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Device malfunction [device malfunction].Extreme tiredness/ exhaustion [fatigue].Confusing [confusion].Difficult walking/can barely walk [walking difficulty].Loss of appetite [appetite lost].Sweating [hyperhidrosis].Weighed 128 pounds and now ((b)(6) 2018), she weights 110 pounds [weight decreased].Coming down with a cold or virus [nasopharyngitis].Left knee swelled twice it size [knee swelling].Extreme pain [arthralgia].Case narrative: initial information received on (b)(6) 2018 regarding an unsolicited valid non-serious case received from united states via patient's daughter, brother, sister-in-law and brother.This case involves a (b)(6) years old female patient who experienced extreme tiredness/ exhaustion, confusing, difficult walking/can barely walk, loss of appetite, extreme pain, left knee swelled twice it size, sweating,weighed 128 pounds and now ((b)(6) 2018), she weights 110 pounds and coming down with a cold or virus, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one); also, device malfunction was identified for the reported lot number.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient does had any prosthetic device e.G.Prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator, previous/concomitant treatment with immunosuppressants and allergy history to avian proteins, feathers, or egg products on (b)(6) 2017, the patient started taking intra-articular hylan g-f 20, sodium hyaluronate injection (first injection) 6 ml once (lot - 7rsl021) in the left knee for unknown indication.Patient did not engage in activities such as jogging or tennis soon after the injection.A couple of days later following the first dose intake of hylan g-f 20, sodium hyaluronate, their patient had exhaustion, confusing, difficult walking, extreme tiredness, loss of appetite, extreme pain and could barely walk.Patient was able to walk a mile a day.Patient weighed 128 pounds and as of (b)(6) 2018 she weighed 110 pounds.The left knee swelled twice it size and their was swelling right above the left knee.They said the orthopedic physician did not give any instruction on the care the left knee after the injection.Patient did experience sweating and her temperature for any fever.The daughter thought patient was coming down with a cold or virus.They did not report their patient's knee problem or her symptoms to the orthopedic physician.They did said 6 months later, the physician did recommend a steroid shot for the left knee.No blood and/or knee sample cultures were performed.Patient was not hospitalized.It was not reported if the patient received a corrective treatment.The patient outcome was reported as not recovered / not resolved for all a product technical complaint was initiated on (b)96) 2018 for synvisc-one.Batch number: 7rsl021 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 criterion: medically significant for device malfunction.Follow up information received on 03-jul-2018.Global ptc number added.
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Device malfunction [device malfunction].Encephalopathy [encephalopathy] difficult walking/can barely walk/ abnormal gait [abnormal gait].Alteration of consciousness [consciousness disturbed].Dependent on help for activities for daily living [activities of daily living impaired].Cerebral atrophy [cerebral atrophy].Early dementia [dementia] ([memory loss]).Osteonecrosis [osteonecrosis].Left knee swelled twice it size/ swelling/ knee enlargment [knee swelling].Extreme pain/ joint pain/tenderness to palpitation/ pain/ hip pain [joint pain] ([radiating pain]).Extreme tiredness/ exhaustion/ extreme fatigue [fatigue].Loss of appetite [appetite lost].Confusing [confusion].Sweating [hyperhidrosis].Weighed 128 pounds and now ((b)(6) 2018), she weights 110 pounds [weight decreased] coming down with a cold or virus [nasopharyngitis].Pain in worse when ambulating and climbing stairs [pain upon movement].Mild cognitive impairment [cognitive impairment].Mild anemia [anemia].Wear glasses [eyeglasses wearer].Lower limb pain [pain in extremity].Insomnia [insomnia].Minimal range of motion decreased [joint range of motion decreased].Bitten by tick [tick bite].Knee joint effusion [knee effusion].Stiffness [joint stiffness].Hip joint effusion [joint effusion].Case narrative: initial information received on 26-jun-2018 regarding an unsolicited valid serious legal case received from united states via patient's daughter, brother, sister-in-law and brother.This case involves a 83 years old female patient (165 cm and 49.8 kg) who experienced encephalopathy, difficult walking/can barely walk/ abnormal gait, alteration of consciousness, dependent on help for activities for daily living, cerebral atrophy, early dementia, osteonecrosis, left knee swelled twice it size/ swelling/ knee enlargment, extreme pain/ joint pain/tenderness to palpitation/ pain/ hip pain, extreme tiredness/ exhaustion/ extreme fatigue, loss of appetite, confusing, sweating, weighed 128 pounds and now ((b)(6) 2018), she weighs 110 pounds, coming down with a cold or virus, pain in worse when ambulating and climbing stairs, mild cognitive impairment, mild anemia, wear glasses, lower limb pain, insomnia, minimal range of motion decreased, bitten by tick, knee joint effusion, stiffness and hip joint effusion, after she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Also, device malfunction was identified for the reported lot number.The patient's past medical history included hypothyroidism, meniscus repair, allergy from latex, uses alcohol occasionally, hypercholesterolcmia, thyroid disease, abdominal aortic ultrasound, bone density scan, carotid ultrasound, colonoscopy, cxr (chest x-ray: 2006,2008,2012), echo (1999, 2009), endoscopy (2001, 2016), venous doppler (2013), anorexia nervosa, glaucoma, gerd, hiatal hernia, crohn's disease, benign neoplasm of colon, hemorrhoids, esophagitis, gastritis, neck pain, diaphragmatic hernia, backache, urinary tract infectious disease, diverticular disease of colon, feces contents abnormal and allergy to tetanus.Her past treatment included left knee surgery, basal cells-mohs, tonsillectomy, knee arthroscopy-left, cataract removal-bilateral, had hospitalization for small bowel obstruction.Her family history included that her father had emphysema and copd.Her mother had congestive heart failure and diabetes.Her sibling had cancer.Her one son died due to aids.Her second son had tinitis and lung cancer.Her vaccination(s) history was not provided.Patient does had any prosthetic device e.G.Prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator, previous/concomitant treatment with immunosuppressants and allergy history to avian proteins, feathers, or egg products her concomitant medication included levothyroxine sodium (synthroid), naproxen sodium (aleve); garlic, lactobacillus acidophilus (acidophilus probiotic), acetylsalicylic acid (bufferin), mecobalamin (b12), cod liver oil (cod liver oil), e400, linum usitatissimum seed oil (flax seed oil), lorazepam (ativan); folic acid, diclofenac sodium (pennsaid), ubidecarenone (coq10), diclofenac sodium (voltaren), famotidine, acetylcarnitine hydrochloride (acetyl l-carnitine), lactobacillus rhamnosus, fish oil, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (centrum silver) prednisone, colecalciferol (d3); atorvastatin calcium (atorvastatin calcium); tramadol hcl (tramadol hcl), clopidogrel besylate (placard) and lidocaine (lidoderm).On (b)(6) 2017, the patient started taking intra-articular hylan g-f 20, sodium hyaluronate injection (first injection) 6 ml once (lot - 7rsl021) in the left knee for unknown indication.Patient did not engage in activities such as jogging or tennis soon after the injection.A couple of days later following the first dose intake of hylan g-f 20, sodium hyaluronate, their patient had exhaustion, confusing, difficult walking, extreme tiredness, loss of appetite, extreme pain and could barely walk.Patient was able to walk a mile a day.Patient weighed 128 pounds and as of 26-jun-2018 she weighed 110 pounds.The left knee swelled twice it size and their was swelling right above the left knee.They said the orthopedic physician did not give any instruction on the care the left knee after the injection.Patient did experience sweating and her temperature for any fever.The daughter thought patient was coming down with a cold or virus.They did not report their patient's knee problem or her symptoms to the orthopedic physician.They did said 6 months later, the physician did recommend a steroid shot for the left knee.No blood and/or knee sample cultures were performed.Patient was not hospitalized.On (b)(6) 2018, patient underwent lab analysis and it was observed that red blood cell was 4.00 (low), mchc was 15.3 % (high), glucose was 136 mmol/l (high), cholesterol was 231 mg/dl (high), hdl cholesterol was 102 mg/dl (high) and calculated hdl was 131.8 calc (high).On 1(b)(6) 2018, patient went for medical evaluation and it was reported that for past couple of months patient was getting more forgetful.She thought to have some age related memory loss but change was more drastic from past couple of months.It was also reported that patient was having extreme fatigue.Her daughter was also concerned that patient mite have been bitten by a tick even though she did not see any tick nor any rash but she had knee enlargement out of the blue that lasted few days and then improved.It was also reported that patient had mild anemia due to which she was extremely tired.On the same day, she underwent lab analysis and it was observed that red blood count of 3.78 m/mm3 (low), mcv was 95.6 fl (high) and mch was 31.7 pg (high).On (b)(6) 2018, she was observed with vca ab, igg positive and epstein barr nuclear antigen was positive.On (b)(6) 2018, it was also reported that her family noticed memory loss.It was also reported that she had mildly elevated serum copper at 1.56.On the evaluation, she was observed with extreme fatigue.She was wearing glasses and had insomnia.She was also having joint pain.On (b)(6) 2018, serum copper was 1.57 mcg/ml (high).On (b)(6) 2018, patient underwent lab analysis and it was observed that leukocyte esterase in urine was in traces and red blood cell in urine were 17 /hpf (high).During the evaluation of (b)(6) 2018, patient was diagnosed with mild cognitive impairment.She also abnormal gait mainly secondary to hip problems.On (b)(6) 2018, patient underwent lab analysis and it was observed that red blood cell count was 3.80 m/mm3 (low), mcv was 96.7 fl (high) and mch was 32.1 pg (high) and glucose was 112 mg/dl (high) and vitamin b12 was 1221 pg/ml (193-986).On the medical evaluation on (b)(6) 2018, patient complained that she severe pain in the right knee with the stairs, walking.She also stated that she severe oa of the left hip.Her left knee was not painful but it seemed swollen.On (b)(6) 2018, during lab analysis, she was observed with creatinine 0.58 mg/dl (low) and bun/ creatinine ratio was 28 calc (high), sedimentation ratio was 38 mm/h (high) and homocysteine was 11.5 umol/ l (high) and hs-crp was 16.9 mg/l (high).On (b)(6) 2018, it was observe during evaluation it was observed that it was worse with walking.She had been diagnosed with avascular necrosis of bilateral knees and had minimal range of motion.The pain from her hip radiated from her hip all the way down to her knee.On (b)(6) 2018, during lab evaluation, it was observed that carbon dioxide was 33 mmol/l (high), mcv was 37.9 (high) and mch was 33.3 pg (high).On (b)(6) 2018, during the mri of bilateral knees, she was observed with osteonecrosis.Knee joint effusion was also observed.It was also reported that she had synvisc injection to the left knee that increased her symptoms and was found to have contaminated/ infectious product.Approximate 4 months afterwards she had monovisc injections.On (b)(6) 2018, patient was pain and having difficulty in sleeping.On (b)(6) 2018, it was observed that glucose level was 121 mg/dl (high) and carbon dioxide was 30 (high).On the (b)(6) 2018, during the mri evaluation, it was observed that the patient had encephalopathy and alteration of consciousness.She was also observed with cerebral atrophy.She was also having early dementia.The event of encephalopathy was assessed as serious with the seriousness criteria of medically significant.The event of difficult walking/can barely walk/ abnormal gait was assessed as serious due to seriousness criteria of disability.The event of alteration of consciousness was assessed as serious with the seriousness criteria of medically significant.The event of dependent on help for activities for daily living was assessed as serious with the seriousness criteria of disability.The event of cerebral atrophy was assessed as serious with the seriousness criteria of medically significant.The event of early dementia was assessed as serious with the seriousness criteria of medically significant.The event of osteonecrosis was assessed as serious with the seriousness criteria of medically significant.The event of left knee swelled twice it size/ swelling/ knee enlargement was assessed as serious with the seriousness criteria of intervention required.The seriousness criteria of extreme pain/ joint pain/tenderness to palpitation/ pain/ hip pain was assessed as serious with the seriousness criteria of intervention required.Corrective treatment: lidocaine (lidoderm), meloxicam (mobic), methylprednisolone acetate (depo-medrol) and paracetamol (tylenol) for extreme pain/ joint pain/tenderness to palpitation/ pain/ hip pain; not reported for rest of the events.Outcome: unknown for encephalopathy, alteration of consciousness, dependent on help for activities for daily living, cerebral atrophy, early dementia, osteonecrosis, pain in worse when ambulating and climbing stairs, mild cognitive impairment, mild anemia, wear glasses, lower limb pain, insomnia, minimal range of motion decreased, bitten by tick, knee joint effusion, stiffness and hip joint effusion not recovered / not resolved for rest of the events.A product technical complaint was initiated on (b)(6) 2018 for synvisc-one.Batch number: 7rsl021 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 criterion: medically significant for device malfunction, encephalopathy, alteration of consciousness, cerebral atrophy, early dementia, osteonecrosis; disability for dependent on help for activities for daily living, difficult walking/can barely walk/ abnormal gait; intervention required for left knee swelled twice it size/ swelling/ knee enlargement, extreme pain/ joint pain/tenderness to palpitation/ pain/ hip pain.Follow up information received on 03-jul-2018.Global ptc number added.Additional information was received on 19-jun-2019 from the lawyer.Additional events of encephalopathy, alteration of consciousness, dependent on help for activities for daily living, cerebral atrophy, early dementia, osteonecrosis, pain in worse when ambulating and climbing stairs, mild cognitive impairment, mild anemia, wear glasses, lower limb pain, insomnia, minimal range of motion decreased, bitten by tick, knee joint effusion, stiffness and hip joint effusion were added.Verbatim for left knee swelled twice it size/ swelling was updated to left knee swelled twice it size/ swelling/ knee enlargement.Verbatim for extreme pain/ joint pain updated to extreme pain/ joint pain/tendeness to palpitation/ pain/ hip pain.Verbatim for extreme tiredness/ exhaustion was updated to extreme tiredness/ exhaustion/ extreme fatigue.Patient's concomitant medication added.Corrective treatments were added.Medical history was added.Clinical course updated and text amended accordingly.
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