|
Using crutches due to pain [walking aid user].Knee effusion / 20 cc of yellow fluid was removed [knee effusion].Weight bearing difficulty [weight bearing difficulty].Joint range of motion decreased [joint range of motion decreased].Tingling [tingling].Pseudo septic reaction / bacterial infection [bacterial infection].Interfering all activities of daily living / unable to move out of bed [activities of daily living impaired].Knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee.[knee pain] ([condition aggravated]).Knee swelling [knee swelling].Burning / heat from her lower extremity/knee/ calf area [joint warmth].Inflammation [joint inflammation].An adverse reaction [unevaluable event].Case narrative: based on information received on (b)(6) 2018 from doctor, the report previously considered as non-valid became due to the addition of adverse event of knee effusion / 20 cc of yellow fluid was removed, using crutches due to pain, weight bearing difficulty, joint range of motion decreased, tingling, pseudo septic reaction / bacterial infection, interfering all activities of daily living / unable to move out of bed, knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee, knee swelling, burning / heat from her lower extremity/knee/ calf area and inflammation and this case initially considered as non-serious was upgraded to serious due to the seriousness criteria of required intervention for knee effusion / 20 cc of yellow fluid was removed and disability for using crutches due to pain and also the case became medically confirmed.This spontaneous case from united states was received on (b)(6) 2018 from patient.This case concerns a (b)(6) years old female patient who initiated treatment with synvisc one and after an unknown latency had an adverse reaction.Concomitant medications included cortisone.No medical history, previous medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6ml, (frequency: not provided; batch/ lot number and expiry date: unknown) for primary osteoarthritis.On (b)(6) 2017, few hours after the injection, the patient experienced left and right knee pain which was associated with synvisc injections.This was her second time getting the injections.Her pain slowly increased.She tried icing and anti-inflammatories.On an unknown date after an unknown latency, she had an adverse reaction.On an unknown date in (b)(6) 2017, few days after the first infusion, the patient was now using crutches due to the pain.The pain was a 10 on a scale of 1-10.Patient described the pain as burning, sharp and stabbing and it was located all around the knees.On an unknown date in (b)(6) 2017, few days after the first infusion, it was made worse by weight bearing, bending and it was made better by ice, elevation.On an unknown date in (b)(6) 2017, few days after the first infusion, the patient had full range of motion however limited slightly in flexion due to swelling.On (b)(6) 2018, muscle strength was +5/5.Sensation was intact.Negative lachman, anterior drawer, and mcmurray's.No instability or laxity with varus or valgus stress tests.+2 effusion was noted.On the same day, 12 days after the first infusion, the patient after a comprehensive discussion of risks and options, verbal consent was obtained for an aspiration and injection.Under sterile conditions, approximately 20cc of yellow fluid was removed, 2 ml/14 mg of betamethasone was injected with 3 cc of bupivacaine hydrochloride (marcaine) and 3 cc of lidocaine.The patient tolerated the procedure well.Instructions were given to the patient on post injection care.The injection was given into the left knee and info the right knee.On an unknown date after unknown latency, patient complained of burning, tingling and heat from her left lower extremity/knee/calf area.She has been taking anti-inflammatories.The pain was 8-9 on a scale of 1 -10.On (b)(6) 2017, she had a synvisc reaction 1 month ago with a cortisone injection.She reports continued pain in the left knee.The right knee had since mostly resolved.The cortisone injection worked for a short time.Patient was recommended the following plan of an oral anti-inflammatories, naproxen (vimovo).Patient should continue to modify activities as needed.She would use ice as needed.She will follow up in 1 month.On an unknown date after unknown latency, the patient developed a pseudo septic reaction after the injections.Having said that, there was a recall lot the synvisc lot that they used on her that may have a bacterial infection and so she was here today tor consideration of an aspiration.On (b)(6) 2018, patient had not been on antibiotics and so she did give her prescription for sulfamethoxazole/trimethoprim (bactrim ds) today.This was tor 2 weeks.She was going to see the infectious disease doctor in the meantime.They did discuss the possibility of doing an aspiration but based on my physical exam today they don't think there was any fluid in either of her knees and so they were not sure that going in there with the needle and digging around looking for fluid was the greatest thing to do and so they were going to hold off and just treat her on antibiotics.They would see her back after she sees the infectious disease doctor.On (b)(6) 2018, patient was placed on to oral antibiotics.She continued to have sharp pains in the inside of the right knee.She had tried naproxen (vimovo) and had been using ice and elevating.The pain was a 10 on a scale of 1 -10.She described the pain as sharp and was located in the medial knee.It was made worse by everything and it was made better by nothing.It was interfering all activities of daily living (onset date: unknown; latency: unknown).They would recommend sending the patient for an mri to evaluate for a meniscus tear as well as other intra-articular pathology.The patient does understand that if there was a tear or other intra-articular pathology that was contributing to the patient's pain, operative intervention would likely be recommended.This would include a diagnostic and operative arthroscopy of the knee with correction ot the internal derangement.After review of the mri, continued conservative treatment may also be considered.This treatment may include a steroid injection and/or physical therapy.Doctor would see the patient back after their mri.On (b)(6) 2018, the pain was a 10 on a scale of 1-10.Patient described the pain as sharp and it was located in the right knee.It was made worse by walking, standing, sitting and it was made better by nothing helps the pain.She denied numbness and tingling.She had most of these issues after her synvisc injection which was the potentially tainted patch.She did apparently have some labs done recently which were ordered by doctor of infectious disease.She had not had an aspiration.She had a synvisc injection after words she had relief and over time she had severe inflammation and was unable to get out of bed due to the severe pain.No treatment had helped relieve the pain.As per mri done, underlying tricompartmental osteoarthritic changes were present which appear somewhat more prominent particularly regarding the medial joint, suspect subtle tear through the medial meniscus at the root attachment, subtle oblique tear through the posterior horn lateral meniscus and chondromalacia patella.It was reported that certainly with the elevated blood work that she had them need to consider aspiration to make sure she did not have an infection.Having said that, patient does not tolerate aspirations very well and asked about possibly doing some anesthesia tor the aspiration and as they showed her on her mri as well as based on exam she really does not have much fluid inside of her knee so they think it would be a difficult aspiration.It would be reasonable to do an arthroscopic surgery with clean up of her meniscus tears on the medial and lateral side and they would also do an aspiration to get some fluid sample to send tor culture results.On (b)(6) 2018, a diagnostic and operative arthroscopy of right knee with partial medial meniscectomy was done.After failing conservative measures, the patient elected to undergo a diagnostic operative arthroscopy of the right knee.The patient in stable condition.Corrective treatment: betamethasone, lidocaine, bupivacaine hydrochloride for knee effusion / 20 cc of yellow fluid was removed; not reported for an adverse reaction, interfering all activities of daily living / unable to move out of bed, using crutches due to pain; ice, elevation for weight bearing difficulty; anti-inflammatories, rest, ice, elevation for joint range of motion decreased; naproxen (vimovo), ice for tingling and burning / heat from her lower extremity/knee/ calf area; sulfamethoxazole/trimethoprim for pseudo septic reaction / bacterial infection; icing, anti-inflammatories, crutches for knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee.; anti-inflammatories, rest, ice, elevation for knee swelling; ice for inflammation.Outcome: not recovered/ not resolved for knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee; recovered/ resolved for tingling; unknown for rest of the events.Seriousness criteria: required intervention for knee effusion / 20 cc of yellow fluid was removed and disability for using crutches due to pain.A product technical complaint was initiated with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information was received on (b)(6) 2018.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from doctor.The report previously considered as non-valid became due to the addition of adverse event of knee effusion / 20 cc of yellow fluid was removed, using crutches due to pain, weight bearing difficulty, joint range of motion decreased, tingling, pseudo septic reaction / bacterial infection, interfering all activities of daily living / unable to move out of bed, knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee, knee swelling, burning / heat from her lower extremity/knee/ calf area and inflammation and this case initially considered as non-serious was upgraded to serious due to the seriousness criteria of required intervention for knee effusion / 20 cc of yellow fluid was removed and disability for using crutches due to pain and also the case became medically confirmed.Event of knee effusion / 20 cc of yellow fluid was removed, using crutches due to pain, weight bearing difficulty, joint range of motion decreased, tingling, pseudo septic reaction / bacterial infection, interfering all activities of daily living / unable to move out of bed, knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee, knee swelling, burning / heat from her lower extremity/knee/ calf area and inflammation were added with details.Action taken was updated.Patient's age was updated.Seriousness criteria was added.Patient's age was added.Therapy start date, dose and indication were added.Lab test was added.Concomitant was added.Clinical course updated.Text was amended accordingly.
|
|
Device malfunction [device malfunction] could not walk or stand [walking difficulty] could not walk or stand [difficulty in standing] pseudo septic reaction [pseudosepsis] ([knee effusion], [knee pain], [knee swelling], [joint warmth], [joint inflammation], [synovial fluid analysis abnormal], [synovial fluid white blood cells positive], [sedimentation rate increased], [c-reactive protein increased], [condition aggravated]) weight bearing difficulty [weight bearing difficulty] joint range of motion decreased [joint range of motion decreased] tingling [tingling] interfering all activities of daily living / unable to move out of bed [activities of daily living impaired] an adverse reaction [unevaluable event] pain in lower leg below knee/positive for extremity pain [pain in leg] numbness, weakness and buring on lateral aspect of both lower legs [numbness in leg] numbness, weakness and buring on lateral aspect of both lower legs [lower extremities weakness of] numbness, weakness and buring on lateral aspect of both lower legs [extremities burning sensation of] knees get red [redness] cold [cold] creatinine low [creatinine low] ast low [ast low] rdw increased [rdw increased] case narrative: based on information received on (b)(6) 2018 from doctor, the report previously considered as non-valid became due to the addition of adverse event of knee effusion / 20 cc of yellow fluid was removed, using crutches due to pain, weight bearing difficulty, joint range of motion decreased, tingling, pseudo septic reaction / bacterial infection, interfering all activities of daily living / unable to move out of bed, knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee, knee swelling, burning / heat from her lower extremity/knee/ calf area and inflammation and this case initially considered as non-serious was upgraded to serious due to the seriousness criteria of required intervention for knee effusion / 20 cc of yellow fluid was removed and disability for using crutches due to pain and also the case became medically confirmed.This spontaneous case from united states was received on (b)(6) 2018 from patient.This case concerns a 50 years old female patient who initiated treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced could not walk or stand, pseudo septic reaction,weight bearing difficulty,joint range of motion decreased,tingling, interfering all activities of daily living / unable to move out of bed, an adverse reaction, pain in lower leg below knee/positive for extremity pain,numbness, weakness and buring on lateral aspect of both lower legs, knees get red, cold(latency: unknown), creatinine low, ast low, rdw increased (latency: 1 month 7 days).Additionally, event of device malfunction was added for the identified lot number.The patient's past medical history included knee arthroscopy in (b)(6) 2015, ankle surgery in 2015, displacement of intervetebral disc without myelopathy, lumbosacral spondolysis without myelopathy, spinal stenosis of lumbar region, achilles bursitis, juvenile osteochondrosis of foot, localised primary osteoarthritis of lower leg, exostosis, arthralgia of ankle and/or foot, calcium deposits in tendon, hysteroscopy on (b)(6) 2014, osteotomy calcaneus on (b)(6) 2015 (w/ or w/) internal fixation), knee achy and pain, dialtion and curettage of uterus on (b)(6) 2014, repair of meniscus tear of knee.Patient was a former smoker (stop date: (b)(6) 2007).The patient's past vaccination(s) included influenza on (b)(6) 2012 and tdap on (b)(6) 2008.The patient's family history included type 2 diabetes mellitus with patients father also has history of type 2 diabetes and had coronary artery disease, hyperlipidemia with mother and hypertension with mother, maternal grandmother.The patient's past medical treatment(s) was not provided.At the time of event patient had ongoing high blood pressure, type 2 diabetes, degeneration of lumbar vertebrae/degenration of lumab or lubosacral intervertebral disc, amoxicillin allergy (amoxicillin causes of vaginal yeast infection and not a rash), allergy to lisinopril, anxiety disorder, benign essential hypertension, esophageal reflux, obstructive sleep apnea, mixed hyperlipidemia, essential hypertension, pure hyperglyceridemia, obesity, degeneration of cervical intervertebral disc, symptom associated with female genital organs, osteoarthritis of knees.Concomitant medications included cortisone; lorazepam (ativan) for anxiety; metformin hydrochloride (glucophage); omeprazole; atenolol; vitamin d nos; and hydrochlorothiazide, sulfamethoxazole;trimethoprim, sertraline hydrochloride (zoloft).On (b)(6) 2017, patient received treatment with intra articular hylan g-f 20, sodium hyaluronate injection at a dose of 6ml 1x, (batch: 7rsl021; exp (b)(6) 2020) for primary osteoarthritis in both knees.On (b)(6) 2017 (about 06:00 pm), few hours after the injection, the patient experienced excruciating left and right knee pain which was associated with hylan g-f 20, sodium hyaluronate injections.This was her second time getting the injections.Her pain slowly increased.She tried icing and anti-inflammatories.Patient called her physician and symptomatic treatment was recommended.On an unknown date after an unknown latency, she had an adverse reaction.On an unknown date in (b)(6) 2017, few days after the first injection, patient noted that she could not walk was now using crutches due to the pain.The pain was a 10 on a scale of 1-10.Patient described the pain as burning, sharp and stabbing and it was located all around the knees.On an unknown date in (b)(6) 2017, few days after the first injection, it was made worse by weight bearing, bending and it was made better by ice, elevation.On an unknown date in (b)(6) 2017, few days after the first injection, the patient had full range of motion however limited slightly in flexion due to swelling.On (b)(6) 2017, patient's creatine was 0.53 (low), red cell distribution width was 15.6 (high) and aspartate aminotransferase was 12 (low) (latency: 1 month 7 days).On (b)(6) 2017, muscle strength was +5/5.Sensation was intact.Negative lachman, anterior drawer, and mcmurray's.No instability or laxity with varus or valgus stress tests.+2 effusion was noted; also the lab tests for synovial fluid were performed which were abnormal.On the same day, 12 days after the first infusion, the patient after a comprehensive discussion of risks and options, verbal consent was obtained for an aspiration and injection.Under sterile conditions, approximately 20cc of yellow fluid was removed from left knee, 2 ml/14 mg of betamethasone was injected with 3 cc of bupivacaine hydrochloride (marcaine) and 3 cc of lidocaine.The patient tolerated the procedure well.Instructions were given to the patient on post injection care.The injection was given into the left knee and info the right knee.The synovial fluid analysis showed 23,323 white cells and 76 % neutrophils and the culture was negative.Patient reported that the betamethasone injection did not help.On an unknown date after unknown latency, patient complained of burning, tingling and heat from her left lower extremity/knee/calf area.She has been taking anti-inflammatories.The pain was 8-9 on a scale of 1 -10.On (b)(6) 2017, she had a hylan g-f 20, sodium hyaluronate reaction 1 month ago with a cortisone injection.She reports continued pain in the ieft knee.The right knee had since mostly resolved.The cortisone injection worked for a short time.Patient was recommended the following plan of an oral anti-inflammatories, naproxen (vimovo).Patient should continue to modify activities as needed.She would use ice as needed.She will follow up in 1 month.On an unknown date after unknown latency, the patient developed a pseudo septic reaction after the injections.Having said that, there was a recall lot the synvisc lot that they used on her that may have a bacterial infection and so she was here today tor consideration of an aspiration.On (b)(6) 2018, patient had not been on antibiotics and so she did give her prescription for sulfamethoxazole/trimethoprim (bactrim ds) today.This was tor 2 weeks.She was going to see the infectious disease doctor in the meantime.They did discuss the possibility of doing an aspiration but based on my physical exam today they don't think there was any fluid in either of her knees, no knee effusions were there and so they were not sure that going in there with the needle and digging around looking for fluid was the greatest thing to do and so they were going to hold off and just treat her on antibiotics.They would see her back after she sees the infectious disease doctor.On an unknown date in (b)(6) 2018 (last week from (b)(6) 2018), patient had cold and seen by primary care physician.On (b)(6) 2018, patient described numbness, weakness and burring on the lateral aspect of both lower legs (onset and latency: unknown), stated that knees swell and get red and she had constant pain.Patient was also positive for extremity pain and was nervous/anxious.Left knee had mild warmth laterally, full range of motion, noted no erythema no swelling and right knee without warmth swelling or erythema.On (b)(6) 2018, patient was placed on to oral antibiotics.She continued to have sharp pains in the inside of the right knee.She had tried naproxen (vimovo) and had been using ice and elevating.The pain was a 10 on a scale of 1 -10.She described the pain as sharp and was located in the medial knee.It was made worse by everything and it was made better by nothing.It was interfering all activities of daily living (onset date: unknown; latency: unknown).They would recommend sending the patient for an mri to evaluate for a meniscus tear as well as other intra-articular pathology.The patient does understand that if there was a tear or other intra-articular pathology that was contributing to the patient's pain, operative intervention would likely be recommended.This would include a diagnostic and operative arthroscopy of the knee with correction of the internal derangement.After review of the mri, continued conservative treatment may also be considered.This treatment may include a steroid injection and/or physical therapy.Doctor would see the patient back after their mri.On (b)(6) 2018, lab results of the patient revealed eosinophil percentage increased as 7.5% (ref range: 0-7.3) and c-reactive protein as 2.44mg/dl (ref range: 0-1) (high), sedimentation rate was 48 mm/hr (high; reference range: 0-30 mm/hr).It was reported that elevated sedimentation rate and c reactive protein would be consistent with inflammatory or infectious response.On (b)(6) 2018, the pain was a 10 on a scale of 1-10.Patient described the pain as sharp and it was located in the right knee.It was made worse by walking, standing, sitting and it was made better by nothing helps the pain.She denied numbness and tingling.She had most of these issues after her synvisc injection which was the potentially tainted patch.She did apparently have some labs done recently which were ordered by doctor of infectious disease.She had not had an aspiration.She had a synvisc injection after words she had relief and over time she had severe inflammation and was unable to get out of bed due to the severe pain.No treatment had helped relieve the pain.As per mri done, underlying tricompartmental osteoarthritic changes were present which appear somewhat more prominent particularly regarding the medial joint, suspect subtle tear through the medial meniscus at the root attachment, subtle oblique tear through the posterior horn lateral meniscus and chondromalacia patella.It was reported that certainly with the elevated blood work that she had them need to consider aspiration to make sure she did not have an infection.Having said that, patient does not tolerate aspirations very well and asked about possibly doing some anesthesia tor the aspiration and as they showed her on her mri as well as based on exam she really does not have much fluid inside of her knee so they think it would be a difficult aspiration.It would be reasonable to do an arthroscopic surgery with clean up of her meniscus tears on the medial and lateral side and they would also do an aspiration to get some fluid sample to send tor culture results.On (b)(6) 2018, a diagnostic and operative arthroscopy of right knee with partial medial meniscectomy was done.After failing conservative measures, the patient elected to undergo a diagnostic operative arthroscopy of the right knee.The patient in stable condition.On (b)(6) 2018, patient reported to the hospital after failing nonoperative conservative management for refractory right knee pain with associated mechanical symptoms and elected for surgical intervention.After conducting a detailed physical examination patient was prepared for operative knee arthroscopy with partial medial menistectomy.The patient was administered bupivacaine, fentanyl, cephazolin, lidocaine, midazolam, morphine pf injection and lactated ringers as pre-operative medications.The patient was brought to the operating suite and given general anesthesia.The right knee was prepped and draped in the normal sterile fashion.A tourniquet was applied around his upper thigh.The right leg was exsanguinated with the use of a 6-inch esmarch.A 0.5 cm incision was made over the inferior aspect of the lateral patella.A blunt trocar followed, then the camera.The knee was insufflated with normal saline solution.A thorough inspection of all compartments was made and this was what was found.Patellofemoral joint was found to have grade 3-4 degenerative changes and marked friable articular cartilage.Medial compartment was found to have grade 4 degenerative changes and focal area of cartilage loss, shredded tear of the body extending to the posterior horn of the medial meniscus.Acl and pcl were found to be intact.The lateral compartment was found to have grade 2 changes.No meniscal tear.A second incision was made about the inferior aspect of the medial patella.A blunt trocar followed, then the probe.Confirmation of diagnosis was made with the use of the probe.A 3.5 shaver was then introduced in the knee and a partial medial meniscectomy was performed.Smooth stable contour was obtained.The knee was thoroughly irrigated.All trocars were removed.Incisions were closed using mastisol and steri-strips.The knee was then thoroughly irrigated.All trocars were removed.The incisions were closed with 3-0 nylon in an interrupted fashion.A sterile dressing was applied.Corrective treatment: bacterim ds, icing, anti-inflammatories, crutches, right knee operative arthroscopy, betamethasone for pseudo septic reaction; crutches for could not walk or stand; ice and elevation for weight bearing difficulty, anti inflammatories, rest, ice, elevation for joint range of motion decreased; vimovo, ice for tingling; unknown for interfering all activities of daily living / unable to move out of bed; not reported for rest of the events outcome: not recovered/ not resolved for pseudo septic reaction; recovered/ resolved for tingling; unknown for rest of the events seriousness criteria: required intervention and disability for pseudo septic reaction and device malfunction; disability for could not walk or stand.A product technical compliant was initiated with global ptc number: 52166.An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on (b)(6) 2018.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from doctor.The report previously considered as non-valid became due to the addition of adverse event of knee effusion / 20 cc of yellow fluid was removed, using crutches due to pain, weight bearing difficulty, joint range of motion decreased, tingling, pseudo septic reaction / bacterial infection, interfering all activities of daily living / unable to move out of bed, knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee, knee swelling, burning / heat from her lower extremity/knee/ calf area and inflammation and this case initially considered as non-serious was upgraded to serious due to the seriousness criteria of required intervention for knee effusion / 20 cc of yellow fluid was removed and disability for using crutches due to pain and also the case became medically confirmed.Event of knee effusion / 20 cc of yellow fluid was removed, using crutches due to pain, weight bearing difficulty, joint range of motion decreased, tingling, pseudo septic reaction / bacterial infection, interfering all activities of daily living / unable to move out of bed, knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee, knee swelling, burning / heat from her lower extremity/knee/ calf area and inflammation were added with details.Action taken was updated.Patient's age was updated.Seriousness criteria was added.Patient's age was added.Therapy start date, dose and indication were added.Lab test was added.Concomitant was added.Clinical course updated.Text was amended accordingly.Additional information received on (b)(6) 2018 from healthcare professional.Patient's medical history of hypertension, arthroscopy, surgery, intervertebral disc disorder, intervertebral disc displacement, spondylolysis, lumbar spinal stenosis, tendonitis, osteochondrosis, osteoarthritis, exostosis, arthralgia, calcinosis, drug hypersensitivity, tobacco use, drug hypersensitivity, anxiety disorder, essential hypertension, gastrooesophageal reflux disease, sleep apnoea syndrome, type v hyperlipidaemia, essential hypertension, hypertriglyceridaemia, obesity, hysteroscopy and osteotomy added.Event of synovial fluid analysis abnormal and pain in lower leg below knee added with lab results.Lab results performed on (b)(6) 2018 added.Concomitant medications of lorazepam (lorazepam); metformin (metformin); omeprazole (omeprazole); atenolol (atenolol); vitamin d nos (vitamin d nos); and hydrochlorothiazide (hydrochlorothiazide) added.Corrective treatment added; event details updated.To hospitalization for knee pain / pain is burning, sharp and stabbing / pain is sharp and located in the medial knee.Clinical course updated.Text amended accordingly.Follow up information was received on (b)(6) 2018.No new information was received.Additional information received on (b)(6) 2018 from lawyer.Case classification updated to legal.Suspect product lot number updated.Event of device malfunction added.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2019 from consumer.Medical history and concomitant medications were updated.Events of numbness, weakness and burning on lateral aspect of both lower legs, could not walk or stand, knees get red, cold, creatinine low, ast low and rdw increased were added with details.Outcome of event pain in lower leg below knee to pain in lower leg below knee/positive for extremity pain was updated to not recovered and joint range of motion decreased was updated to recovered.Symptoms for event of pseudo septic reaction were added.Clinical course updated.Text amended accordingly.
|
