| Lot Number 7RSL021 |
| Device Problems
Nonstandard Device (1420); Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Bruise/Contusion (1754); Erythema (1840); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Chills (2191); Dizziness (2194); Excessive Tear Production (2235); Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); Irritability (2421); Sweating (2444); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Event Description
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Device malfunction [device malfunction], has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait [gait inability], patellofemoral irritability [patellofemoral pain syndrome], knee swelling [knee swelling], right and left knee peripatellar crepitation [joint crepitation], pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness [arthralgia], right knee moderate effusion [effusion (r) knee], some stiffness secondary to swelling [joint stiffness].Case narrative: based on additional information received on 10-may-2018 from a physician, the case was medically confirmed.Also the case initially considered as non-serious was upgraded to serious as an important medical event of device malfunction was added.This case is cross referred with the case (b)(4) (same patient).This unsolicited case from united states was received on 03-jan-2018 from patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and after unknown latency had has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait, had pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness, had right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, right and left knee peripatellar crepitation.Also device malfunction was reported for this lot number.Medical history included bilateral knee arthritis, increasing pain as well as pain at night (pain described as aching, exhausting, miserable, nagging, penetrating, sharp, shooting, tender, throbbing and tiring), worsens with walking/activity, improves with rest, worsens with climbing stairs, worsens with descending stairs, improves with medication (takes edge off but not completely - aleve) and worsens with sleeping, moderate effusion in both knees, baker's cyst in left knee, tricompartmental djd worse in the medial and patellofemoral compartments with degenerative medial meniscal tear in left knee, tricompartmental degenerative joint disease (djd) with edema in the medial tibial plateau, medial femoral condyle and tibial spine with significant patellofemoral degenerative changes and degenerative medial meniscal tear in right knee and diffuse anterior medial knee pain, l tibial plateau treated nonoperatively in 2006, arthroscopy of the right, left knee in 2010 (2014), night sweats, nausea, heartburn, swelling lower extremities, muscle weakness, stiffness and joint pain.The patient previously had fracture repair of the left knee.Other previous surgeries include hysterectomy in 2004.Patient had continued pain, morning stiffness, pain with standing/sitting long periods, pain with walking long periods, recurrent swelling, weakness, tenderness, stiffness and instability, injury.Patient drinks alcohol socially (1-2 drinks per week).She never used tobacco.Patient was allergic to diphenhydramine hydrochloride (benadryl), codeine, minocycline, morphine, penicillins, sulfa (sulfonamides), synvisc, tetracyclines and naproxen (vimovo).Prior treatments included anti-inflammatory (aleve twice a day helps somewhat), cane use (no), brace use (patellar sleeve brace uncomfortable), physical therapy (did not help).Patient had received synvisc one injection before on (b)(6) 2017 in left knee and cortisone in (b)(6) 2017.Family history included asthma in father, coronary artery disease and heart disease in father and grandmother and high cholesterol, hypertension, rheumatoid arthritis, rheumatic fever and kidney disease in mother.On (b)(6) 2017, magnetic resonance imaging (mri) of left knee showed mild osteoarthritis, complex tears in the posterior horn and root of the medial meniscus, mcl and acl strain, large joint effusion, bone contusion in the medial femoral condyle and tibial plateau and large popliteal cyst.On the same day, mri of right knee showed complex tears in the posterior horn, body and root of the medial meniscus, mcl strain, moderate osteoarthritis and chondromalacia patella, large joint effusion and bone contusion in the medial femoral condyle, tibial plateau and proximal mid tibia.A microfracture could not be excluded.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 48 mg (lot number: 7rsl021; frequency and expiry date: not reported) in both knees for osteoarthritis.The patient tolerated the procedure well.Bilateral knees were aspirated 20 cc of clear yellow synovial fluid prior to synvisc-one injections.On (b)(6) 2017, patient was complaining of significant pain with difficulty walking, big swollen knee.She was afebrile.Physical examination of bilateral knees demonstrates antalgic gait and range of motion 10-90 degrees due to pain.Afebrile and 3+ joint effusions stable.2+ distal pulses, intact sensation and motor function, no calf swelling and no edema.Patient reported that the patient walks like a penquin and had never had anything like the experience she was having now.Patient mentioned how much pain she was in.On (b)(6) 2017, x-ray of both knees was done that showed medial joint space narrowing with marginal osteophyte formation, periarticular sclerosis and cysts bilaterally.Right knee showed diffuse global tenderness, effusion, lateral joint line tenderness.There was medial joint line tenderness, peripatellar pain and peripatellar crepitation in both knees.The patient displayed antalgic gait on right and antalgic gait on left.Also there was maculopapular erythematous lesions to bilateral knees, posterior fullness, negative posterior drawer.On (b)(6) 2018, patient complained primarily some pain and persistent swelling in the right knee.Her left knee was doing much better.On the same day, patient's right knee shows moderate effusion.Patient had no erythema, warmth or signs of infection.Patient had some stiffness secondary to swelling.Mild diffuse joint line pain as well as patellofemoral irritability, no calf pain or swelling, negative homans1 sign, mildly antalgic gait.On (b)(6) 2018, after discussion with the patient regarding treatment options, a mutual decision was made to proceed with an aspiration/injection of the right knee joint.The right knee was sterilely prepped, and 30 cc of blood tinged clear synovial fluid.Fluid sent for routine studies including gram stain, cell count, crystals, protein, glucose, anaerobic and aerobic, afb and fungal cultures.The knee was then injected with a mixture of 4 cc 1% lidocaine, 4 cc, 0.25% bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog) 80 mg.The patient tolerated the procedure well; post injection instructions were given.No obvious signs of infection based on fluid aspirate.Patient was reassured that there was no acute need for surgical intervention.Patient was scheduled for follow-up in two to three weeks or sooner should swelling persist or worsen.The patient was also aware to look for signs of infection such as fever, redness, increasing pain, etc.Corrective treatment: aspiration, mixture of 4 cc 1% lidocaine, 4 cc 0.25% marcaine and kenalog 80 mg for right knee moderate effusion; not reported for other events outcome: unknown for all events.A pharmaceutical technical complaint was initiated with (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction.Additional information was received on 09-jan-2018 from the patient.Event of trouble walking was updated to trouble walking/can't walk and having challenges beyond words/walks like a penquin.Event of pain was added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 10-may-2018 from a physician.The case was medically confirmed.The case was upgraded to serious.Patient's demographics were added.Medical history, past drug were added.Additional events of right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, device malfunction right and left knee peripatellar crepitation were added along with details.The event term has trouble walking/can't walk and having challenges beyond words/walks like a penquin was updated to has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait and pain was updated to pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness.Dose, indication and lot number of synvisc one was added.Investigation summary was updated.Related case was added.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] right knee moderate effusion [effusion (r) knee] has trouble walking/can't walk and and having challenges beyond words/walks like a penquin/mildly antalgic gait [gait inability] patellofemoral irritability [patellofemoral pain syndrome] right and left knee peripatellar crepitation [joint crepitation] synovial fluid orange [synovial fluid color] synovial fluid cell count abnormal [synovial fluid cell count] allergic reaction [allergic reaction] knee swelling [knee swelling] pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness [arthralgia] some stiffness secondary to swelling [joint stiffness] case narrative: based on additional information received on 10-may-2018 from a physician, the case was medically confirmed.Also the case initially considered as non-serious was upgraded to serious as an important medical event of device malfunction was added.This case is cross referred with the case 2018sa137461 (same patient).This unsolicited case from united states was received on 03-jan-2018 from patient.This case concerns a 55 years old female patient who received treatment with synvisc one and after unknown latency had has trouble walking/can't walk and and having challenges beyond words/walks like a penquin/mildly antalgic gait, had pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness, had right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, right and left knee peripatellar crepitation and allergic reaction.Also device malfunction was reported for this lot number.Medical history included bilateral knee arthritis, increasing pain as well as pain at night (pain described as aching, exhausting, miserable, nagging, penetrating, sharp, shooting, tender, throbbing and tiring), worsens with walking/activity, improves with rest, worsens with climbing stairs, worsens with descending stairs, improves with medication (takes edge off but not completely - aleve) and worsens with sleeping, moderate effusion in both knees, baker's cyst in left knee, tricompartmental djd worse in the medial and patellofemoral compartments with degenerative medial meniscal tear in left knee, tricompartmental degenerative joint disease (djd) with edema in the medial tibial plateau, medial femoral condyle and tibial spine with significant patellofemoral degenerative changes and degenerative medial meniscal tear in right knee and diffuse anterior medial knee pain, l tibial plateau treated nonoperatively in 2006, arthroscopy of the right, left knee in 2010 (2014), night sweats, nausea, heartburn, swelling lower extremities, muscle weakness, stiffness and joint pain.The patient previously had fracture repair of the left knee.Other previous surgeries include hysterectomy in 2004.Patient had continued pain, morning stiffness, pain with standing/sitting long periods, pain with walking long periods, recurrent swelling, weakness, tenderness, stiffness and instability, injury.Patient drinks alcohol socially (1-2 drinks per week).She never used tobacco.Patient was allergic to diphenhydramine hydrochloride (benadryl), codeine, minocycline, morphine, penicillins, sulfa (sulfonamides), synvisc, tetracyclines and naproxen (vimovo).Prior treatments included anti-inflammatory (aleve twice a day helps somewhat), cane use (no), brace use (patellar sleeve brace unconfortable), physical therapy (did not help).Patient had received synvisc one injection before on 18-jan-2017 in left knee and cortisone in oct-2017.Family history included asthma in father, coronary artery disease and heart disease in father and grandmother and high cholesterol, hypertension, rheumatoid arthritis, rheumatic fever and kidney disease in mother.On 06-nov-2017, magnetic resonance imaging (mri) of left knee showed mild osteoarthritis, complex tears in the posterior horn and root of the medial meniscus, mcl and acl strain, large joint effusion, bone contusion in the medial femoral condyle and tibial plateau and large popliteal cyst.On the same day, mri of right knee showed complex tears in the posterior horn, body and root of the medial meniscus, mcl strain, moderate osteoarthritis and chondromalacia patella, large joint effusion and bone contusion in the medial femoral condyle, tibial plateau and proximal mid tibia.A microfracture could not be excluded.On 06-nov-2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 48 mg (lot number: 7rsl021; frequency and expiry date: not reported) in both knees for osteoarthritis.The patient tolerated the procedure well.Bilateral knees were aspirated 20 cc of clear yellow synovial fluid prior to synvisc-one injections.On the same day, patient experienced allergic reaction.On 08-nov-2017, patient was complaining of significant pain with difficulty walking, big swollen knee.She was afebrile.Physical examination of bilateral knees demonstrates antalgic gait and range of motion 10-90 degrees due to pain.Afebrile and 3+ joint effusions stable.2+ distal pulses, intact sensation and motor function, no calf swelling and no edema.Patient reported that the patient walks like a penquin and had never had anything like the experience she was having now.Patient mentioned how much pain she was in.On 09-nov-2017, x-ray of both knees was done that showed medial joint space narrowing with marginal osteophyte formation, periarticular sclerosis and cysts bilaterally.Right knee showed diffuse global tenderness, effusion, lateral joint line tenderness.There was medial joint line tenderness, peripatellar pain and peripatellar crepitation in both knees.The patient displayed antalgic gait on right and antalgic gait on left.Also there was maculopapular erythematous lesions to bilateral knees, posterior fuillness, negative posterior drawer.On 03-jan-2018, patient complained primarily some pain and persistent swelling in the right knee.Her left knee was doing much better.On the same day, patient's right knee shows moderate effusion.Patient had no erythema, warmth or signs of infection.Patient had some stiffness secondary to swelling.Mild diffuse joint line pain as well as patellofemoral irritability, no calf pain or swelling, negative homans1 sign, mildly antalgic gait.On 03-jan-2018, after discussion with the patient regarding treatment options, a mutual decision was made to proceed with an aspiration/injection of the right knee joint.The right knee was sterilely prepped, and 30 cc of blood tinged clear synovial fluid.Fluid sent for routine studies including gram stain, cell count, crystals, protein, glucose, anaerobic and aerobic, afb and fungal cultures.The knee was then injected with a mixture of 4cc 1% lidocaine, 4cc, 0.25% bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog) 80mg.The patient tolerated the procedure well; post injection instructions were given.No obvious signs of infection based on fluid aspirate.Patient was reassured that there was no acute need for surgical intervention.Patient was scheduled for follow-up in two to three weeks or sooner should swelling persist or worsen.The patient was also aware to look for signs of infection such as fever, redness, increasing pain, etc.On 03-jan-2018, it was reported the patient's lab results showed synovial fluid cell count abnormal and synovial fluid orange.Corrective treatment: aspiration, mixture of 4cc 1% lidocaine, 4cc 0.25% marcaine and kenalog 80mg for right knee moderate effusion; not reported for other events outcome: unknown for all events a pharmaceutical technical complaint was initiated with global ptc number: 51775 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: medically significant for device malfunction and intervention required for right knee moderate effusion additional information was received on 09-jan-2018 from the patient.Event of trouble walking was updated to trouble walking/can't walk and and having challenges beyond words/walks like a penquin.Event of pain was added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 10-may-2018 from a physician.The case was medically confirmed.The case was upgraded to serious.Patient's demographics were added.Medical history, past drug were added.Additional events of right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, device malfunction right and left knee peripatellar crepitation were added along with details.The event term has trouble walking/can't walk and and having challenges beyond words/walks like a penquin was updated to has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait and pain was updated to pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness.Dose, indication and lot number of synvisc one was added.Investigation summary was updated.Related case was added.Clinical course was updated and text was amended accordingly.Additional information was received on 07-aug-2018 from the physician.Events of synovial fluid cell count abnormal and synovial fluid orange were added.Event of allergic reaction was added.Clinical course updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction] likely partially imaged enchondroma in the central/posterior margin of the distal femoral diaphysis [enchondroma] right knee moderate effusion/left knee effusion [effusion (r) knee] allergic reaction [allergic reaction] ([rash], [knee swelling]) pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness/tender to palpation medial joint line [arthralgia] ([pain aggravated]) patellofemoral irritability [patellofemoral pain syndrome] right and left knee peripatellar crepitation/significant retropatellar crepitation/clicking sensation [joint noise] synovial fluid orange [synovial fluid color] synovial fluid cell count abnormal [synovial fluid cell count] accident/auto accident [motor vehicle accident] just an irritation/fullness [discomfort in joints] joint locking [joint lock] weakness/decreased strength [weakness] gives out [joint instability] varus alignment right knee [knee deformity] some numbness [numbness] easy bruising [increased tendency to bruise] mri of right knee showed minor soft tissue damage [soft tissue injury nos] decreased rom [joint range of motion decreased] altered patellar mobility [mobility decreased] lacking independence in hep [loss of personal independence in daily activities] minimal erythema around left wrist iv site [erythema] itching around neck and arm [itching] limping [limping] has trouble walking/can't walk and and having challenges beyond words/walks like a penquin/mildly antalgic gait [gait inability] lightheadednes [lightheadedness] chills [chills] some stiffness secondary to swelling/tightness in her knee [joint stiffness].Case narrative: based on additional information received on 10-may-2018 from a physician, the case was medically confirmed.Also the case initially considered as non-serious was upgraded to serious as medically significant event of device malfunction was added.This case is cross referred with the case (b)(4) (same patient).This unsolicited case from united states was received on 03-jan-2018 from patient.This case concerns a 55 years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and had right knee moderate effusion/left knee effusion (latency: 2 days), had accident/auto accident (latency: 1 year 1 month 27 days), synovial fluid cell count abnormal and synovial fluid orange (latency: 1 month 28 days), after unknown latency had trouble walking/can't walk and having challenges beyond words/walks like a penguin/mildly antalgic gait, pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness/tender to palpation medial joint line, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, right and left knee peripatellar crepitation/clicking sensation, allergic reaction, minimal erythema around left wrist iv site, chills, itching around neck and arm, lightheadedness, lacking independence in hep, altered patellar mobility, mri of right knee showed minor soft tissue damage, easy bruising, varus alignment right knee, gives out, limping, weakness/decreased strength, joint locking, just an irritation/fullness, likely partially imaged enchondroma in the central/posterior margin of the distal femoral diaphysis, some numbness.Also device malfunction was reported for this lot number.Medical history included lower extremity vein surgery, bilateral knee arthritis, increasing pain as well as pain at night (pain described as aching, exhausting, miserable, nagging, penetrating, sharp, shooting, tender, throbbing and tiring), worsens with walking/activity, improves with rest, worsens with climbing stairs, worsens with descending stairs, improves with medication (takes edge off but not completely - aleve) and worsens with sleeping, moderate effusion in both knees, baker's cyst in left knee, tricompartmental djd worse in the medial and patellofemoral compartments with degenerative medial meniscal tear in left knee, tricompartmental degenerative joint disease (djd) with edema in the medial tibial plateau, medial femoral condyle and tibial spine with significant patellofemoral degenerative changes and degenerative medial meniscal tear in right knee and diffuse anterior medial knee pain, l tibial plateau treated nonoperatively in 2006, arthroscopy of the right, left knee in 2010 (2014), night sweats, nausea, heartburn, swelling lower extremities, muscle weakness, stiffness and joint pain.The patient previously had fracture repair of the left knee.Other previous surgeries include meniscus surgery in (b)(6) 2010 and (b)(6) 2015, hysterectomy in 2004.Patient had continued baker's cyst in right knee, pain, morning stiffness, pain with standing/sitting long periods, pain with walking long periods, recurrent swelling, weakness, tenderness, stiffness and instability, injury.Patient drinks alcohol socially (1-2 drinks per week).She never used tobacco.Patient was allergic to diphenhydramine hydrochloride (benadryl), codeine, minocycline, morphine, penicillins, sulfa (sulfonamides), synvisc, tetracyclines and naproxen (vimovo).Prior treatments included anti-inflammatory (aleve twice a day helps somewhat), cane use (no), brace use (patellar sleeve brace unconfortable), physical therapy (did not help).Patient had received synvisc one injection before on (b)(6) 2017 in left knee and cortisone in (b)(6) 2017.Family history included asthma in father, coronary artery disease and heart disease in father and grandmother, ischemic heart disease ini father and high cholesterol, hypertension, rheumatoid arthritis, rheumatic fever, deep vein thrombosis and end-stage renal disease in mother.Concomitant medication included acetylsalicyclic acid (aspirin) for deep vein thrombosis prophylaxis.On (b)(6) 2017, magnetic resonance imaging (mri) of left knee showed mild osteoarthritis, complex tears in the posterior horn and root of the medial meniscus, mcl and acl strain, large joint effusion, bone contusion in the medial femoral condyle and tibial plateau and large popliteal cyst.On the same day, mri of right knee showed complex tears in the posterior horn, body and root of the medial meniscus, mcl strain, moderate osteoarthritis and chondromalacia patella, large joint effusion and bone contusion in the medial femoral condyle, tibial plateau and proximal mid tibia.A microfracture could not be excluded.On (b)(6) 2017, the patient received treatment with intra-articular hylan g-f 20, sodium hyaluronate injection, at a dose of 48 mg (lot number: 7rsl021; frequency and expiry date: not reported) in both knees for osteoarthritis.The patient tolerated the procedure well.Bilateral knees were aspirated 20 cc of clear yellow synovial fluid prior to synvisc-one injections.On the same day, patient experienced allergic reaction.On (b)(6) 2017, patient was complaining of significant pain with difficulty walking, big swollen knee.She was afebrile.Physical examination of bilateral knees demonstrates antalgic gait and range of motion 10-90 degrees due to pain.Afebrile and 3+ joint effusions stable.2+ distal pulses, intact sensation and motor function, no calf swelling and no edema.Patient reported that the patient walks like a penquin and had never had anything like the experience she was having now.Patient mentioned how much pain she was in.On 09-nov-2017, x-ray of both knees was done that showed medial joint space narrowing with marginal osteophyte formation, periarticular sclerosis and cysts bilaterally.Right knee showed diffuse global tenderness, effusion, lateral joint line tenderness.There was medial joint line tenderness, peripatellar pain and peripatellar crepitation in both knees.The patient displayed antalgic gait on right and antalgic gait on left.Also there was maculopapular erythematous lesions to bilateral knees, posterior fuillness, negative posterior drawer.On (b)(6) 2017, it was reported patient had gradual pain in both her knees, pain was moderate with rating of 7/10, with associated symptoms swelling, weakness, locking/catching, pain and stiffness.It was reported that problem was getting worse by standing, walking, lifting, bending, stairs, squatting, kneeling, sitting and it was difficult to find comfortable position for sleep.The symptoms were made better by rest, elevation, ice.Patient was limping and gives out.There was mild effusion in right knee, patient was reported to be a candidate for total knee arthroplasty for right knee and patient had several conservative treatments including nsaids for at least 6 months.Patient was reported to be using knee brace, cane, cpm with soft goods and water circulating pad with pump.On an unknown date, patient had nausea and easy bruising.On (b)(6) 2018, patient complained primarily some pain and persistent swelling in the right knee.Her left knee was doing much better.On the same day, patient's right knee shows moderate effusion.Patient had no erythema, warmth or signs of infection.Patient had some stiffness secondary to swelling.Mild diffuse joint line pain as well as patellofemoral irritability, no calf pain or swelling, negative homans1 sign, mildly antalgic gait.It was reported that patient was allergic to hylan g-f 20, sodium hyaluronate and had rash and swelling due to it.On (b)(6) 2018, after discussion with the patient regarding treatment options, a mutual decision was made to proceed with an aspiration/injection of the right knee joint.The right knee was sterilely prepped, and 30 cc of blood tinged clear synovial fluid.Fluid sent for routine studies including gram stain, cell count, crystals, protein, glucose, anaerobic and aerobic, afb and fungal cultures.The knee was then injected with a mixture of 4cc 1% lidocaine, 4cc, 0.25% bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog) 80mg.The patient tolerated the procedure well; post injection instructions were given.No obvious signs of infection based on fluid aspirate.Patient was reassured that there was no acute need for surgical intervention.Patient was scheduled for follow-up in two to three weeks or sooner should swelling persist or worsen.The patient was also aware to look for signs of infection such as fever, redness, increasing pain, etc.On (b)(6) 2018, it was reported the patient's lab results showed synovial fluid cell count abnormal and synovial fluid orange.On 29-mnar-2018, patient reported to have significant retropatller crepitation and varus alignment right knee.Patient had failed conservative treatment.On (b)(6) 2018, patient had total knee arthroplasty, uncemented.Patient was having severe pain currently.She described it as 10 out of 10.She was having some nausea but no vomiting.She admitted to some lightheadedness.Physical therapy has not gotten her up yet, was treated with steroids.She also currently complained of some itching around her neck and her arm, chills and there is minimal erythema around her left wrist iv site.On(b)(6) 0218, patient showed moderate improvement, pain was moderate (5/10), 50% better, quality of pain was intermittent throbbing and aching.Right knee surgical incision was benign with mild swelling but no redness, drainage or erythema.On 07-jun-2018, patient had was getting clicking sensation when she reproduced biking motion and there was just irritation, had fullness and tightness in the knee.On (b)(6) 2018, patient reported to be walking and not using any cane and feeling good and incision form arthroplasty is benign with mild swelling but no redness.On (b)(6) 2019, patient had auto accident.On (b)(6) 2108, patient still had still has some numbness and tight feeling.On (b)(6) 2019, patient reported the knee was hurting, but improving and wanted to make sure nothing was hurt in the accident, was rear ended and had direct trauma to the sore knees.The right knee wound was healing and there was no drainage or surrounding erythema, range of motion was 0-130, good stability of the knees.Left knee had mild effusion, was tender to palpation medial joint line, gait was antalgic, favoring affected side.Total right knee arthroplasty was in excellent position and alignment with good cement mantle.The patella was tracking midline.On (b)(6) 2019, magnetic resonance imaging showed, likely partially imaged enchondroma in the central/posterior margin of the distal femoral diaphysis.On (b)(6) 2019, the magnetic resonance imaging showed soft tissue damage in right knee.Patient had decreased range of motion, strength, moderate swelling, altered patellar mobility and lacking independence in hep.Corrective treatment: aspiration, mixture of 4cc 1% lidocaine, 4cc 0.25% marcaine and kenalog 80mg for /left knee effusion; steroid for allergic reaction, total right knee arthroplasty, knee brace, walker, cpm, water circulating pad, ice, rest, elevation for pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness/tender to palpation medial joint line; cetirizine hydrochloride (zyrtec) for nausea, nsaids for joint locking, gives out, limping; altered patellar mobility, decreased rom; not reported for other events outcome: unknown for all events.A pharmaceutical technical complaint was initiated with global ptc number: 51775 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: medically significant, intervention required, disability for device malfunction and intervention required for right knee moderate effusion/left knee effusion; allergic reaction, intervention required for pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness/tender to palpation medial joint line, medically significant for likely partially imaged enchondroma in the central/posterior margin of the distal femoral diaphysis.Additional information was received on 09-jan-2018 from the patient.Event of trouble walking was updated to trouble walking/can't walk and having challenges beyond words/walks like a penguin.Event of pain was added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 10-may-2018 from a physician.The case was medically confirmed.The case was upgraded to serious.Patient's demographics were added.Medical history, past drug were added.Additional events of right knee moderate effusion, some stiffness secondary to swelling, patellofemoral irritability, right knee diffuse global tenderness/right and left knee medial joint line tenderness, knee swelling, device malfunction right and left knee peripatellar crepitation were added along with details.The event term has trouble walking/can't walk and and having challenges beyond words/walks like a penquin was updated to has trouble walking/can't walk and having challenges beyond words/walks like a penquin/mildly antalgic gait and pain was updated to pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness.Dose, indication and lot number of synvisc one was added.Investigation summary was updated.Related case was added.Clinical course was updated and text was amended accordingly.Additional information was received on 07-aug-2018 from the physician.Events of synovial fluid cell count abnormal and synovial fluid orange were added.Event of allergic reaction was added.Clinical course updated.Text amended accordingly.Additional information was received on 18-mar-2019 from lawyer.Medical history updated.Concomitant medications added.Events of some numbness, minimal erythema around left wrist iv site, chills, itching around neck and arm, lightheadedness, lacking independence in hep, altered patellar mobility, altered patellar mobility, mri of right knee showed minor soft tissue damage, easy bruising, varus alignment right knee, gives out, limping, weakness/decreased strength, joint locking, just an irritation/fullness, accident/auto accident, likely partially imaged enchondroma in the central/posterior margin of the distal femoral diaphysis added with details.Verbatim of event pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness was updated to pain/right and left knee peripatellar pain/mild diffuse joint line pain/right knee diffuse global tenderness/right and left knee medial joint line tenderness/tender to palpation medial joint line and its corrective treatment also updated.Verbatim of event right and left knee peripatellar crepitation updated to right and left knee peripatellar crepitation/clicking sensation.Seriousness criteria updated.Clinical course updated.Text amended accordingly.
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