| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Pain (1994); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
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| Event Date 11/03/2017 |
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Event Type
Injury
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Event Description
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Knee pain; worsened by standing and walking [difficulty in standing], difficulty walking [walking difficulty], limited rom [joint range of motion decreased], joint effusion [joint effusion], swelling located in patella, suprapatellar area [knee swelling], knee pain; worsened by standing and walking [knee pain], mild chondrocaicinosis [chondrocalcinosis], patellar chondromalacia [chondromalacia of patella], red blood cell count decreased [red blood cell count decreased], mch high [mean cell haemoglobin increased], white blood cell count decreased [white blood cell count decreased], red cell distribution width decreased [red cell distribution width decreased], creatinine increased [creatinine increased], glomerular filtration rate low [gfr decreased], a/g ratio decreased [albumin globulin ratio decreased], hdl-cholesterol increased [high density lipoprotein cholesterol increased], ldl increased [ldl increased], bun/ creatinine ratio increased [blood urea nitrogen/creatinine ratio increased], dizziness [dizziness], inr decreased [inr decreased], ptt decreased [partial thromboplastin time shortened], residual weakness [weakness], cholesterol increased [cholesterol blood increased], need assistance for all activities [activities of daily living impaired], skin warm and dry [skin warm], skin warm and dry [skin dry].Case narrative: initial information received on 07-aug-2018 form united states regarding an unsolicited valid serious case received from a healthcare professional this case involves a (b)(6) female patient who experienced knee pain; worsened by standing and walking, difficulty walking, limited rom, joint effusion, mild chondrocaicinosis, patellar chondromalacia, red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio increased, dizziness, inr decreased, ptt decreased, residual weakness, cholesterol increased, need assistance for all activities, swelling located in patella, suprapatellar area and knee pain; worsened by standing and walking, while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient past medical history included dysarthria, confusional state, cerebrovascular accident, dyspnoea, back pain, pain in extremity, arthralgia, chest pain, hypertension, vitamin d deficiency, myalgia, drug hypersensitivity, drug hypersensitivity with sulfa, nausea, varicose vein, impaired gastric emptying, vitamin b12 deficiency, mitral valve prolapse, neuropathy peripheral, hyperlipidaemia, cataract, cataract operation, mental disorder in 2016, urinary tract infection in 2016, osteoarthritis, hysterectomy, cholecystectomy, red blood cell sedimentation rate increased in 2016, dehydration in 2016, osteoarthritis, patellofemoral pain syndrome in 2016, fall, urticaria and dizziness.The patient's past medical treatment included benzylpenicillin (penicillin), lipitor, crestor, tramadol hydrochloride (ultram) and arthrotec.The patient past vaccination(s) and family history were not provided.On (b)(6) 2017, the patient started using synvisc injection (dose, indication, frequency, batch number: unknown).On the next day, patient returned with knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area, skin warm and dry, and joint effusion.No erythema, laceration, abrasion, ecchymosis or puncture wound was found.On the same day, knee x-ray showed mild chondrocalcinosis and marked patellar chondromalacia along with joint effusion.Lab data on (b)(6) 2018 (after a latency of 6 days) showed red blood cell count was 4.06 m/ul, white blood cell count was 4.60 k/ul, mch was 31.7 pcg, rdw was 11.3%, creatinine was 1.19 mg/dl, gfr was 43 ml/min, a/g ratio was 1.3, hdl-cholesterol was 62 mg/dl, ldl was 124 mg/dl.On (b)(6) 2018 white blood cell count was 5.70 k/ul, red blood cell count was 4.48 m/ul, rdw was 11.9 %, mch was 31.3%, bun/creat.Ratio was 21, blood cholesterol was 204 mg/dl.On (b)(6) 2018, the patient developed an event of a non-serious dizziness 3 months 24 days after starting use of hylan g-f 20 and sodium hyaluronate.On (b)(6) 2018, the lab data revealed a decreased inr of 0.94 and decreased partial thromboplastin time of 21.9 seconds.On (b)(6) 2018 patient underwent left knee replacement after which patient was homebound and was scared to go out without assistance.On an unknown date after an unknown latency patient complained of residual weakness (asthenia) and that she needed assistance for all activities.(b)(6).Final diagnosis was knee pain; worsened by standing and walking, swelling located in patella, suprapatellar area, patellar chondromalacia, mild chondrocaicinosis, joint effusion, limited rom, difficulty walking, knee pain; worsened by standing and walking, cholesterol increased, bun/ creatinine ratio increased, ldl increased, hdl-cholesterol increased, a/g ratio decreased, glomerular filtration rate low, creatinine increased, red cell distribution width decreased, white blood cell count decreased, mch high, red blood cell count decreased, dizziness, ptt decreased, inr decreased, need assistance for all activities and residual weakness.The patient was treated with hydrocodone bitartrate, paracetamol (norco) for arthralgia, ketorolac tromethamine (toradol) for arthralgia and lidocaine (lidocaine) for arthralgia.Patient underwent knee replacement for knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area and joint effusion.No corrective reported for other events outcome: recovered for red blood cell count decreased, white blood cell count decreased, red cell distribution width decreased; not recovered for mch high, creatinine increased, glomerular filtration rate low; unknown for other events seriousness criteria: intervention required for knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area and joint effusion.
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Event Description
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Device malfunction [device malfunction] knee pain; worsened by standing and walking [difficulty in standing] difficulty walking/limping gait [walking difficulty] limited rom [joint range of motion decreased] joint effusion [joint effusion] swelling located in patella, suprapatellar area [knee swelling] knee pain; worsened by standing and walking [knee pain] red blood cell count decreased [red blood cell count decreased] mch high [mean cell haemoglobin increased] white blood cell count decreased [white blood cell count decreased] red cell distribution width decreased [red cell distribution width decreased] creatinine increased [creatinine increased] glomerular filteration rate low [gfr decreased] a/g ratio decreased [albumin globulin ratio decreased] hdl-cholesterol increased [high density lipoprotein cholesterol increased] ldl increased [ldl increased] bun/ creatinine ratio increased [blood urea nitrogen/creatinine ratio increased] cholesterol increased [cholesterol blood increased] mild chondrocaicinosis [chondrocalcinosis] patellar chondromalacia [chondromalacia of patella] dizziness [dizziness] inr decreased [inr decreased] ptt decreased [partial thromboplastin time shortened] residual weakness [weakness] need assistance for all activities [activities of daily living impaired] skin warm and dry [skin warm] skin warm and dry [skin dry] left leg pain [pain legs] case narrative: based on additional information received on (b)(6) 2018, suspect product was updated from synvisc to synvisc one.Initial information received on (b)(6) 2018 form united states regarding an unsolicited valid serious legal case received from a healthcare professional this case involves a 81 years old female patient who experienced knee pain; worsened by standing and walking, difficulty walking/limping gait, limited rom, joint effusion, mild chondrocaicinosis, patellar chondromalacia, red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio increased, dizziness, inr decreased, ptt decreased, residual weakness, cholesterol increased, need assistance for all activities, swelling located in patella, suprapatellar area and knee pain; worsened by standing and walking, left leg pain while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Also device malfunction was reported for the same lot number.The patient past medical history included dysarthria, confusional state, cerebrovascular accident, dyspnoea, lumbago/ lower back pain, pain in extremity, arthralgia (bilateral knee pain), chest pain, hypertension, vitamin d deficiency, myalgia, drug hypersensitivity, drug hypersensitivity with sulfa, nausea, varicose vein, impaired gastric emptying, vitamin b12 deficiency, mitral valve prolapse, neuropathy peripheral, hyperlipidaemia, cataract, cataract operation, mental disorder in 2016, urinary tract infection in 2016, osteoarthritis, joint line tenderness, crepitus, hysterectomy, cholecystectomy, colonoscopy, endoscopy, lumbar laminectomy, red blood cell sedimentation rate increased in 2016, dehydration in 2016, osteoarthritis, patellofemoral pain syndrome in 2016, fall, urticaria and dizziness, knee arthritis, gastroparesis, hyperlipemia, limb swelling, liver disease, lumbar disc herniation, l2-3, lumbar spinal stenosis, rotator cuff tendinitis, right spondylolisthesis, lumbar.Patient was allergic to crestor, lipitor, penicillins and sulfa (sulfonamides).Patient never used alcohol and tobacco.Family history included certain chronic disabling diseases, arthritis and heart disease.The patient's past medical treatment included benzylpenicillin (penicillin), lipitor, crestor, tramadol hydrochloride (ultram) and arthrotec.Concomitant medications included ramipril (altace); acetylsalicylic acid (aspirin), atenolol; diphenhydramine hydrochloride (benadryl); biotin; calcium; domperidone; hydrochlorothiazide, triamterene (dyazide); polycarbophil calcium (fibercon); methylprednisolone (medrol dosepak); melatonin; ramipril; hydrochlorothiazide, triamterene (triamterene and hydrochlorothiazide); cyanocobalamin (vitamin b-12); and vitamin b6.On (b)(6) 2017, the patient received intra-articular synvisc one injection, at a dose of 6 ml, once (lot number: 7rsl021) in left knee for primary osteoarthritis of left knee and knee pain.Patient tolerated the injection well.On the next day, patient returned with knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area, skin warm and dry, and joint effusion.No erythema, laceration, abrasion, ecchymosis or puncture wound was found.On the same day, knee x-ray showed mild chondrocalcinosis and marked patellar chondromalacia along with joint effusion.On (b)(6) 2017, patient complaint of left knee pain that had increased from synvisc one injection.Patient went to the emergency department (ed) due to increasing left leg pain and pain with walking.Patient denied any trauma or injury to the left knee.As of (b)(6) 2017, patient had limping gait, was weight bearing, swelling was present, there was tenderness at medial and lateral joint line.On (b)(6) 2017, patient was hospitalized and lab data showed red blood cell count was 4.06 m/ul, white blood cell count was 4.60 k/ul, mch was 31.7 pcg, rdw was 11.3%, creatinine was 1.19 mg/dl, gfr was 43 ml/min, a/g ratio was 1.3, hdl-cholesterol was 62 mg/dl, ldl was 124 mg/dl.On (b)(6) 2018 white blood cell count was 5.70 k/ul, red blood cell count was 4.48 m/ul, rdw was 11.9 %, mch was 31.3%, bun/creat.Ratio was 21, blood cholesterol was 204 mg/dl.On (b)(6) 2017, patient was discharged.On (b)(6) 2018, the patient developed an event of a non-serious dizziness 3 months 24 days after starting use of hylan g-f 20 and sodium hyaluronate.On (b)(6) 2018, the lab data revealed a decreased inr of 0.94 and decreased partial thromboplastin time of 21.9 seconds, creatinine: 0.92 mg/dl (h) (range: 0.50-0.90) and glomerular filtration rate: 58 ml/min/1.73m2 (l) (range: >60 ml/min/1.73m2).On (b)(6) 2018 patient underwent left knee replacement after which patient was homebound and was scared to go out without assistance.On an unknown date after an unknown latency patient complained of residual weakness (asthenia) and that she needed assistance for all activities.Relevant laboratory test results included: activated partial thromboplastin time shortened - on (b)(6) 2018: 21.9 second albumin globulin ratio - on (b)(6) 2017: 1.3 unk; on (b)(6)2018: 1.7 unk blood cholesterol - on (b)(6) 2018: 204 mg/dl blood creatinine - on (b)(6) 2017: 1.19 mg/dl; on (b)(6) 2018: 0.97 mg/dl blood urea nitrogen/creatinine ratio - on (b)(6) 2018: 21 unk glomerular filtration rate - on (b)(6) 2017: 43 ml/min; on (b)(6) 2018: 55 ml/min high density lipoprotein - on (b)(6) 2017: 62 mg/dl; on (b)(6) 2018: 64 mg/dl international normalised ratio - on (b)(6) 2018: 0.94 unk low density lipoprotein - on (b)(6) 2017: 124 mg/dl; on (b)(6) 2018: 128 mg/dl mean cell haemoglobin - on (b)(6) 2017: 31.7 unk; on (b)(6) 2018: 31.3 unk red blood cell count - on (b)(6) 2017: 4.06 unk; on (b)(6) 2018: 4.48 unk red cell distribution width - on (b)(6) 2017: 11.3 %; on (b)(6) 2018: 11.9 % white blood cell count - on (b)(6) 2017: 4.60 unk; on (b)(6) 2018: 5.70 unk the patient was treated with hydrocodone bitartrate, paracetamol (norco) for arthralgia, ketorolac tromethamine (toradol) for arthralgia and lidocaine (lidocaine) for arthralgia.Patient underwent knee replacement for knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area and joint effusion.No corrective reported for other events outcome: recovered for red blood cell count decreased, white blood cell count decreased, red cell distribution width decreased; not recovered for mch high, creatinine increased, glomerular filteration rate low; unknown for other 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 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: intervention required for knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area and joint effusion; hospitalization for red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio increased additional information was received on (b)(6)2018 from a lawyer.Suspect product was updated from synvisc to synvisc one, dose, frequency, indication and lot number was added.Additional event of device malfunction and pain in left leg was added along with details.Medical history was updated, family history was added.Concomitant medications were added.Investigation summary was added.Upon internal review red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio increased were updated to serious and hospitalization dates were added.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] knee pain; worsened by standing and walking [difficulty in standing] difficulty walking/limping gait [walking difficulty] limited rom [joint range of motion decreased] joint effusion [joint effusion] swelling located in patella, suprapatellar area [knee swelling] knee pain; worsened by standing and walking [knee pain] red blood cell count decreased [red blood cell count decreased] mch high [mean cell haemoglobin increased] white blood cell count decreased [white blood cell count decreased] red cell distribution width decreased [red cell distribution width decreased] creatinine increased [creatinine increased] glomerular filteration rate low [gfr decreased] a/g ratio decreased [albumin globulin ratio decreased] hdl-cholesterol increased [high density lipoprotein cholesterol increased] ldl increased [ldl increased] bun/ creatinine ratio increased [blood urea nitrogen/creatinine ratio increased] cholesterol increased [cholesterol blood increased] mild chondrocaicinosis [chondrocalcinosis] patellar chondromalacia [chondromalacia of patella] dizziness [dizziness] inr decreased [inr decreased] ptt decreased [partial thromboplastin time shortened] residual weakness [weakness] need assistance for all activities [activities of daily living impaired] skin warm and dry [skin warm] skin warm and dry [skin dry] left leg pain/pain in extremity [pain legs] tenderness and mild swelling located in the patella, suprapatellar area and medial joint line [tenderness] pain [pain] tenderness and mild swelling located in the patella, suprapatellar area and medial joint line/swelling from the upper calf to the mid-thigh area [swelling of limbs] erythema and warmth from the upper calf to the mid-thigh area [localised feeling of warmth] erythema and warmth from the upper calf to the mid-thigh area [localized erythema] contracture of left knee [contracture of joint] case narrative: based on additional information received on 02-oct-2018, suspect product was updated from synvisc to synvisc one.Initial information received on 07-aug-2018 form united states regarding an unsolicited valid serious legal case received from a healthcare professional this case involves a 81 years old female patient who experienced knee pain; worsened by standing and walking, difficulty walking/limping gait, limited rom, joint effusion, swelling located in patella, suprapatellar area and knee pain; worsened by standing and walking, mild chondrocaicinosis, patellar chondromalacia, skin warm and dry, left leg pain/pain in extremity (latency: 1 day), red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio cholesterol increased (latency: 6 days), dizziness (latency: 3 months 24 days), inr decreased, ptt decreased (latency: 4 months 10 days), residual weakness, need assistance for all activities, contracture of left knee, erythema and warmth from the upper calf to the mid-thigh area, tenderness and mild swelling located in the patella, suprapatellar area and medial joint line/swelling from the upper calf to the mid-thigh area, pain (latency: unknown) while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Also device malfunction was reported for the same lot number.The patient past medical history included dysarthria, confusional state, cerebrovascular accident, dyspnoea, lumbago/ lower back pain, pain in extremity, arthralgia (bilateral knee pain), chest pain, hypertension, vitamin d deficiency, myalgia, drug hypersensitivity, drug hypersensitivity with sulfa, nausea, varicose vein, impaired gastric emptying, vitamin b12 deficiency, mitral valve prolapse, neuropathy peripheral, hyperlipidaemia, cataract, cataract operation, mental disorder in 2016, urinary tract infection in 2016, osteoarthritis, joint line tenderness, crepitus, hysterectomy, cholecystectomy, colonoscopy, endoscopy, lumbar laminectomy, red blood cell sedimentation rate increased in 2016, dehydration in 2016, osteoarthritis, patellofemoral pain syndrome in 2016, metabolic encephalopathy in 2016, anemia, left labrum tear in the hip, s/p discectomy (jun-2016), ischemic colitis (2010), fall, urticaria and dizziness, knee arthritis, gastroparesis, hyperlipemia, limb swelling, liver disease, lumbar disc herniation, l2-3, lumbar spinal stenosis, rotator cuff tendinitis, right spondylolisthesis, lumbar.Patient was allergic to crestor, lipitor, penicillins and sulfa (sulfonamides).Patient never used alcohol and tobacco.Family history included certain chronic disabling diseases, arthritis and heart disease.The patient's past medical treatment included benzylpenicillin (penicillin), lipitor, crestor, tramadol hydrochloride (ultram) and arthrotec.Concomitant medications included ramipril (altace); acetylsalicylic acid (aspirin), atenolol; diphenhydramine hydrochloride (benadryl); biotin; calcium; domperidone; hydrochlorothiazide, triamterene (dyazide); polycarbophil calcium (fibercon); methylprednisolone (medrol dosepak); melatonin; ramipril; hydrochlorothiazide, triamterene (triamterene and hydrochlorothiazide); cyanocobalamin (vitamin b-12); cortisone and vitamin b6.On (b)(6) 2017 , the patient received intra-articular hylan g-f 20, sodium hyaluronate injection, at a dose of 6 ml, once (lot number: 7rsl021) in left knee for primary osteoarthritis of left knee and knee pain.Patient tolerated the injection well.On the same day, patient had lower extremity pain and had been constant worsened by standing and walking.On the next day, patient returned with knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area, skin warm and dry, and joint effusion (latency: 1 day).No erythema, laceration, abrasion, ecchymosis or puncture wound was found.On the same day, knee x-ray showed mild chondrocalcinosis and marked patellar chondromalacia along with moderate left joint effusion.Patient appeared to be in pain, skin was warm and dry and there was moderate tenderness and mild swelling located in the patella, suprapatellar area and medial joint line.Limited rom secondary to pain (diminished flexion, extension and external and internal rotation).On (b)(6) 2017 , patient complaint of left knee pain that had increased from synvisc one injection.Patient went to the emergency department (ed) due to increasing left leg pain and pain with walking.Patient denied any trauma or injury to the left knee.Patient stated that pain had improved.As of 07-nov-2017, patient had limping gait, was weight bearing, swelling was present, there was tenderness at medial and lateral joint line.On (b)(6) 2017 , patient was hospitalized and lab data showed red blood cell count was 4.06 m/ul, white blood cell count was 4.60 k/ul, mch was 31.7 pcg, rdw was 11.3%, creatinine was 1.19 mg/dl, gfr was 43 ml/min, a/g ratio was 1.3, hdl-cholesterol was 62 mg/dl, ldl was 124 mg/dl.On 09-feb-2018 white blood cell count was 5.70 k/ul, red blood cell count was 4.48 m/ul, rdw was 11.9 %, mch was 31.3%, bun/creat.Ratio was 21, blood cholesterol was 204 mg/dl.On (b)(6) 2017, patient was discharged.On (b)(6) 2017, patient reported of having knee problems, especially the left.Patient reported that she got a rather extensive reaction to hylan g-f 20, sodium hyaluronate with swelling, erythema and warmth from the upper calf to the mid-thigh area (latency: unknown).She had to go to the e.F.They gave her pain medication.She couldn't walk.It's gradually getting better.She wants to give it about 6 weeks, until the first of the year, before she considers any surgery.We discussed at length today about knee replacements.She already had a contracture of the left knee (latency: unknown) and we discussed that it will make her therapy more pro1onged and painful.On (b)(6) 2018, the patient developed an event of a non-serious dizziness 3 months 24 days after starting use of hylan g-f 20 and sodium hyaluronate.On(b)(6) 2018, the lab data revealed a decreased inr of 0.94 and decreased partial thromboplastin time of 21.9 seconds, creatinine: 0.92 mg/dl (h) (range: 0.50-0.90) and glomerular filtration rate: 58 ml/min/1.73m2 (l) (range: >60 ml/min/1.73m2).On (b)(6) 2018 patient underwent left knee replacement after which patient was homebound and was scared to go out without assistance.On an unknown date after an unknown latency patient complained of residual weakness (asthenia) and that she needed assistance for all activities.Relevant laboratory test results included: activated partial thromboplastin time shortened - on (b)(6) 2018: 21.9 second albumin globulin ratio - on (b)(6) 2017: 1.3 unk; on 09-feb-2018: 1.7 unk blood cholesterol - on (b)(6) 2018: 204 mg/dl blood creatinine - on (b)(6) 2017: 1.19 mg/dl; on (b)(6) 2018: 0.97 mg/dl blood urea nitrogen/creatinine ratio - on (b)(6) 2018: 21 unk glomerular filtration rate - on (b)(6) 2017: 43 ml/min; on (b)(6) 2018: 55 ml/min high density lipoprotein - on(b)(6) 2017: 62 mg/dl; on (b)(6) 2018: 64 mg/dl international normalised ratio - on (b)(6) 2018: 0.94 unk low density lipoprotein - on (b)(6) 2017: 124 mg/dl; on (b)(6) 2018: 128 mg/dl mean cell haemoglobin - on (b)(6) 2017: 31.7 unk; on (b)(6) 2018: 31.3 unk red blood cell count - on (b)(6) 2017: 4.06 unk; on (b)(6) 2018: 4.48 unk red cell distribution width - on (b)(6) 2017: 11.3 %; on (b)(6) 2018: 11.9 % white blood cell count - on (b)(6) 2017: 4.60 unk; on (b)(6) 2018: 5.70 unk the patient was treated with hydrocodone bitartrate, paracetamol (norco) for arthralgia, ketorolac tromethamine (toradol) for arthralgia and lidocaine (lidocaine) for arthralgia.Patient underwent knee replacement for knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area and joint effusion, use a walker for difficulty walking/limping gait, use of ice for joint effusion; no corrective reported for other events outcome: recovered for red blood cell count decreased, white blood cell count decreased, red cell distribution width decreased; not recovered for mch high, creatinine increased, glomerular filteration rate low; unknown for other 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 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: intervention required for knee pain; worsened by standing and walking, limited rom, difficulty walking (gait disturbance), swelling located in patella, suprapatellar area and joint effusion; hospitalization for red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio increased; disability for difficulty walking/limping gait.Additional information was received on (b)(6) 2018 from a lawyer.Suspect product was updated from synvisc to synvisc one, dose, frequency, indication and lot number was added.Additional event of device malfunction and pain in left leg was added along with details.Medical history was updated, family history was added.Concomitant medications were added.Investigation summary was added.Upon internal review red blood cell count decreased, mch high, white blood cell count decreased, red cell distribution width decreased, creatinine increased, glomerular filtration rate low, a/g ratio decreased, hdl-cholesterol increased, ldl increased, bun/ creatinine ratio increased were updated to serious and hospitalization dates were added.Clinical course was updated and text was amended accordingly.Follow up information received on 17-oct-2018.No new information received.Follow up information received on 17-oct-2018.No new information received.Follow up information was received on 13-nov-2018.No significant information was received.Additional information was received on 19-nov-2018 from physician.Medical history was updated.Events of contracture of left knee, erythema and warmth from the upper calf to the mid-thigh area, tenderness and mild swelling located in the patella, suprapatellar area and medial joint line/swelling from the upper calf to the mid-thigh area, pain were added with details.Severity of event joint effusion was updated to moderate.Verbatim of event left leg pain was updated to left leg pain/pain in extremity.Corrective treatment for joint effusion and difficulty walking/limping gait was updated.Clinical course updated.Text amended accordingly.Follow up information received on 26-nov-2018.No new information.
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