| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Fatigue (1849); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Swelling (2091); Thrombosis (2100); Arthralgia (2355); Joint Disorder (2373); No Code Available (3191)
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Event Type
Injury
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Event Description
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This spontaneous case from united states was received on 11-jan-2018 from the patient this case concerns (b)(6) years old female patient who initiated treatment with synvisc one and after an unknown latency had a surgery.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose, indication: not provided; batch/ lot number: 7rsl021and expiry date: unknown) for osteoarthritis.On an unknown date after an unknown latency, patient developed a dvt due to surgery (onset and latency: unknown for both) that was necessary as the result of receiving the synvisc one injection.Corrective treatment: rivaroxaban (xarelto) for dvt; not reported for surgery and device malfunction.Outcome: unknown for dvt and surgery.Seriousness criteria: important medical event for all 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.Pharmacovigilance comment: sanofi company comment dated 17-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced deep vein thrombosis due to surgery.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration.However, patient experienced deep vein thrombosis as complication of surgery and hence, causal role of suspect product in occurrence of the event cannot be suspected.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction] surgery/knee arthroscopy [knee arthroscopy] dvt/dvt of left calf [dvt of calf] ([calf pain]) not walking well [walking difficulty] left total knee arthroplasty [arthroplasty of knee] left side feels weaker [weakness left or right side] knee joint infection [joint infection] creaking and popping in knee/feels as if the knee might pop/creaking in left knee/ more crepitus during standing exercises/clicking in the right leg during forward step ups compared to the left [joint crepitation] impaired joint mobility [mobility decreased] pain has been in her breast the last few days and feels like muscle tightness.[breast pain] aggravation of bone on bone placed on knee [knee deformity nos] feeling a lot of pressure [sensation of pressure] weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be [weakness of limbs] impaired muscle performance [muscle disorder nos] leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her [leg pain] ache during standing [difficulty in standing] fatigue [fatigue] back starts to hurt/lower back pain [low back pain] clean out both knees [knee operation] lower extremity swelling of bilateral lower extremities [swelling of limbs] osteoarthritis of both knees [osteoarthritis knees] monocytes increased [monocytes increased] eosinophils increased [eosinophil count increased] basophil increased [basophil count increased] sf nucleated cell count high, polymorphonuclears, mononuclears [synovial fluid white blood cells positive] knees were pretty stiff/stiffness [stiff knees] pain has drastically increased / new kind of knee pain [knee pain] ([condition aggravated]) knee effusion [knee effusion] joint range of motion decreased/difficulty with forward and lateral step ups with left leg [joint range of motion decreased] constipation [constipation] hypertension [hypertension] bun high [blood urea nitrogen increased] sciatic nerve pain [sciatic neuralgia] case narrative: this spontaneous legal case from united states was received on 11-jan-2018 from the nurse.This case concerns (b)(6) female patient who initiated treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and hydrocodone hydrochloride/paracetamol (hydrocodone/acetaminophen); on the same day had knees were pretty stiff/stiffness, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her; after 13 days had sf nucleated cell count high, polymorphonuclears, mononuclears; and after an unknown latency had a surgery/knee arthroscopy, not walking well, sciatic nerve pain, creaking and popping in knee, pain has drastically increased / new kind of knee pain, joint range of motion decreased, clean out both knees, pain has been in her breast the last few days and feels like muscle tightness, aggravation of bone on bone placed on knee, left side feels weaker, impaired joint mobility, feeling a lot of pressure, weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be, impaired muscle performance, ache during standing, fatigue and back starts to hurt/lower back pain.Also after few days, patient had dvt/dvt of left calf, lower extremity swelling of bilateral lower extremities, constipation, hypertension, knee effusion, osteoarthritis of both knees, monocytes increased, eosinophils increased, basophil increased, blood urea nitrogen (bun) high and had knee joint infection the patient had medical history of osteoarthritis, arthritis, chronic knee pain, foreign body in ear, hearing loss, bilateral, hiatal hernia, hyperlipidemia, osteoporosis, appendectomy, bladder repair, bilateral cataract surgery, hysterectomy, synovectomy, bilateral knee arthroscopy ((b)(6) 2017), tonsillectomy, left total knee arthroplasty, back pain, pollakiuria, cystocele repair, thirst, decreased appetite, temperature regulation disorder, arthralgia, infective arthritis of left knee, peptic ulcers, diabetes mellitus, peptic ulcer disease, septic arthritis, degenerative joint disease, abnormal blood pressure, mild bony hypertrophy, endplate sclerosis of tibial plateau, colon polyp, supralateral joint effusion, mild cardiomegaly, neutrophil percentage increased, wbc count increased, rdw increased, platelet count increased, left knee septic arthritis status post arthroscopy, influenza a positive, mild hematemesis, gerd, gastrointestinal prophylaxis and deep vein thrombosis prophylaxis.Concomitant medications included amlodipine, aspirin, calcium carbonate and vitamin d, lansoprazole, meloxicam, potassium gluconate, cetirizine hydrochloride (zyrtec) and senokot for constipation.Patient was allergic to erythromycin, penicillins and sulfa (sulfonamide antibiotics).Family history included arthritis and cerebrovascular accident in father, daughter and spouse.Patient never used alcohol and was a former tobacco user (quit in 1987) and is non-alcoholic.On (b)(6) 2017, patient received treatment with intra articular hylan g-f 20, sodium hyaluronate injection once (dose, indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown) for osteoarthritis bilateral knees which needs to be flushed out on (b)(6) 2017 due to a recall for possible sterile injection needles with synvisc.On the same day the patient reported having swelling and stiffness in knee.The patient was in with orders for pt following knee scope to clean out both knees; after the injection in knees the pain had drastically increased; as the synvisc received was a bad batch and the knees had to be cleaned out with in the scope.On an unknown date patient reported that he was not walking well and was had to use cane.On (b)(6) 2017, patient had synovial fluid analysis that revealed nucleated cells, polymorphonuclears, mononuclears.On an unknown date in (b)(6) 2017, patient was hospitalized.On (b)(6) 2017, patient had knee arthroscopy.On an unknown date after an unknown latency, patient developed a dvt due to surgery.It was reported that the patient was started on clindamycin from (b)(6) 2017 for total 7 days for concern knee joint infection (onset date and latency: unknown).On (b)(6) 2017, few days after the injection, patient was diagnosed with dvt of left calf and was started on xarelto.Patient denied any bleeding, bruising, blood in stool, melena, shortness of breath, dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea (pnd).Patient also had lower extremity swelling of bilateral lower extremities.On (b)(6) 2017, at 12:10, patients monocyte count was 8% (h) (normal range: 2-6%), eosinophil: 5% (h) (normal range: 2-4%), bun: 23 mg/dl (h) (normal range: 7-20) and basophil count: 2% (h) (normal: 0-1%).On the same day, patient had hypertension and osteoarthritis of both knees.On unknown dates, after unknown latency, the patient had complaint of left side pain near the breast and voiced the pain had been in her breast the last few days, felt like a muscle tightness, voiced a new kind of knee pain that she experienced the day before when walking but stated it went away and her joint range of motion was decreased.On (b)(6) 2018, patient visited the medical centre for follow up for dvt to left calf, weakness to bilateral legs and pain to bilateral knees.It was reported that the patient denied any problem with xarelto.Patient had followed up with physical therapy (pt) for the past week and wanted to get stronger legs.Patient denied any fever, chills, knee joint swelling or redness or pain, blood in stool, occasional bleeding of gums but no spontaneous epistaxis and no noticeable bruising of her body.Patient had an intermittent pain of her left calf after dvt.Patient denied any dysphagia, coughing and odynophagia.It was reported that the patient had long term use of anticoagulants.On (b)(6) 2018, bp (blood pressure) was taken after recumbent stepper was complete at 148/80 and again at the end of the day was at 148/76.Patient was advised to contact primary md or secondary md to address chest pain symptoms and continued to have most difficulty with sidelying abduction.Treatment emphasis was to focus on muscle function improvements.On an unknown date, after unknown latency, due to creaking and popping in knee, forward and lateral toe taps arc were added in replacement of steps ups.Toe taps emphasize balance and strength but avoid pressure on the knee joint keeping the knee safe.On (b)(6) 2018, the patient was happy to report her knees were finally feeling better.On (b)(6) 2018, the patient reported having over done it the day before going up and down the stairs so many times.The patient reported that she would like to work on her strength prior to her upcoming knee surgery.On (b)(6) 2018, patient completed 3 month course of provoked dvt.It was reported that the patient had not rescheduled her esophagogastroduodenoscopy (egd) for dilation.On (b)(6) 2018, patient had monocyte: 10% (h), eosinophil: 5% (h), bun: 23 mg/dl and basophil: 2% (h).On (b)(6) 2018, patient came for pre-operative exam for left knee replacement.It was reported that the patient could continue her blood pressure medicines preoperatively and was recommended for anticoagulation postoperatively due to her recent history of dvt.Also a d dimer should be obtained to see if the patient had a high chance of recurrence of dvt.The patient had a left total knee arthroplasty on (b)(6) 2018 and returned on (b)(6) 2018.It was reported that the patients swelling had been going on since her knee surgeries.On (b)(6) 2018, the patient was educated regarding their diagnosis, prognosis and related pathology.The patient exhibited excellent understanding and performance of the therapeutic activity/instructions outlined during this skilled rehabilitation session.Clinical findings were consistent with a musculoskeletal pattern of impaired joint mobility, motor function, muscle performance, and range of motion associated with joint arthroplasty.On unknown dates, after unknown latencies, the patient experienced left side feels weaker, impaired joint mobility, feeling a lot of pressure, sciatic nerve pain knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain.On an unknown date, patient started taking hydrocodone hydrochloride/paracetamol, 1 tablet by oral route every 4-6 hours as needed for pain.On an unknown date, after unknown latency, patient noted some constipation due to hydrocodone hydrochloride/paracetamol.Action taken: unknown for hydrocodone hydrochloride/paracetamol.Corrective treatment: rivaroxaban (xarelto) for dvt; clindamycin for knee joint infection, amlodipine for pain; not reported for rest of the events.Outcome: recovering for impaired joint mobility, pain has drastically increased / new kind of knee pain and joint range of motion decreased/difficulty with forward and lateral step ups with left leg; unknown for rest all events.Seriousness criteria: medically significant and hospitalization for surgery/knee arthroscopy and left total knee arthroplasty, medically significant for dvt/ dvt of left calf, left side feels weaker, knee joint infection and device malfunction.A pharmaceutical technical complaint (ptc) 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.Follow up was received on 30-jan-2018.No new information received.Additional information was received on 06-feb-2018.Global ptc number was added.Text amended accordingly.Additional information was received on 08-may-2018 from a physician.Additional events of creaking and popping in knee, pain has drastically increased / new kind of knee pain, joint range of motion decreased, clean out both knees, pain has been in her breast the last few days and feels like muscle tightness and aggravation of bone on bone placed on knee were added.Labs and medical history added.Clinical course was updated.Text amended accordingly.Additional information was received on 08-may-2018 from the medical doctor.Additional events of left side feels weaker, impaired joint mobility, feeling a lot of pressure, knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain were added.Suspect product batch number, expiration date and indications were added.Clinical course was updated and text was amended accordingly.Additional information was received on 14-may-2018 from the health care professional.Medical history, concomitant medications were added.Additional suspect product hydrocodone hydrochloride; paracetamol was added along with details.Additional events of lower extremity swelling of bilateral lower extremities, constipation, hypertension, knee effusion, osteoarthritis of both knees, monocytes increased, eosinophils increased, basophil increased, bun high, left total knee arthroplasty and had knee joint infection were added along with details.The event term dvt was updated to dvt/dvt of left calf and surgery was updated to surgery/ knee arthroscope.Laboratory test results were added.Clinical course was updated and text was amended accordingly.Additional information was received on 04-jun-2018.Patients medical history was added.Clinical course was updated and text was amended accordingly.Additional information was received on 01-jun-2018.Medical history and concomitant medications were added.Event of sf nucleated cell count high, polymorphonuclears, mononuclears, was not walking well and sciatic nerve pain 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] surgery/knee arthroscopy [knee arthroscopy] dvt/dvt of left calf [dvt of calf] ([calf pain]) not walking well [walking difficulty] left total knee arthroplasty [arthroplasty of knee] left side feels weaker [weakness left or right side] knee joint infection [joint infection] creaking and popping in knee/feels as if the knee might pop/creaking in left knee/ more crepitus during standing exercises/clicking in the right leg during forward step ups compared to the left [joint crepitation] impaired joint mobility [mobility decreased] pain has been in her breast the last few days and feels like muscle tightness.[breast pain] aggravation of bone on bone placed on knee [knee deformity nos] feeling a lot of pressure [sensation of pressure] weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be [weakness of limbs] impaired muscle performance [muscle disorder nos] leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her [leg pain] ache during standing [difficulty in standing] fatigue [fatigue] back starts to hurt/lower back pain [low back pain] clean out both knees [knee operation] lower extremity swelling of bilateral lower extremities [swelling of limbs] osteoarthritis of both knees [osteoarthritis knees] monocytes increased [monocytes increased] constipation [constipation] hypertension [hypertension] eosinophils increased [eosinophil count increased] bun high [blood urea nitrogen increased] sciatic nerve pain [sciatic neuralgia] basophil increased [basophil count increased] sf nucleated cell count high, polymorhonuclears, mononuclears [synovial fluid white blood cells positive] knees were pretty stiff/stiffness [stiff knees] pain has drastically increased / new kind of knee pain [knee pain] ([condition aggravated]) knee effusion [knee effusion] joint range of motion decreased/difficulty with forward and lateral step ups with left leg [joint range of motion decreased] case narrative: this spontaneous legal case from united states was received on 11-jan-2018 from the nurse.This case concerns 80 years old female patient who initiated treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and hydrocodone hydrochloride/paracetamol (hydrocodone/acetaminophen); on the same day had knees were pretty stiff/stiffness, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her; after 13 days had sf nucleated cell count high, polymorhonuclears, mononuclears; and after an unknown latency had a surgery/knee arthroscopy, not walking well, sciatic nerve pain, creaking and popping in knee, pain has drastically increased / new kind of knee pain, joint range of motion decreased, clean out both knees, pain has been in her breast the last few days and feels like muscle tightness, aggravation of bone on bone placed on knee, left side feels weaker, impaired joint mobility, feeling a lot of pressure, weakness on the left leg compared to the right leg/leg strength isnt where she would like it to be, impaired muscle performance, ache during standing, fatigue and back starts to hurt/lower back pain.Also after few days, patient had dvt/dvt of left calf, lower extremity swelling of bilateral lower extremities, constipation, hypertension, knee effusion, osteoarthritis of both knees, monocytes increased, eosinophils increased, basophil increased, blood urea nitrogen (bun) high and had knee joint infection the patient had medical history of osteoarthritis, arthritis, chronic knee pain, foreign body in ear, hearing loss, bilateral, hiatal hernia, hyperlipidemia, osteoporosis, appendectomy, bladder repair, bilateral cataract surgery, hysterectomy, synovectomy, bilateral knee arthroscopy (dec-2017), tonsillectomy, left total knee arthroplasty, back pain, pollakiuria, cystocele repair, thirst, decreased appetite, temperature regulation disorder, arthralgia, infective arthritis of left knee, peptic ulcers, diabetes mellitus, peptic ulcer disease, septic arthritis, degenerative joint disease, abnormal blood pressure, mild bony hypertrophy, endplate sclerosis of tibial plateau, colon polyp, supralateral joint effusion, mild cardiomegaly, neutrophil percentage increased, wbc count increased, rdw increased, platelet count increased, left knee septic arthritis status post arthroscopy, influenza a positive, mild hematemesis, gerd, gastrointestinal prophylaxis and deep vein thrombosis prophylaxis.Concomitant medications included amlodipine, aspirin, calcium carbonate and vitamin d, lansoprazole, meloxicam, potassium gluconate, cetirizine hydrochloride (zyrtec) and senokot for constipation.Patient was allergic to erythromycin, penicillins and sulfa (sulfonamide antibiotics).Family history included arthritis and cerebrovascular accident in father, daughter and spouse.Patient never used alcohol and was a former tobacco user (quit in 1987) and is non-alcoholic.On (b)(6) 2017 , patient received treatment with intra articular hylan g-f 20, sodium hyaluronate injection once (dose, indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown) for osteoarthritis bilateral knees which needs to be flushed out on 16-dec-2017 due to a recall for possible sterile injection needles with synvisc.On the same day the patient reported having swelling and stiffness in knee.The patient was in with orders for pt following knee scope to clean out both knees; after the injection in knees the pain had drastically increased; as the synvisc received was a bad batch and the knees had to be cleaned out with in the scope.On an unknown date patient reported that he was not walking well and was had to use cane.On (b)(6) 2017 patient had synovial fluid analysis that revealed nucleated cells, polymorhonuclears, mononuclears.On an unknown date in (b)(6) 2017 , patient was hospitalized.On (b)(6) 2017 patient had knee arthroscopy.On an unknown date after an unknown latency, patient developed a dvt due to surgery.It was reported that the patient was started on clindamycin from (b)(6) 2017 for total 7 days for concern knee joint infection (onset date and latency: unknown).On (b)(6) 2017 , few days after the injection, patient was diagnosed with dvt of left calf and was started on xarelto.Patient denied any bleeding, bruising, blood in stool, melena, shortness of breath, dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea (pnd).Patient also had lower extremity swelling of bilateral lower extremities.On (b)(6) 2017 at 12:10, patients monocyte count was 8% (h) (normal range: 2-6%), eosinophil: 5% (h) (normal range: 2-4%), bun: 23 mg/dl (h) (normal range: 7-20) and basophil count: 2% (h) (normal: 0-1%).On the same day, patient had hypertension and osteoarthritis of both knees.On unknown dates, after unknown latency, the patient had complaint of left side pain near the breast and voiced the pain had been in her breast the last few days, felt like a muscle tightness, voiced a new kind of knee pain that she experienced the day before when walking but stated it went away and her joint range of motion was decreased.On (b)(6) 2018, patient visited the medical centre for follow up for dvt to left calf, weakness to bilateral legs and pain to bilateral knees.It was reported that the patient denied any problem with xarelto.Patient had followed up with physical therapy (pt) for the past week and wanted to get stronger legs.Patient denied any fever, chills, knee joint swelling or redness or pain, blood in stool, occasional bleeding of gums but no spontaneous epistaxis and no noticeable bruising of her body.Patient had an intermittent pain of her left calf after dvt.Patient denied any dysphagia, coughing and odynophagia.It was reported that the patient had long term use of anticoagulants.On (b)(6) 2018, bp (blood pressure) was taken after recumbent stepper was complete at 148/80 and again at the end of the day was at 148/76.Patient was advised to contact primary md or secondary md to address chest pain symptoms and continued to have most difficulty with sidelying abduction.Treatment emphasis was to focus on muscle function improvements.On an unknown date, after unknown latency, due to creaking and popping in knee, forward and lateral toe taps arc were added in replacement of steps ups.Toe taps emphasize balance and strength but avoid pressure on the knee joint keeping the knee safe.On (b)(6) 2018 the patient was happy to report her knees were finally feeling better.On (b)(6) 2018 the patient reported having over done it the day before going up and down the stairs so many times.The patient reported that she would like to work on her strength prior to her upcoming knee surgery.On 16-mar-2018, patient completed 3 month course of provoked dvt.It was reported that the patient had not rescheduled her esophagogastroduodenoscopy (egd) for dilation.On 16-apr-2018, patient had monocyte: 10% (h), eosinophil: 5% (h), bun: 23 mg/dl and basophil: 2% (h).On (b)(6) 2018, patient came for pre-operative exam for left knee replacement.It was reported that the patient could continue her blood pressure medicines preoperatively and was recommended for anticoagulation postoperatively due to her recent history of dvt.Also a d dimer should be obtained to see if the patient had a high chance of recurrence of dvt.The patient had a left total knee arthroplasty on (b)(6) 2018 and returned on (b)(6) 2018 it was reported that the patients swelling had been going on since her knee surgeries.On(b)(6) 2018, the patient was educated regarding their diagnosis, prognosis and related pathology.The patient exhibited excellent understanding and performance of the therapeutic activity/instructions outlined during this skilled rehabilitation session.Clinical findings were consistent with a musculoskeletal pattern of impaired joint mobility, motor function, muscle performance, and range of motion associated with joint arthroplasty.On unknown dates, after unknown latencies, the patient experienced left side feels weaker, impaired joint mobility, feeling a lot of pressure, sciatic nerve pain knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isnt where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain.On an unknown date, patient started taking hydrocodone hydrochloride/paracetamol, 1 tablet by oral route every 4-6 hours as needed for pain.On an unknown date, after unknown latency, patient noted some constipation due to hydrocodone hydrochloride/paracetamol.Action taken: unknown for hydrocodone hydrochloride/paracetamol.Corrective treatment: rivaroxaban (xarelto) for dvt; clindamycin for knee joint infection, amlodipine for pain; not reported for rest of the events.Outcome: recovering for impaired joint mobility, pain has drastically increased / new kind of knee pain and joint range of motion decreased/difficulty with forward and lateral step ups with left leg; unknown for rest all events.Seriousness criteria: medically significant and hospitalization for surgery/knee arthroscopy and left total knee arthroplasty, medically significant for dvt/ dvt of left calf, left side feels weaker, knee joint infection and device malfunction.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow up was received on 30-jan-2018.No new information received.Additional information was received on 06-feb-2018.Global ptc number was added.Text amended accordingly.Additional information was received on 08-may-2018 from a physician.Additional events of creaking and popping in knee, pain has drastically increased / new kind of knee pain, joint range of motion decreased, clean out both knees, pain has been in her breast the last few days and feels like muscle tightness and aggravation of bone on bone placed on knee were added.Labs and medical history added.Clinical course was updated.Text amended accordingly.Additional information was received on 08-may-2018 from the medical doctor.Additional events of left side feels weaker, impaired joint mobility, feeling a lot of pressure, knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isnt where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain were added.Suspect product batch number, expiration date and indications were added.Clinical course was updated and text was amended accordingly.Additional information was received on 14-may-2018 from the health care professional.Medical history, concomitant medications were added.Additional suspect product hydrocodone hydrochloride; paracetamol was added along with details.Additional events of lower extremity swelling of bilateral lower extremities, constipation, hypertension, knee effusion, osteoarthritis of both knees, monocytes increased, eosinophils increased, basophil increased, bun high, left total knee arthroplasty and had knee joint infection were added along with details.The event term dvt was updated to dvt/dvt of left calf and surgery was updated to surgery/ knee arthroscope.Laboratory test results were added.Clinical course was updated and text was amended accordingly.Additional information was received on 04-jun-2018.Patients medical history was added.Clinical course was updated and text was amended accordingly.Additional information was received on 01-jun-2018.Medical history and concomitant medications were added.Event of sf nucleated cell count high, polymorhonuclears, mononuclears, was not walking well and sciatic nerve pain were added.Clinical course was updated, and text was amended accordingly.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] surgery [surgery] dvt [dvt] left side feels weaker [weakness left or right side] creaking and popping in knee/feels as if the knee might pop/creaking in left knee/ more crepitus during standing exercises/clicking in the right leg during forward step ups compared to the left [joint crepitation] impaired joint mobility [mobility decreased] knees were pretty stiff/stiffness [stiff knees] pain has drastically increased / new kind of knee pain [knee pain] ([condition aggravated]) joint range of motion decreased/difficulty with forward and lateral step ups with left leg [joint range of motion decreased] pain has been in her breast the last few days and feels like muscle tightness.[breast pain] aggravation of bone on bone placed on knee [knee deformity nos] feeling a lot of pressure [sensation of pressure] weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be [weakness of limbs] impaired muscle performance [muscle disorder nos] leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her [leg pain] ache during standing [difficulty in standing] fatigue [fatigue] back starts to hurt/lower back pain [low back pain] clean out both knees [knee operation] case narrative: this spontaneous case from united states was received on 11-jan-2018 from the nurse.This case concerns 80 years old female patient who initiated treatment with synvisc one and after an unknown latency had a surgery, dvt, creaking and popping in knee, pain has drastically increased / new kind of knee pain, joint range of motion decreased, clean out both knees, pain has been in her breast the last few days and feels like muscle tightness, aggravation of bone on bone placed on knee, left side feels weaker, impaired joint mobility, feeling a lot of pressure, knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain.The patient had medical history of osteoarthritis.No previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017 , patient received treatment with intra articular synvisc one injection once (dose, indication: not provided; batch/ lot number: 7rsl021and expiry date: unknown) for osteoarthritis.On an unknown date after an unknown latency, patient developed a dvt due to surgery (onset and latency: unknown for both) that was necessary as the result of receiving the synvisc one injection.On unknown dates, after unknown latency, the patient was in with orders for pt following knee scope to clean out both knees; after the injection in knees the pain had drastically increased; as the synvisc received was a bad batch the knees had to be cleaned out with in the scope, the patient also developed dvt and was sent to rehab and hoped they could help her function and her balance as well as her knee pain.On unknown dates, after unknown latency, the patient had complaint of left side pain near the breast and voiced the pain had been in her breast the last few days, felt like a muscle tightness, voiced a new kind of knee pain that she experienced the day before when walking but stated it went away and her joint range of motion was decreased.On (b)(6) 2018, bp (blood pressure) was taken after recumbent stepper was complete at 148/80 and again at the end of the day was at 148/76.Patient was advised to contact primary md or secondary md to address chest pain symptoms and continued to have most difficulty with sidelying abduction.Treatment emphasis was to focus on muscle function improvements.On an unknown date, after unknown latency, due to creaking and popping in knee, forward and lateral toe taps arc were added in replacement of steps ups.Toe taps emphasize balance and strength but avoid pressure on the knee joint keeping the knee safe.On (b)(6) 2018, the patient was happy to report her knees were finally feeling better.On (b)(6) 2018, the patient reported having over done it the day before going up and down the stairs so many times.The patient reported that she would like to work on her strength prior to her upcoming knee surgery.The patient had a knee surgery on(b)(6) 2018 and returned on (b)(6) 2018.On (b)(6) 2018, the patient was educated regarding their diagnosis, prognosis and related pathology.The patient exhibited excellent understanding and performance of the therapeutic activity/instructions outlined during this skilled rehabilitation session.Clinical findings were consistent with a musculoskeletal pattern of impaired joint mobility, motor function, muscle performance, and range of motion associated with joint arthroplasty.On unknown dates, after unknown latencies, the patient experienced left side feels weaker, impaired joint mobility, feeling a lot of pressure, knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain.Corrective treatment: rivaroxaban (xarelto) for dvt; not reported for rest of the events.Outcome: recovering for impaired joint mobility, pain has drastically increased / new kind of knee pain and joint range of motion decreased/difficulty with forward and lateral step ups with left leg; unknown for rest all events.Seriousness criteria: important medical event for surgery, dvt, left side feels weaker and device malfunction.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow up was received on 30-jan-2018.No new information received.Additional information was received on 06-feb-2018.Global ptc number was added.Text amended accordingly.Additional information was received on 08-may-2018 from a physician.Additional events of creaking and popping in knee, pain has drastically increased / new kind of knee pain, joint range of motion decreased, clean out both knees, pain has been in her breast the last few days and feels like muscle tightness and aggravation of bone on bone placed on knee were added.Labs and medical history added.Clinical course was updated.Text amended accordingly.Additional information was received on 08-may-2018 from the medical doctor.Additional events of left side feels weaker, impaired joint mobility, feeling a lot of pressure, knees were pretty stiff/stiffness, weakness on the left leg compared to the right leg/leg strength isn't where she would like it to be, impaired muscle performance, leg really hurt /it was the entire leg and could not really provide what kind of pain it was/leg was really bothering her, ache during standing, fatigue and back starts to hurt/lower back pain were added.Suspect product batch number, expiration date and indications were added.Clinical course was updated and text was amended accordingly.
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