseed oil) and fish oil.The patient was allergic to morphine- anxiety, sweating.On (b)(6) 2017, patient's culture-gram/anaerobe showed no growth, synovial fluid analysis showed no crystals, <2 protein and cell count showed normal rbc 150 nucleated cells.It was reported that the patient consulted the healthcare professional by telephone and saw him in person on (b)(6) 2017.The patient did not visit the emergency room and was not admitted to the hospital.Immunizations included influenza vaccine ((b)(6) 2017).Patient had cardiac stents placed in 2004.Patient had primary osteoarthritis of left knee.On (b)(6) 2017, patient received gel one joint injection administration in left knee.On (b)(6) 2017, patient underwent knee x-ray for left knee pain (6 on scale of 0-10; aggravating factor: sitting and walking, treatment: over the counter medications) and the results were no additional intra-medullary lesions were seen.Left knee moderately severe osteoarthritis significant vascular calcification and loose body versus heterotopic ossification seen superior to the patella.It was reported that patient had no specific range of motion issues, got good stability, no significant effusion and had pain posteriorly.He got calf pain and knee pain with ambulation, had significant vascular calcification.The same day, at 10:03 am, patient was seen in consultation for evaluation of left knee pain.Patient has been having pain for 4 months.Pain is rated 8/10 and was described as aching.Pain improved with rest but worse with weight bearing.Patient denied any previous injury to left knee.Patient had no mechanical symptoms, had difficulty with stairs and steps.Patient underwent physical exam; patient's vitals were normal.Patient's left knee exam suggested flexion 122 degrees, extension 0 degrees, negative effusion, point tenderness medial joint line, negative ligamentous laxity with varus/valgus stress, anterior/posterior stress testing: negative, negative medical and lateral mcmurrays, positive crepitus; rest was normal.Patient's review of systems included left knee pain, eye glasses, heart disease, sleep apnea.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: 48 mg/6 ml) for pain in left knee and osteoarthritis of left knee (lot number: 7rsl021; expiration date: (b)(6) 2020).On an unknown date in 2017, after unknown latency, the patient had difficulty ambulating.It was reported that the patient still had pain and difficulty ambulating and was walking "much less" due to the pain.On (b)(6) 2017, 01 day after initiating treatment with synvisc one, the patient experienced more pain, redness, warmth, pain, swelling, difficulty weight bearing.It was reported that injection did not help with his pain and believed it made his pain worse.Patient stated that he had increased pain the day after his injection and could barely walk.The pain was located over the anterior knee rated 06 out of 10, had characteristics of aching, sharp, dull and was a constant pain that did not radiate and was aggravated by activity specially walking.Patient did have sharp, stabbing pain occasionally with swelling.Patient stated that he had increased swelling for 1 week after.On an unknown date in 2017, the patient had increased swelling at the site.Since an unknown date in 2017, the patient had been losing sleep due to pain and worry about the infection.It was reported that the patient asked if infection can circulate through his system.He states the injection was placed into left knee and it was not measured before the injection.He stated that he did not feel he should have to pay for the injection or the follow up.He requested reimbursement.On (b)(6) 2018, patient received 3 ml of dexamethasone in left knee.Same day, patient was seen and evaluated by doctor and discussed the assessment and plan.Patient complained of increasing pain after visco supplementation injection 1 months ago.He is having intermittent sharp pains.He is unable to walk and had intermittent swelling.On exam, he was equivocal and benign with good range of motion, pain, more medially.He did have an effusion.As a result of having some issues with a bad lot of visco supplementation recommended an aspiration today.Patient elected to proceed with aspiration of the left knee with fluid being sent for analysis.Patient's left knee was prepped in a normal sterile fashion and injected with 1 % lidocaine hydrochloride for local anesthesia.15 cc of straw colored fluid was aspirated and sent to lab for cell count and culture.After aspiration (as found to be straw colored), 3 cc of dexamethasone was injected.Patient tolerated procedure well.Patient's knee aspirate bacterial culture (anaerobe) was normal (no anaerobic organisms isolated); bacterial culture other with gram stain: no organisms seen.Patient's synovial fluid was negative for rheumatoid factor and no crystals were seen, proteins were less than 2.0 g/dl, glucose was 100 mg/dl.Synovial fluid was clear and yellow in color, negative for fibrin clot, red blood cells were less than 3000/mcl, mononuclears were 92 %.Fall risk screening was found to be negative.As of (b)(6) 2018, pain rating was 07 on scale of 0-10.On (b)(6) 2018, patient underwent mri extremity lower joint without contrast left for acute pain of left knee (results pending).Corrective treatment: knee aspiration, cortisone injection for more pain, difficulty weight bearing, redness, warmth, increased swelling at site/intermittent swelling; cortisone injection for effusion; not reported for rest of the events.Outcome: unknown for effusion, losing sleep, difficulty ambulating/ walking less due to pain/unable to walk, device malfunction; not recovered/not resolved for difficulty ambulating/ walking less due to pain, more pain, warmth, redness, difficulty weight bearing, increased swelling at site/intermittent swelling.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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site/intermittent swelling, effusion.Additional information was received on 31-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-feb-2018 from the patient.This case initially considered as non-serious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site).Dosing details of the suspect product was updated (dates updated, lot number added, indication updated).Medical history, past drugs, concomitant medications and concurrent conditions were added.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-feb-2018 and 23-feb-2018 (both the information was processed together with clock start date: 22-feb-2018).Additional event of effusion and its details were added.Event verbatim of increased swelling at site was updated to increased swelling at site/intermittent swelling.Event verbatim of difficulty ambulating/ walking less due to pain was updated to difficulty ambulating/ walking less due to pain/unable to walk.Concomitant medications of the patient were added.Clinical course was updated and text amended accordingly.
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