| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problems
Bacterial Infection (1735); Weakness (2145); 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]; left septic knee arthritis [septic arthritis] ([swelling of l knee], [knee pain], [chills]; [fever], [effusion (l) knee]); decreased range of motion [joint range of motion decreased] ; not able to sleep [difficulty sleeping] ; back problems [back disorder nos]; difficulty with walking [walking difficulty] ; weakness [weakness].Initial information received on 08-oct-2018 from united states regarding an unsolicited legal valid serious case received from a lawyer.This case involves a (b)(6) years old female patient who experienced left septic knee arthritis, decreased range of motion, not able to sleep, back problems, difficulty with walking and weakness, device malfunction (latency- unknown), while she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included spinal fusion surgery, cholecystectomy and cardiac ablation.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing back pain and inguinal hernia repair in 2017.Patient was a non-smoker and ber had alcohol.Concomitant medications included cefazolin; atorvastatin calcium (atorvastin); cholecalciferol ; enoxaparin sodium (lovenox); mometasone furoate (flonase [mometasone furoate]); levothyroxine; loratadine; and pantoprazole.On (b)(6) 2017, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate) ,injection, dosage unknown via intra-articular route (lot - 7rsl021) for osteoarthritis and initiated treatment with steroid injection on an unknown date in (b)(6)2018.Because of the worsening problems with knee pain, she went to see her orthopedic surgeon who did a steroid injection the next day, the patient went to her aerobics class, but, when she came back, she had noted increasing swelling and pain.Due to the swelling and effusion, she began having some weakness and difficulty with walking.The patient noted increasing swelling when she was exercising.Kept ice on it for 9 hours.However, right after 12 a.M., the patient began having problem with intractable pain, not able to sleep and was rushed to emergency room.She presented to emergency and treatment had the knee was aspirated that showed an elevated white count but no organism on gram stain.The patient was transferred to another hospital.The patient had an ongoing problem with swelling with decreased range of motion.At the hospital, the patient got an x-ray done that showed prominent knee joint effusion, and mild degenerative.Changes.The patient had left knee effusion and possible left septic knee arthritis.The left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy were performed.The patient was taken to the recovery room in stable condition.A product technical complaint was initiated with date: 12-oct-2018, 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.Final diagnosis was weakness, difficulty with walking, back problems, not able to sleep, decreased range of motion and left septic knee arthritis.Relevant laboratory test results included: arthroscopy - on (b)(6) 2017: [i and d procedure]; aspiration joint - on (b)(6) 2017: [16,470 white cells]; culture - on (b)(6) 2017: negative unk; gram stain - on (b)(6) 2017: negative unk; x-ray - on (b)(6) 2017: [prominent knee joint]; effusion, and mild degenerative changes].Seriousness criteria- intervention required and medically significant for left knee left septic knee arthritis.Corrective treatment- left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy, iv antibiotics for left septic knee arthritis.Outcome- unknown for all events.Additional information received on 12-oct-2018.Global ptc number was added.Ptc results were added.Text amended accordingly.Follow up information received on 17-oct-2018 from lawyer.No new information received.
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Event Description
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Device malfunction [device malfunction] left septic knee arthritis [septic arthritis] ([swelling of l knee], [knee pain], [chills], [fever], [effusion (l) knee], [synovitis], [joint inflammation], [stiff knees]) decreased range of motion [joint range of motion decreased] not able to sleep [poor quality sleep] back problems/flare up of lower back pain [back pain aggravated] difficulty with walking/limp with ambulation [walking difficulty] weakness [weakness] clarity fluid cloudy [synovial fluid analysis abnormal] red blood cell fluid many [synovial fluid red blood cells positive] white blood cell fluid /monocyte fluid [synovial fluid white blood cells positive] case narrative: initial information received on 08-oct-2018 from united states regarding an unsolicited legal valid serious case received from a lawyer.This case involves a 74 years old female patient (171 cm) who experienced clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid (latency: 3 days) device malfunction, left septic knee arthritis, decreased range of motion, not able to sleep, back problems/flare up of lower back pain, difficulty with walking/limp with ambulation and weakness.(latency: unknown), while she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included status post lumbar fusion, spinal stenosis, cholecystectomy, av node ablation, inguinal hernia repair in (b)(6) 2017, pure hypercholestrolemia/hyperlipedemia (b)(6) 2007 postablative ovarian failure (b)(6) 2007depressive disorder (b)(6) 2007 allergic rhinitis (b)(6) 2007 postablative hypothyroidism (b)(6) 2007 sciatica, thyroidectomy, vaginal hysterectomy (1990), nasal surgery repair function (b)(6) 2013 palpitations, occassional alcohol user, spinal fusion (b)(6) 2013, atrial fibrillation, pyrogenic arthritis of left knee joint and hypotension/low blood pressure.Patient also had a history of having emotional problems, very dysfunctional, reclusive, anhedonic and had a hard time concentrating the patient's family history included lymphoma (cause of death), throat cancer with father, hypertension, colon cancer with mother (caused death), knee problems with brother, stroke, prostate cancer and reflux (gerd).Patient had left hip pain with severity: 5/10; which is aggravated by flexion and rolling onto left side when in bed and had associated symptoms: nocturnal awakening, weakness and feeling of giving away.Patient had bilateral knee pain with severity: 4/10 and associated symptom: crepitus and stiffness.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic back pain and was a non-smoker.Concomitant medications included cefazolin; atorvastatin calcium (atorvastin); vitamin d3; enoxaparin sodium (lovenox); mometasone furoate (flonase); pantoprazole; levothyroxine sodium (synthyroid); aspirin; loratadine (allerclear); macrogol 3350 (miralax); and omeprazole.On (b)(6) 2017, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate), injection, dosage unknown via intra-articular route (lot - 7rsl021) for osteoarthritis in both knees and initiated treatment with steroid injection on an unknown date in nov-2018.On the same day, patient had dexamethasone trochanteric bursa injection in left hip at the dose of 4 mg (1 ml).Because of the worsening problems with knee pain, she went to see her orthopedic surgeon who did a steroid injection.The next day, the patient went to her aerobics class, but, when she came back, she had noted increasing swelling and pain.Due to the swelling and effusion, she began having some weakness and difficulty with walking.The patient noted increasing swelling when she was exercising.Kept ice on it for 9 hours.However, right after 12 a.M., the patient began having problem with intractable pain, not able to sleep and soon afterwards she developed excruciating pain that resulted in rushing to emergency room.She presented to emergency and treatment had the knee was aspirated that showed an elevated white count but no organism on gram stain.The patient was transferred to another hospital.The patient had an ongoing problem with swelling with decreased range of motion.At the hospital, the patient got an x-ray done that showed showed prominent knee joint effusion, and mild degenerative changes.The patient had left knee effusion and possible left septic knee arthritis.With that, she had to have her knee operated on.The left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy were performed on (b)(6) 2017 and later patient was discharged on the same day.On (b)(6) 2017 at 16:30, the patient left knee effusion sample was collected.The investigation revelead thar synovial fluid: clarity: cloudy, red blood cell: many, white blood cell:11480 wbc/ul and monocyte:11.The patient was taken to the recovery room in stable condition.Since then she has decompensated and states she is an emotional wreck.Her phq9 score was 15.She wondered if some of this was related to her thyroid because apparently the formulation of her thyroid medication has changed at the base.The dose has not changed, just the formulation.She was very agitated.About 15 minutes of the appointment was spent in discussing her depression.She was started on escitalopram, but after ten days she does not think it is helping at all.Her anxiety was bad and she was tremulous.Later patient had very little pain in her knee at this time.She was doing well and ready to resume her pool therapy and other exercises starting.A product technical complaint was initiated with date: (b)(6) 2018, 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.Final diagnosis was device malfunction, left septic knee arthritis, decreased range of motion, not able to sleep, back problems/flare up of lower back pain, difficulty with walking/limp with ambulation and weakness.Relevant laboratory test results included: arthroscopy - on (b)(6) 2017: [i and d procedure], aspiration joint - on (b)(6) 2017: [16,470 white cells]; culture - on 11-nov-2017: negative unk; gram stain - on (b)(6) 2017: negative unk; x-ray - on (b)(6) 2017: [prominent knee joint] effusion, and mild degenerative changes.] haematocrit (34 - 47 %) - on (b)(6) 2017 32.7 % haemoglobin (11.0 - 12.5 g/dl) - on (b)(6) 2017 10.9 g/dl, red blood cell count (3.6 - 5.2 unk) - on 13-nov-2017: 3.33 unk [units: m/ul].Seriousness criteria- intervention required and medically significant for left knee left septic knee arthritis.Corrective treatment- left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy, iv antibiotics-vancomycin for left septic knee arthritis.Outcome- unknown for of clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid; not recovered/not resolved for back problems/flare up of lower back pain, difficulty with walking/limp with ambulation, decreased range of motion and weakness; unknown for all other events.Additional information received on 12-oct-2018.Global ptc number was added.Ptc results were added.Text amended accordingly.Follow up information received on 17-oct-2018 from lawyer.No new information received.Additional information received on 29-oct-2018 from lawyer.Events of clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid were added.Symptom of boggy synovitis, acute inflammation of the left knee joint and stiffness in the left knee was added.Medical history, family history and concomitant-medications were added.Verbatim of back problems/flare up of lower back pain and difficulty with walking/limp with ambulation was updated.Outcome of back problems/flare up of lower back pain, difficulty with walking/limp with ambulation, decreased range of motion, weakness.Clinical course was updated and text amended accordingly.Follow up information received on 29-oct-2018 from lawyer.No new information was received.Additional information was received on 29-oct-2018 from lawyer.Medical history updated.Clinical course updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction] left septic knee arthritis [septic arthritis] ([swelling of l knee], [knee pain], [chills], [fever], [effusion (l) knee], [synovitis], [joint inflammation], [stiff knees]) decreased range of motion [joint range of motion decreased] not able to sleep [poor quality sleep] back problems/flare up of lower back pain [back pain aggravated] difficulty with walking/limp with ambulation [walking difficulty] weakness [weakness] clarity fluid cloudy [synovial fluid analysis abnormal] red blood cell fluid many [synovial fluid red blood cells positive] white blood cell fluid /monocyte fluid [synovial fluid white blood cells positive] case narrative: initial information received on 08-oct-2018 from united states regarding an unsolicited legal valid serious case received from a lawyer.This case involves a 74 years old female patient (171 cm) who experienced clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid (latency: 3 days) device malfunction, left septic knee arthritis, decreased range of motion, not able to sleep, back problems/flare up of lower back pain, difficulty with walking/limp with ambulation and weakness.(latency: unknown), while she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included status post lumbar fusion, spinal stenosis, cholecystectomy, av node ablation, inguinal hernia repair in(b)(6) 2017, pure hypercholestrolemia/ hyperlipedemia ((b)(6) 2007), postablative ovarian failure (b)(6) 2007), depressive disorder ((b)(6) 2007), allergic rhinitis ((b)(6) 2007), postablative hypothyroidism (b)(6) 2007), sciatica, thyroidectomy, vaginal hysterectomy (1990), nasal surgery repair function (b)(6) 2013), palpitations, occassional alcohol user, spinal fusion (b)(6) 2013), atrial fibrillation, pyrogenic arthritis of left knee joint and hypotension/low blood pressure.Patient also had a history of having emotional problems, very dysfunctional, reclusive, anhedonic and had a hard time concentrating the patient's family history included lymphoma (cause of death), throat cancer with father, hypertension, colon cancer with mother (caused death), knee problems with brother, stroke, prostate cancer and reflux (gerd).The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic back pain and was a non-smoker.Concomitant medications included cefazolin ; atorvastatin calcium (atorvastin); vitamin d3; enoxaparin sodium (lovenox); mometasone furoate (flonase); pantoprazole; levothyroxine sodium (synthyroid); aspirin; loratadine (allerclear); macrogol 3350 (miralax); and omeprazole.On (b)(6) 2017, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate) ,injection, dosage unknown via intra-articular route (lot - 7rsl021) for osteoarthritis in both knees and initiated treatment with steroid injection on an unknown date in (b)(6) 2018.Because of the worsening problems with knee pain, she went to see her orthopedic surgeon who did a steroid injection the next day, the patient went to her aerobics class, but, when she came back, she had noted increasing swelling and pain.Due to the swelling and effusion, she began having some weakness and difficulty with walking.The patient noted increasing swelling when she was exercising.Kept ice on it for 9 hours.However, right after 12 a.M., the patient began having problem with intractable pain, not able to sleep and soon afterwards she developed excruciating pain that resulted in rushing to emergency room.She presented to emergency and treatment had the knee was aspirated that showed an elevated white count but no organism on gram stain.The patient was transferred to another hospital.The patient had an ongoing problem with swelling with decreased range of motion.At the hospital, the patient got an x-ray done that showed showed prominent knee joint effusion, and mild degenerative changes.The patient had left knee effusion and possible left septic knee arthritis.With that, she had to have her knee operated on.The left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplastyr and synovectomy were performed on (b)(6) 2017 and later patient was discharged on the same day.On (b)(6) 2017 at 16:30, the patient left knee effusion sample was collected.The investigation revelead thar synovial fluid: clarity: cloudy, red blood cell: many, white blood cell:11480 wbc/ul and monocyte:11.The patient was taken to the recovery room in stable condition.Since then she has decompensated and states she is an emotional wreck.Her phq9 score was 15.She wondered if some of this was related to her thyroid because apparently the formulation of her thyroid medication has changed at the base.The dose has not changed, just the formulation.She was very agitated.About 15 minutes of the appointment was spent in discussing her depression.She was started on escitalopram, but after ten days she does not think it is helping at all.Her anxiety was bad and she was tremulous.Later patient had very little pain in her knee at this time.She was doing well and ready to resume her pool therapy and other exercises starting.A product technical complaint was initiated with date: (b)(6) 2018, with global ptc number: 55880 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 (b)(6) 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.Final diagnosis was device malfunction, left septic knee arthritis, decreased range of motion, not able to sleep, back problems/flare up of lower back pain, difficulty with walking/limp with ambulation and weakness.Relevant laboratory test results included: arthroscopy - on (b)(6) 2017: [i and d procedure], aspiration joint - on (b)(6) 2017: [16,470 white cells]; culture - on (b)(6) 2017: negative unk; gram stain - on (b)(6) 2017: negative unk; x-ray - on (b)(6) 2017: [prominent knee joint] effusion, and mild degenerative changes.] haematocrit (34 - 47 %) - on (b)(6) 2017: 32.7 % haemoglobin (11.0 - 12.5 g/dl) - on (b)(6) 2017: 10.9 g/dl, red blood cell count (3.6 - 5.2 unk) - on (b)(6) 2017: 3.33 unk [units: m/ul].Seriousness criteria- intervention required and medically significant for left knee left septic knee arthritis.Corrective treatment- left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy, iv antibiotics-vancomycin for left septic knee arthritis.Outcome- unknown for of clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid; not recovered/not resolved for back problems/flare up of lower back pain, difficulty with walking/limp with ambulation, decreased range of motion and weakness; unknown for all other events.Additional information received on 12-oct-2018.Global ptc number was added.Ptc results were added.Text amended accordingly.Follow up information received on 17-oct-2018 from lawyer.No new information received.Additional information received on 29-oct-2018 from lawyer.Events of clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid were added.Symptom of boggy synovitis, acute inflammation of the left knee joint and stiffness in the left knee was added.Medical history, family history and concomitant-medications were added.Verbatim of back problems/flare up of lower back pain and difficulty with walking/limp with ambulation was updated.Outcome of back problems/flare up of lower back pain, difficulty with walking/limp with ambulation, decreased range of motion, weakness.Clinical course was updated and text amended accordingly.Follow up information received on 29-oct-2018 from lawyer.No new information was received.
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Event Description
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Device malfunction [device malfunction] left septic knee arthritis [septic arthritis] ([swelling of l knee], [knee pain], [chills], [fever], [effusion (l) knee], [synovitis], [stiff knees], [joint inflammation]) decreased range of motion [joint range of motion decreased] not able to sleep [poor quality sleep] back problems/flare up of lower back pain [back pain aggravated] difficulty with walking/limp with ambulation [walking difficulty] weakness [weakness] clarity fluid cloudy [synovial fluid analysis abnormal] red blood cell fluid many [synovial fluid red blood cells positive] white blood cell fluid /monocyte fluid [synovial fluid white blood cells positive].Case narrative: initial information received on 08-oct-2018 from united states regarding an unsolicited legal valid serious case received from a lawyer.This case involves a 74 years old female patient (171 cm) who experienced clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid (latency: 3 days) device malfunction, left septic knee arthritis, decreased range of motion, not able to sleep, back problems/flare up of lower back pain, difficulty with walking/limp with ambulation and weakness.(latency: unknown), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included status post lumbar fusion, spinal stenosis, cholecystectomy, av node ablation, inguinal hernia repair in (b)(6) 2017, pure hypercholestrolemia/hyperlipedemia ((b)(6) 2007), postablative ovarian failure (b)(6) 2007), depressive disorder ((b)(6) 2007), allergic rhinitis (b)(6) 2007), postablative hypothyroidism ((b)(6) 2007), sciatica, palpitations, occassional alcohol user, spinal fusion (jun-2013), atrial fibrillation, pyrogenic arthritis of left knee joint and hypotension/low blood pressure.Surgical history of thyroidectomy, vaginal hysterectomy (1990), nasal surgery repair function ((b)(6) 2013), reduction of l4-5 spondy, l4-5 lamin, foramen, facetec, discectomy, catheter ablation, spinal fusion, gallbladder and broken nose surgery.Patient also had a history of having emotional problems, very dysfunctional, reclusive, anhedonic and had a hard time concentrating the patient's family history included lymphoma (cause of death), throat cancer with father, hypertension, colon cancer with mother (caused death), knee problems with brother, stroke, prostate cancer and reflux (gerd).Patient had left hip pain with severity: 5/10; which is aggravated by flexion and rolling onto left side when in bed and had associated symptoms: nocturnal awakening, weakness and feeling of giving away.Patient had bilateral knee pain with severity: 4/10 and associated symptom: crepitus and stiffness.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic back pain and was a non-smoker.Concomitant medications included cefazolin; atorvastatin calcium (atorvastin); vitamin d3; enoxaparin sodium (lovenox); mometasone furoate (flonase); pantoprazole; levothyroxine sodium (synthyroid); aspirin; loratadine (allerclear); macrogol 3350 (miralax); and omeprazole.On (b)(6) 2016, patient received synvisc one injections in both knees for the first time which helped for 2-3 months.On (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate injection at 6ml once via intra-articular route (lot - 7rsl021) for osteoarthritis in both knees and initiated treatment with steroid injection on an unknown date in (b)(6) 2017.The site was prepped using povidone-iodine and the hylan g-f 20, sodium hyaluronate was injected.The patient tolerated the procedure well.On the same day, patient had dexamethasone trochanteric bursa injection in left hip at the dose of 4 mg (1 ml).Because of the worsening problems with knee pain, she went to see her orthopedic surgeon who did a steroid injection.On (b)(6) 2017, the patient went to her aerobics class, but, when she came back, she had noted increasing swelling and pain.Due to the swelling and effusion, she began having some weakness and difficulty with walking.The patient noted increasing swelling when she was exercising.Kept ice on it for 9 hours.However, right after 12 a.M., the patient began having problem with intractable pain, not able to sleep and soon afterwards she developed excruciating pain that resulted in rushing to emergency room.She presented to emergency and treatment had the knee was aspirated that showed an elevated white count but no organism on gram stain.The patient was transferred to another hospital.The patient had an ongoing problem with swelling with decreased range of motion.At the hospital, the patient got an x-ray done that showed showed prominent knee joint effusion, and mild degenerative changes.The patient had left knee effusion and possible left septic knee arthritis after her injections and was hospitalized for 6 days.With that, she had to have her knee operated on.The left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy were performed on(b)(6) 2017.The patient was premedicated in preoperative area and was then brought to the operating room and placed in supine position and general anesthesia was induced.The left lower extremity was prepped, tourniquet was placed and 30 cc of serosanguineous fluid was aspirated, trocar placed and joint was decompressed.The arthroscope was placed and cloudy fluid with abundant synovitis was found in the suprapatellar pouch with grade three chondromalacia.Further, the lateral compartment was entered and grade two chondromalacia was noticed, loose debris was removed and synovectomy was performed using an arthroscopic shaver.The joint was then flushed with copious amounts of saline, stitches were placed, portals were reapproximated ad patient was sent to recovery room in stable condition, later patient was discharged on the same day.On (b)(6) 2017 at 16:30, the patient left knee effusion sample was collected.The investigation revealed that synovial fluid: clarity: cloudy, red blood cell: many, white blood cell:11480 wbc/ul and monocyte: 11.The patient was taken to the recovery room in stable condition.Since then she has decompensated and states she is an emotional wreck.Her phq9 score was 15.She wondered if some of this was related to her thyroid because apparently the formulation of her thyroid medication has changed at the base.The dose has not changed, just the formulation.She was very agitated.About 15 minutes of the appointment was spent in discussing her depression.She was started on escitalopram, but after ten days she does not think it is helping at all.Her anxiety was bad and she was tremulous.Later patient had very little pain in her knee at this time.She was doing well and ready to resume her pool therapy and other exercises starting.A product technical complaint was initiated with date: (b)(6) 2018, 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.Final diagnosis was device malfunction, left septic knee arthritis, decreased range of motion, not able to sleep, back problems/flare up of lower back pain, difficulty with walking/limp with ambulation and weakness.Relevant laboratory test results included: arthroscopy - on (b)(6) 2017: [i and d procedure], aspiration joint - on (b)(6) 2017: [16,470 white cells]; culture - on (b)(6) 2017: negative unk; gram stain - on (b)(6) 2017: negative unk; x-ray - on (b)(6) 2017: [prominent knee joint] effusion, and mild degenerative changes.] haematocrit (34 - 47 %) - on (b)(6) 2017: 32.7 % haemoglobin (11.0 - 12.5 g/dl) - on (b)(6) 2017: 10.9 g/dl, red blood cell count (3.6 - 5.2 unk) - on (b)(6) 2017: 3.33 unk [units: m/ul].Seriousness criteria- hospitalization, intervention required and medically significant for left knee left septic knee arthritis and device malfunction.Corrective treatment- left knee arthroscopic debridement with subtotal medial meniscectomy, chondroplasty and synovectomy, iv antibiotics-vancomycin for left septic knee arthritis.Outcome- unknown for of clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid; not recovered/not resolved for back problems/flare up of lower back pain, difficulty with walking/limp with ambulation, decreased range of motion and weakness; unknown for all other events.Additional information received on 12-oct-2018.Global ptc number was added.Ptc results were added.Text amended accordingly.Follow up information received on 17-oct-2018 from lawyer.No new information received.Additional information received on 29-oct-2018 from lawyer.Events of clarity fluid cloudy, red blood cell fluid many and white blood cell fluid /monocyte fluid were added.Symptom of boggy synovitis, acute inflammation of the left knee joint and stiffness in the left knee was added.Medical history, family history and concomitant-medications were added.Verbatim of back problems/flare up of lower back pain and difficulty with walking/limp with ambulation was updated.Outcome of back problems/flare up of lower back pain, difficulty with walking/limp with ambulation, decreased range of motion, weakness.Clinical course was updated and text amended accordingly.Follow up information received on 29-oct-2018 from lawyer.No new information was received.Additional information was received on 29-oct-2018 from lawyer.Medical history updated.Clinical course updated.Text amended accordingly.Additional information received on 28-feb-2019 from lawyer.Surgical history of reduction of l4-5 spondy, l4-5 lamin, foramen, facetec, discectomy, catheter ablation, spinal fusion, gallbladder and broken nose surgery added.Suspect product dosage details added.Details pertaining to surgery added.Clinical course updated.Text amended accordingly.
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