| 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
Cyst(s) (1800); Edema (1820); Erythema (1840); Fever (1858); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Reaction, Injection Site (2442); Ambulation Difficulties (2544); No Code Available (3191)
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| Event Date 12/01/2017 |
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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 (b)(6) 2018 from the patient.This case concerns a (b)(6) female patient who initiated treatment with synvisc one and since the same day couldn't walk for about 2 and half week, knee became unbendable, knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock; after an unknown latency had to use a walker for over 2 weeks after the injection, could not bear weight on knee, had terrible pain and pulled fluid out of knee, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications were reported.She takes thyroid medication, blood pressure pills, and a cholesterol pill.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl021; expiry date: unknown).On the same day, knee became swollen, hard as a rock, and unbendable.She called the physician and was told to put ice on it and take aleve.On (b)(6) 2017, she saw her primary care physician near her home.Her pcp pulled 5 cc of fluid out of her knee and sent it for culture.The culture was negative for infection.She denies fever.She was told that she must have received product from the recalled lot, and she also has a letter from the clinic about the recalled lot.After receiving the injection, she could not bear weight on the knee and was in terrible pain.She says she has never had such pain.She had to use a walker for over 2 weeks after the injection.Currently, her knee is still swollen somewhat, and she can walk on it unassisted.After 30 to 45 minutes of being up around the house, her knee starts aching again.Only in the last few days had she been able to put weight on it.She is also able to bend it some now.Corrective treatment: use a walker for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week; aleve, ice for knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock, terrible pain; pulled 5 cc fluid out of knee pulled fluid out of knee outcome: not recovered for knee was swollen about 5 times bigger than usual/ knee became swollen, device malfunction, knee became hard as a rock, terrible pain, pulled fluid out of knee; recovered for had to use a walker for over 2 weeks after the injection and recovering for rest of the events seriousness criteria: disability for had to use a walker for over 2 weeks after the injection and device malfunction 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 08-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot and later her knee became swollen, hard as rock, unbendable, was in terrible pain, could not walk and bear weight on her knee and had to use a walker for over 2 weeks after the injection.A temporal relationship can be established with the product administration.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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Based on additional information received on 12-feb- 2018, the case became medically confirmed (received form physician).This spontaneous case from united states was received on 02-jan-2018 from the patient this case concerns a (b)(6) year old female patient who initiated treatment with synvisc one and since the same day had terrible pain, couldn't walk for about 2 and half week, knee became unbendable, knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock; after an unknown latency had to use a walker for over 2 weeks after the injection, could not bear weight on knee and pulled fluid out of knee, also, device malfunction was identified for the reported lot number.No medical history, previous medications were reported.She takes thyroid medication, blood pressure pills, and a cholesterol pill.The patient had bladder surgery in 1990 and cataract surgery in 2013.The patient was allergic to mold and ragweed.Concomitant medications included atorvastatin calcium, levothyroxine sodium (synthroid), montelukast sodium and hydrochlorothiazide.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl021; expiry date: 31-may-2020) for degenerative joint disease.On the same day, the patient had knee pain after synvisc one injection.On the same day, knee became swollen, hard as a rock, and unbendable.She called the physician and was told to put ice on it and take aleve.On (b)(6) 2017, she saw her primary care physician near her home.Her pcp pulled 5 cc of fluid out of her knee and sent it for culture.The culture was negative for infection.She denies fever.She was told that she must have received product from the recalled lot, and she also has a letter from the clinic about the recalled lot.After receiving the injection, she could not bear weight on the knee and was in terrible pain.She says she has never had such pain.She had to use a walker for over 2 weeks after the injection.Currently, her knee is still swollen somewhat, and she can walk on it unassisted.After 30 to 45 minutes of being up around the house, her knee starts aching again.Only in the last few days had she been able to put weight on it.She is also able to bend it some now.As of (b)(6) 2018, it was reported that the patient still had problem of knee pain.The patient did not visit emergency room and was not admitted in the hospital.Corrective treatment: use a walker for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week; aleve, ice for knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock, terrible pain; pulled 5 cc fluid out of knee pulled fluid out of knee outcome: not recovered for knee was swollen about 5 times bigger than usual/ knee became swollen, device malfunction, knee became hard as a rock, terrible pain, pulled fluid out of knee; recovered for had to use a walker for over 2 weeks after the injection and recovering for rest of the events a product technical complaint (ptc) was initiated with global ptc number: 51724 seriousness criteria: disability for had to use a walker for over 2 weeks after the injection and device malfunction.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 information was received on 31-jan-2018.Global ptc number was added.Additional information was received on 12-feb-2018 form a physician (case became medically confirmed).The patient's concomitant medications, medical history were added.The suspect drug's indication was updated and expiration date was added.The event onset date for the event of had terrible pain was updated.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 13-feb-2018: the follow received does not change the previous assessment of the case.This case concerns a female patient who received synvisc one injection from the recalled lot and later her knee became swollen, hard as rock, unbendable, was in terrible pain, could not walk and bear weight on her knee and had to use a walker for over 2 weeks after the injection.A temporal relationship can be established with the product administration.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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Based on additional information received on 12-feb- 2018, the case became medically confirmed (received form physician).This spontaneous case from united states was received on 02-jan-2018 from the patient this case concerns a 67 year old female patient who initiated treatment with synvisc one and since the same day had terrible pain, couldn't walk for about 2 and half week, knee became unbendable, knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock; after an unknown latency had to use a walker for over 2 weeks after the injection, could not bear weight on knee and pulled fluid out of knee, knee surgery (latency: 10 weeks), unable to work (latency: unknown), reaction to a recalled synvisc one injection (unevaluable event) and also, device malfunction was identified for the reported lot number.No medical history, previous medications were reported.She takes thyroid medication, blood pressure pills, and a cholesterol pill.The patient had bladder surgery in 1990 and cataract surgery in 2013.The patient was allergic to mold and ragweed.Concomitant medications included atorvastatin calcium, levothyroxine sodium (synthroid), montelukast sodium and hydrochlorothiazide.On (b)(6) 2017 , patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl021; expiry date: 31-may-2020) for degenerative joint disease.On the same day, the patient had knee pain after synvisc one injection.On the same day, knee became swollen, hard as a rock, and unbendable.She called the physician and was told to put ice on it and take aleve.On (b)(6) 2017 , she saw her primary care physician near her home.Her pcp pulled 5 cc of fluid out of her knee and sent it for culture.The culture was negative for infection.She denies fever.She was told that she must have received product from the recalled lot, and she also has a letter from the clinic about the recalled lot.After receiving the injection, she could not bear weight on the knee and was in terrible pain.She says she has never had such pain.She had to use a walker for over 2 weeks after the injection.Currently, her knee is still swollen somewhat, and she can walk on it unassisted.After 30 to 45 minutes of being up around the house, her knee starts aching again.Only in the last few days had she been able to put weight on it.She is also able to bend it some now.As of (b)(6) 2018, it was reported that the patient still had problem of knee pain.The patient did not visit emergency room and was not admitted in the hospital.A patient reported that she had a reaction to a recalled synvisc one injection that she received on (b)(6) 2017.See related inquiry(b)(4) on unknown date patient was unable to work since then because she could not walk and then had knee surgery on (b)(6) 2018.Patient was recovering from the knee surgery and was fine.Patient was requesting compensation.No additional information was provided for this report.Corrective treatment: use a walker for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week; aleve, ice for knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock, terrible pain; pulled 5 cc fluid out of knee pulled fluid out of knee; not reported for rest of the events.Outcome: not recovered for knee was swollen about 5 times bigger than usual/ knee became swollen, device malfunction, knee became hard as a rock, terrible pain, pulled fluid out of knee; recovered for had to use a walker for over 2 weeks after the injection, unknown for unable to work and recovering for rest of the events.Seriousness criteria: disability for had to use a walker for over 2 weeks after the injection,couldn't walk for about 2 and half week,device malfunction.A product technical complaint (ptc) was initiated with global ptc number:(b)(4).Seriousness criteria: disability for had to use a walker for over 2 weeks after the injection and device malfunction 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 information was received on 31-jan-2018.Global ptc number was added.Additional information was received on 12-feb-2018 form a physician (case became medically confirmed).The patient's concomitant medications, medical history were added.The suspect drug's indication was updated and expiration date was added.The event onset date for the event of had terrible pain was updated.Clinical course was updated.Text was amended accordingly.Additional information was received on 30-mar-2018 from patient.Events of reaction to a recalled synvisc one injection, knee surgery and unable to work was added with details.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 30-mar-2018: this case concerns a female patient who received synvisc one injection from the recalled lot and later her knee became swollen, hard as rock, unbendable, was in terrible pain, had a knee surgery and had impaired work ability could not walk and bear weight on her knee and had to use a walker for over 2 weeks after the injection.A temporal relationship can be established with the product administration.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] terrible pain; aches; sharp/lot of pain/ more sore/right knee pain [knee pain] ([condition worsened]) had to use a walker for over 2 weeks after the injection [walking aid user] couldn't walk for about 2 and half week/ can hardly walk/inability to ambulate [unable to walk] unable to work [impaired work ability] reaction to a recalled synvisc one injection [unevaluable event] mchc low at 31.1 [mean cell haemoglobin concentration low] barely move her toes [movements reduced] synovial fluid color yellow [synovial fluid analysis abnormal] synovial fluid clarity/appearance [synovial fluid analysis] synovial fluid rbc 15000/ul [synovial fluid red blood cells] synovial fluid nucleated cell count 13151/ul; high [synovial fluid analysis abnormal] synovial fluid polymorphonuclear percenatge high/ lymphocytes present/ monocytes present/ macrophages increased [synovial fluid white blood cells positive] nausea [nausea] low grade temperature [temperature elevation] hypersensitivity reaction [hypersensitivity reaction] knee became unbendable [joint range of motion decreased] could not bear weight on knee [weight bearing difficulty] erythema [erythema] bakers cyst [baker's cyst] ([twitching flexor]) knee was swollen about 5 times bigger than usual/ knee became swollen/blew up the knee/gross swelling [swelling of r knee] knee became hard as a rock/ more tight [stiff knees] pulled fluid out of knee/ pull off about 5cc of fluid/effusion of knee [effusion (r) knee] case narrative: based on additional information received on 12-feb-2018, the case became medically confirmed (received form physician).This spontaneous case from united states was received on 02-jan-2018 from the patient this case concerns a 67 year old female patient (162cm and 104kg) who initiated treatment with synvisc one and since the same day had terrible pain/ aches; sharp/lot of pain/ more sore/right knee pain, couldn't walk for about 2 and half week/can hardly walk/inability to ambulate, knee became unbendable, knee was swollen about 5 times bigger than usual/ knee became swollen/ blew up the knee, knee became hard as a rock/ more tight; barely move her toes (latency: same day); after an unknown latency had to use a walker for over 2 weeks after the injection; could not bear weight on knee and pulled fluid out of knee synovial fluid color yellow, synovial fluid clarity/appearance, synovial fluid rbc 15000/ul, synovial fluid nucleated cell count 13151/ul, synovial fluid polymorphonuclear percenatge high/ lymphocytes present/ monocytes present/ macrophages increased, hypersensitivity reaction, mchc low at 31.1 (latency: 2 days); unable to work (latency: unknown), reaction to a recalled synvisc one injection (unevaluable event) and also, fever (latency: 2 months), bakers cyst (latency: 1 month 26 days), erythema (latency: unknown); device malfunction was identified for the reported lot number.Patient's medical history included hypersensitivity to smoke (cigarettes), mold and ragweed, cervicitis, obesity, musculoskeletal pain, fall, arthralgia, crepitations, contusion with left knee, peritonsillar abscess on, haematochezia, polypectomy, rheumatoid arthritis, hyperlipidaemia, large intestine benign neoplasm, diverticulum intestinal, haemorrhoids, abnormal faeces, body mass index abnormal, large intestine polyp, osteoarthritis, bronchial hyperreactivity, colon adenoma, urinary incontinence, stress, urinary incontinence, colonoscopy, polypectomy, delivery, hypertriglyceridaemia, rotator cuff syndrome, pain in extremity and arthralgia.The patient was a non-tobacco user, abstains from alcohol and other recreational drugs.The patient is a denture wearer.Patient's past medical treatments involved bladder surgery in 1990, history of surgery in 1990, history of hospitalization 1991, cataract surgery 2013, cataract operation and intraocular lens implant in 2013.Other treatments involved tetanus vaccine on (b)(6) 2005, flu vaccine vii (trivalent single dose (fluvirin, afluria)), on (b)(6) 2010 and on (b)(6) 2012, h1n1 vaccine in 1976, monovalent on (b)(6) 2010 and on (b)(6) 2010: h1n1 vaccine w/preservative 3yr+, influenza vaccine on (b)(6) 2009, pneumococcal conjugate vaccine on (b)(6) 2017 and zostavax on (b)(6) 2013.Patients family history included leukaemia with father, diabetes mellitus with sister and brother, hypertension with brother and hypothyroidism with mother and sister, asthma with father and children, stargardt's disease with mother, lung neoplasm malignant with brother, breast cancer with sister and cardiac valve disease with brother.Concomitant medications included atorvastatin calcium (atorvastatin calcium); levothyroxine sodium (synthroid) for hypothyroidism; montelukast sodium (montelukast sodium); hydrochlorothiazide (hydrochlorothiazide); acetaminophen (acetaminophen) for dyspnoea; hydrochlorothiazide (hydrochlorothiazide); naproxen; levothyroxine, albuterol mdi, blood pressure pills and a cholesterol pill.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl021; expiry date: 31-may-2020) for degenerative joint disease and return of knee pain.On the same day, the patient had knee pain/ aches; sharp/lot of pain/ more sore after synvisc one injection.On the same day, knee became swollen/ knee became swollen/blew up the knee, hard as a rock/ more tight, and unbendable.She called the physician and was told to put ice on it and take aleve.On (b)(6) , she saw her primary care physician near her home.Her pcp pulled 5 cc of fluid out of her knee and sent it for culture.The synovial fluid analysis depicted following findings: synovial fluid color yellow, synovial fluid clarity/appearance, synovial fluid rbc 15000/ul, synovial fluid nucleated cell count 13151/ul, synovial fluid polymorphonuclear percentage high/ lymphocytes present/ monocytes present/ macrophages increased.The other lab reports revealed that mchc was low at 31.1.The same day, it was reported to be a hypersensitivity reaction that had occurred in the knee with the synvisc one injection.The culture was negative for infection and bacterial finding.She denies fever.She was told that she must have received product from the recalled lot, and she also has a letter from the clinic about the recalled lot.After receiving the injection, she could not bear weight on the knee and was in terrible pain.She says she has never had such pain.She had to use a walker for over 2 weeks after the injection.Currently, her knee is still swollen somewhat, and she can walk on it unassisted.After 30 to 45 minutes of being up around the house, her knee starts aching again.Only in the last few days had she been able to put weight on it.She is also able to bend it some now.On (b)(6) 2018, patient reported to the clinic with complaint of right knee pain, gross swelling, erythema and inability to ambulate and risks and benefits of undergoing a total knee arthroscopy in the future were discussed with the patient.She reported that the erythema resolved on its own.Further, the patient had a bakers cyst (latency: 1 month 26 days), she had effusion of the knee with flexion on contracture.As of (b)(6) 2018, it was reported that the patient still had problem of knee pain.The patient did not visit emergency room and was not admitted in the hospital.A patient reported that she had a reaction to a recalled synvisc one injection that she received on 12-dec-2017.See related inquiry (b)(4) on unknown date patient was unable to work since then because she could not walk.On (b)(6) 2018, the patient underwent total knee arthroscopy procedure.On the same day, the patient also reported having nausea.The patient was taken to operating room and the right leg was prepped and draped for surgery in usual sterile fashion.A longitudinal incision was made and the knee was cut open.Electrocautery was used for hemostasis and the synovial fluid was evacuated including the soft tissues of the fat pad, anterior horn of medial meniscus, leg was pulled out to full extension and patella was inverted and reamed down to 14mm thickness, after this the patella was pushed back to position and was retractors were placed.An osteotome was used and small amount of bone was removed.Subsequently, the patella was sized to a 34 patellar button, drill was positioned, holes were made and trial patella was placed.The knee was put through range of motion and after finding goof tracking and stability, all the trial components were removed.The wound was irrigated and area was dried.Palacos cement was placed on on tibial and femoral compartments.The knee was then closed with vicryl sutures and skin was closed with staples.Wound was cleaned and dried and dressed with xeroform gauze.Patient was sent to recovery room in stable condition.On (b)(6) 2018, the patient had low grade temperature.It was reported that the gross feeling and erythema eventually resolved on their own.The patient had increased problems with her knee since that time.They were per-articular osteophytes and subchondral cysts identified throughout the knee.The patient had instability with carus/ valgus stressing with tenderness to the medial joint line and popliteal fossa.The patient has a baker's cyst i.E., effusion of the knee and had a slight flexion contracture.The patient had continued care with physical therapy.The patient was doing better and was bending her knee well.On (b)(6) 2018, the patient was discharged from the hospital.On (b)(6) 2018, patient reported to the hospital for her post surgery follow up.On examination it was observed that her wound was healing well and patient was receiving physical therapy for the same.On (b)(6) 2018 patient returned again for follow up on her knee arthroscopy.The wound had healed well and is now 3 months out.The extension and strength was great and did not have much pain post surgery.Final diagnosis was terrible pain; aches; sharp/lot of pain/ more sore, knee became hard as a rock/ more tight, knee was swollen about 5 times bigger than usual/ knee became swollen/blew up the knee, knee became unbendable, couldn't walk for about 2 and half week/ can hardly walk, device malfunction, hypersensitivity reaction, synovial fluid polymorphonuclear percentage high/ lymphocytes present/ monocytes present/ macrophages increased, synovial fluid nucleated cell count 13151/ul; high, synovial fluid rbc 15000/ul, synovial fluid clarity/appearance, synovial fluid color yellow, pulled fluid out of knee/ pull off about 5cc of fluid, mchc low at 31.1, nausea, low grade temperature, could not bear weight on knee, barely move her toes, had to use a walker for over 2 weeks after the injection, reaction to a recalled synvisc one injection and unable to work.Corrective treatment: use a walker for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week; aleve, ice for knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock/ more tight, terrible pain/ aches; sharp/lot of pain/ more sore; pulled 5 cc fluid out of knee pulled fluid out of knee, aspirin hydrocodone, colase, tylenol arthritis, fluticasone (flucitasone); total knee replacement, toradol, zofran for terrible pain/ aches; sharp/lot of pain/ more sore/right knee pain; not reported for rest of the events.Outcome: recovered for had to use a walker for over 2 weeks after the injection, erythema, bakers cyst; not recovered for device malfunction, knee was swollen about 5 times bigger than usual/ knee became swollen/blew up the knee, knee became hard as a rock/ more tight, terrible pain/ aches; sharp/lot of pain/ more sore/right knee pain, condition worsened on bending and walking, pulled fluid out of knee/ pull off about 5cc of fluid; recovering for couldn't walk for about 2 and half week/ can hardly walk/inability to abulate, total knee replacement, knee became unbendable, could not bear weight on knee and unknown for mchc low at 31.1, nausea, low grade temperature, unable to work, barely move her toes, synovial fluid color yellow, synovial fluid clarity/appearance, synovial fluid rbc 15000/ul, as synovial fluid nucleated cell count 13151/ul high, synovial fluid polymorphonuclear percenatge high/ lymphocytes present/ monocytes present/ macrophages increased and hypersensitivity reaction.Seriousness criteria: disability for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week/can hardly walk/inability to ambulate, device malfunction, hospitalization for surgery (total knee replacement) for terrible pain/ aches; sharp/lot of pain/ more sore/right knee pain.A product technical complaint (ptc) was initiated with global ptc number: (b)(4).Seriousness criteria: disability for had to use a walker for over 2 weeks after the injection and device malfunction.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 information was received on 31-jan-2018.Global ptc number was added.Additional information was received on 12-feb-2018 form a physician (case became medically confirmed).The patient's concomitant medications, medical history were added.The suspect drug's indication was updated and expiration date was added.The event onset date for the event of had terrible pain was updated.Clinical course was updated.Text was amended accordingly.Additional information was received on 30-mar-2018 from patient.Events of reaction to a recalled synvisc one injection, knee surgery and unable to work was added with details.Clinical course was updated.Text was amended accordingly.Follow-up information was received on 11-apr-2018.No new information was received.Additional information was received on 30-jul-2018.New events of mchc low at 31.1, nausea, low grade temperature, barely move her toes, synovial fluid color yellow, synovial fluid clarity/appearance, synovial fluid rbc 15000/ul, as synovial fluid nucleated cell count 13151/ul high, synovial fluid polymorphonuclear percenatge high/ lymphocytes present/ monocytes present/ macrophages increased and hypersensitivity reaction were added.Event verbatim of knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock, terrible pain/ aches; sharp was updated to knee was swollen about 5 times bigger than usual/ knee became swollen/blew up the knee, knee became hard as a rock/ more tight, terrible pain/ aches; sharp/lot of pain/ more sore.Medical history, surgical history and family history were added.Event of terrible pain/ aches; sharp/lot of pain/ more sore was updated to serious due to event of surgical procedure of total knee replacement as corrective.Additional indication for suspect of return of knee pain was added.Clinical course was updated.Text was amended accordingly.Additional information received on 27-aug-2018 from healthcare professional.Details of patients weight and height added.Event of erythema added with details.Event verbatims updated for terrible pain; aches; sharp/lot of pain/ more sore to terrible pain; aches; sharp/lot of pain/ more sore/right knee pain and couldn't walk for about 2 and half week/ can hardly walk to couldn't walk for about 2 and half week/ can hardly walk/inability to ambulate; knee was swollen about 5 times bigger than usual/ knee became swollen/blew up the knee to knee was swollen about 5 times bigger than usual/ knee became swollen/blew up the knee/gross swelling with details of corrective treatment of total knee arthroscopy added.Clinical course updated.Text amended accordingly.
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