| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Rash (2033); Arthralgia (2355); Joint Swelling (2356); Weight Changes (2607); No Code Available (3191)
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Event Type
Injury
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Event Description
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Knee locked in extension [joint lock].Knee injury difficulty doing usual, housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor, [activities of daily living impaired].Difficulty in walking/difficulty ambulating prolonged periods of time/ instability and abnormal gait/ antalgic gait with ascending and descending 3 flights of stairs [difficulty in walking].Left knee swelling [swelling of l knee].Left knee pain/ pain along knee complex/ dull ache/tenderness to palpation along anterior medial joint line, popliteal region [aching (l) knee] ([pain aggravated], [condition aggravated]).Knee injury [knee injury].Muscle weakness generalised/ weakness along lower extremity [generalized muscle weakness].Weakness [weakness].Difficulty in standing/ difficulty kneeling [difficulty in standing].Limited flexibility along lle/limited rom, without full extension during ambulation [joint range of motion decreased].Post operative swelling left knee [post procedural swelling].Impaired balance [balance impaired nos].Irritation to skin following treatment of e-stim [skin irritation].Anemia [anemia].Hernia [hernia].Infectious disease [infection].Dizziness or fainting [dizziness].Weight loss [weight loss].Sleeping problems/sleep difficult [sleep difficult].Tingling [tingling].Numbness [numbness].Occasional knee buckling [joint instability].Difficulty with weight bearing tolerance [weight bearing difficulty].Swelling on left lower extremity with prolonged walking and standing activities [peripheral swelling].Stiffness of left knee [stiff knees].Joint effusion left knee [joint effusion].Arthritis [arthritis] ([swollen joint]).Left knee rash [localized rash].Allergies [allergy].Case narrative: initial information received on 15-may-2020 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) year old male patient ((b)(6) kg) who experienced arthritis, knee injury, knee injury difficulty doing usual housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor, left knee pain/ pain along knee complex/ dull ache/tenderness to palpation along anterior medial joint line, popliteal region, stiffness of left knee, difficulty in walking/difficulty ambulating prolonged periods of time/ instability and abnormal gait/ antalgic gait with ascending and descending 3 flights of stairs, muscle weakness generalized/ weakness along lower extremity, weakness, difficulty in standing/ difficulty kneeling, limited flexibility along lle/limited rom, without full extension during ambulation, post operative swelling left knee, impaired balance, irritation to skin following treatment of e-stim, swelling on left lower extremity with prolonged walking and standing activities, knee locked in extension, left knee rash, left knee swelling, anemia, hernia, infectious disease, dizziness or fainting, weight loss, sleeping problems/sleep difficult, allergies, tingling, numbness, difficulty with weight bearing tolerance, joint effusion left knee and occasional knee buckling, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included asa; oxycodone for pain; duloxetine; vitamin d; and tramadol.On an unknown date, the patient took hylan g-f 20, sodium hyaluronate, (formulation, dosage, route, batch number unknown) for primary osteoarthritis left knee.On an unknown date, for several years, the patient had left knee pain.For knee pain conservative treatment including activity modification, therapy, nsaids and injection over 6 months but failed and then patient had total knee arthroplasty of left knee (tka) for it on (b)(6) 2017 (seriousness criteria: intervention required).The procedure was carried, and the patient was stabilized.Post surgically, there was difficulty in standing, ambulating prolonged periods of time secondary to weakness and pain along knee complex.The patient was able to ambulate at function distance in the past.The pain was dull and aggravated in the morning, standing and alleviated on rest.On (b)(6) 2017, the radiograph revealed no mechanical failure, fracture, loosening.Patient on (b)(6) 2017, latency unknown, at encounter for orthopedic care, the patient had muscle weakness (generalized), pain in the knee, weakness, limited rom, swelling, and difficulty walking.The patient also reported symptoms of pain with squatting, kneeling.Examination revealed large deficits in arom in both planes, postoperative swelling, weakness, instability, and abnormality of gait.The patient also showed impaired balance and limited tolerated to standing activity in general.After tka, the patient had difficulty doing usual work, housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor and was advised for skilled pt.On (b)(6) 2017, the patient presented with slight antalgic gait without full extension during ambulation and use of spc.Patient is slightly tender to palpation around the popliteal region and therapeutic exercise performed for the benefit of strength, endurance, and mobility.On (b)(6) 2017, it was noted that pain was only during the activity and there was improved ambulation.On (b)(6) 2017, presented with slight antalgic gait and lack of full extension during ambulation and patient demonstrated adequate strength.In the following visits, there had been improved strength and balance but still lacked full active range of motion.On (b)(6) 2017, there was 3-4/10 left knee pain, stiffness, and swelling, with ascending and descending 3 flights of stairs due to increased pain and swelling on left knee.On (b)(6) 2017, the patient reported increased swelling on left lower extremity with prolonged walking and standing activities.On (b)(6) 2017, there was continued improvement in symptoms and function.On an unknown date in (b)(6) 2018, the left knee had rash, swelling and there was difficulty walking, standing and to walk without a cane.On (b)(6) 2019, there was suspicion of infected tka but post- op diagnosis was no infection.Before the surgery, the knee was weight bearing but locked in extension.The patient was again put on therapy.Ambulating with sp cane and struggles to ambulate prolonged periods of time secondary to lack of endurance.Functionally patient was having difficulty with prolonged standing, weight bearing tolerance, negotiating stairs, engaging in regular exercise routine, and household / work related activities mainly due to pain, weakness, and limited mobility.Based on pt evaluation, patient presented with post-op orthopedic impairments consisting of decreased l knee arom, strength, proprioception/balance, and moderate ttp to anterior knee as well as popliteal region.On (b)(6) 2019, the patient was walking without a brace after therapy but continued to report stiffness and weakness along lower extremity.On (b)(6) 2019, there was 4/10 pain along knee and difficulty with lifting activities.On (b)(6) 2019, there was continued improvement in symptoms and function at the last visit.On an unknown date, the patient had arthritis, knee injury, hernia, anemia, infectious disease, dizziness or fainting, weight loss, sleep problems/difficult, tingling or numbness, allergies.Laboratory test results included: chest x-ray - on (b)(6) 2017: pre-op: no consolidation, pulmonary edema, pleural effusions computerised tomogram - on (b)(6) 2019: mild to moderate osteoarthritis with joint effusion.Action taken- unknown for all events.Corrective treatment: skilled pt, electrical stimulation/tens, therapeutic procedure, therapeutic exercise for difficulty in walking/difficulty ambulating prolonged periods of time/ instability and abnormal gait/ antalgic gait with ascending and descending 3 flights of stairs; activity modification, nsaids, therapy, injection over 6 months, knee arhroplasty, skilled pt, electrical stimulation/tens, therapeutic procedure, therapeutic exercise for left knee pain/ pain along knee complex/ dull ache/tenderness to palpation along anterior medial joint line, popliteal region; skilled pt, electrical stimulation/tens, therapeutic procedure, therapeutic exercise for impaired balance, knee swelling, difficulty in standing/ difficulty kneeling, muscle weakness generalised/ weakness along lower extremity, weakness, for limited flexibility along lle/limited rom, without full extension during ambulation, limited flexibility along lle/limited rom, without full extension during ambulation, difficulty in walking/difficulty ambulating prolonged periods of time/ instability and abnormal gait/ antalgic gait with ascending and descending 3 flights of stairs, stiffness of left knee.The patient outcome is reported as unknown for anemia, hernia, infectious disease, dizziness or fainting, weight loss, sleeping problems/sleep difficult, allergies, tingling, numbness, difficulty with weight bearing tolerance, joint effusion left knee, occasional knee buckling, post operative swelling left knee, arthritis knee injury, knee injury difficulty doing usual, housework, school activities,hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor, for swelling on left lower extremity with prolonged walking and standing activities, for knee locked in extension, for left knee rash; not recovered / not resolved for ascending and descending 3 flights of stairs due to increased pain and swelling on left knee; recovering / resolving for left knee swelling, irritation to skin following treatment of e-stim , impaired balance, difficulty in standing/ difficulty kneeling, muscle weakness generalised/ weakness along lower extremity, weakness, for limited flexibility along lle/limited rom, without full extension during ambulation, limited flexibility along lle/limited rom, without full extension during ambulation, difficulty in walking/difficulty ambulating prolonged periods of time/ instability and abnormal gait/ antalgic gait with ascending and descending 3 flights of stairs, stiffness of left knee, left knee pain/ pain along knee complex/ dull ache/tenderness to palpation along anterior medial joint line, popliteal region; not applicable for hernia.
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Event Description
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Knee locked in extension [joint lock].Knee injury, difficulty doing usual, housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor, [activities of daily living impaired].Difficulty in walking / difficulty ambulating prolonged periods of time / instability and abnormal gait / antalgic gait with ascending and descending 3 flights of stairs [difficulty in walking].Left knee swelling [swelling of l knee].Left knee pain / pain along knee complex / dull ache / tenderness to palpation along anterior medial joint line, popliteal region [aching (l) knee] ([pain aggravated], [condition aggravated]).Knee injury [knee injury].Muscle weakness generalised / weakness along lower extremity [generalized muscle weakness].Weakness [weakness].Difficulty in standing / difficulty kneeling [difficulty in standing].Limited flexibility along lle / limited rom, without full extension during ambulation [joint range of motion decreased].Post operative swelling left knee [post procedural swelling].Impaired balance [balance impaired nos].Irritation to skin following treatment of e-stim [skin irritation].Anemia [anemia].Hernia [hernia].Infectious disease [infection].Weight loss [weight loss].Sleeping problems/sleep difficult [sleep difficult].Numbness [numbness].Occasional knee buckling [joint instability].Difficulty with weight bearing tolerance [weight bearing difficulty].Dizziness or fainting [dizziness].Tingling [tingling].Swelling on left lower extremity with prolonged walking and standing activities [peripheral swelling].Stiffness of left knee [stiff knees].Joint effusion left knee [joint effusion].Arthritis [arthritis] ([swollen joint]).Left knee rash [localized rash].Allergies [allergy].Case narrative: upon review on 02-jun-2020, this case has been prepared for deletion as it was found to be duplicate of case: (b)(4).All information has been merged into case: (b)(4).Initial information received on 15-may-2020 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a 55 years old male patient (103.401 kg) who experienced arthritis, knee injury, knee injury difficulty doing usual, housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor, left knee pain / pain along knee complex / dull ache / tenderness to palpation along anterior medial joint line, popliteal region, stiffness of left knee, difficulty in walking / difficulty ambulating prolonged periods of time / instability and abnormal gait / antalgic gait with ascending and descending 3 flights of stairs, muscle weakness generalized / weakness along lower extremity, weakness, difficulty in standing / difficulty kneeling, limited flexibility along lle / limited rom, without full extension during ambulation, post operative swelling left knee, impaired balance, irritation to skin following treatment of e-stim, swelling on left lower extremity with prolonged walking and standing activities, knee locked in extension, left knee rash, left knee swelling, anemia, hernia, infectious disease, dizziness or fainting, weight loss, sleeping problems / sleep difficult, allergies, tingling, numbness, difficulty with weight bearing tolerance, joint effusion left knee and occasional knee buckling, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included asa; oxycodone for pain; duloxetine; vitamin d; and tramadol.On an unknown date, the patient took hylan g-f 20, sodium hyaluronate, (formulation, dosage, route, batch number unknown) for unilateral primary osteoarthritis, left knee.On an unknown date, for several years, the patient had left knee pain.For knee pain conservative treatment including activity modification, therapy, nsaids and injection over 6 months but failed and then patient had total knee arthroplasty of left knee (tka) for it on (b)(6) 2017 (seriousness criteria: intervention required).The procedure was carried, and the patient was stabilized.Post surgically, there was difficulty in standing, ambulating prolonged periods of time secondary to weakness and pain along knee complex.The patient was able to ambulate at function distance in the past.The pain was dull and aggravated in the morning, standing and alleviated on rest.On (b)(6) 2017, the radiograph revealed no mechanical failure, fracture, loosening.Patient on (b)(6) 2017, latency unknown, at encounter for orthopedic care, the patient had muscle weakness (generalized), pain in the knee, weakness, limited rom, swelling (event assessed as serious due to disability), and difficulty walking.The patient also reported symptoms of pain with squatting, kneeling.Examination revealed large deficits in arom in both planes, postoperative swelling, weakness, instability, and abnormality of gait.The patient also showed impaired balance and limited tolerated to standing activity in general.After tka, the patient had difficulty doing usual work, housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor and was advised for skilled pt.On (b)(6) 2017, the patient presented with slight antalgic gait without full extension during ambulation and use of spc.Patient is slightly tender to palpation around the popliteal region and therapeutic exercise performed for the benefit of strength, endurance, and mobility.On (b)(6) 2017, it was noted that pain was only during the activity and there was improved ambulation.On (b)(6) 2017, presented with slight antalgic gait and lack of full extension during ambulation and patient demonstrated adequate strength.In the following visits, there had been improved strength and balance but still lacked full active range of motion.On (b)(6) 2017, tjere was 3-4/10 left knee pain, stiffness, and swelling, with ascending and descending 3 flights of stairs due to increased pain and swelling on left knee.On (b)(6)2017, the patient reported increased swelling on left lower extremity with prolonged walking and standing activities.On (b)(6) 2017, there was continued improvement in symptoms and function.On an unknown date on (b)(6) 2018, the left knee had rash, swelling and there was difficulty walking, standing and to walk without a cane.On (b)(6)2019, there was suspicion of infected tka but post- op diagnosis was no infection.Before the surgery, the knee was weight bearing but locked in extension (event assessed as serious due to disability).The patient was again put on therapy.Ambulating with sp cane and struggles to ambulate prolonged periods of time secondary to lack of endurance.Functionally patient was having difficulty with prolonged standing, weight bearing tolerance, negotiating stairs, engaging in regular exercise routine, and household / work related activities (event assessed as serious due to disability) mainly due to pain, weakness, and limited mobility.Based on pt evaluation, patient presented with post-op orthopedic impairments consisting of decreased l knee arom, strength, proprioception / balance, and moderate ttp to anterior knee as well as popliteal region.On (b)(6) 2019, the patient was walking without a brace after therapy but continued to report stiffness and weakness along lower extremity.On (b)(6) 2019, there was 4/10 pain along knee and difficulty with lifting activities.On (b)(6) 2019, there was continued improvement in symptoms and function at the last visit.On an unknown date, the patient had arthritis, knee injury, hernia, anemia, infectious disease, dizziness or fainting, weight loss, sleep problems / difficult, tingling or numbness, allergies.Laboratory test results included: chest x-ray: on (b)(6) 2017: pre-op: no consolidation, pulmonary edema, pleural effusions computerised tomogram: on (b)(6) 2019: mild to moderate osteoarthritis with joint effusion.Action taken- unknown for all events.Corrective treatment: skilled pt, electrical stimulation / tens, therapeutic procedure, therapeutic exercise for difficulty in walking / difficulty ambulating prolonged periods of time / instability and abnormal gait / antalgic gait with ascending and descending 3 flights of stairs; activity modification, nsaids, therapy, injection over 6 months, knee arhroplasty, skilled pt, electrical stimulation / tens, therapeutic procedure, therapeutic exercise for left knee pain / pain along knee complex / dull ache / tenderness to palpation along anterior medial joint line, popliteal region; skilled pt, electrical stimulation / tens, therapeutic procedure, therapeutic exercise for impaired balance, knee swelling, difficulty in standing / difficulty kneeling, muscle weakness generalised / weakness along lower extremity, weakness, for limited flexibility along lle / limited rom, without full extension during ambulation, limited flexibility along lle / limited rom, without full extension during ambulation, difficulty in walking / difficulty ambulating prolonged periods of time / instability and abnormal gait / antalgic gait with ascending and descending 3 flights of stairs, stiffness of left knee.The patient outcome is reported as unknown for anemia, hernia, infectious disease, dizziness or fainting, weight loss, sleeping problems / sleep difficult, allergies, tingling, numbness, difficulty with weight bearing tolerance, joint effusion left knee, occasional knee buckling, post operative swelling left knee, arthritis knee injury, knee injury difficulty doing usual, housework, school activities, hobbies, recreational, sporting activities, getting out of bath, putting on shoes, squatting lifting an object from floor, for swelling on left lower extremity with prolonged walking and standing activities, for knee locked in extension, for left knee rash; not recovered / not resolved for ascending and descending 3 flights of stairs due to increased pain and swelling on left knee; recovering / resolving for left knee swelling, irritation to skin following treatment of e-stim , impaired balance, difficulty in standing / difficulty kneeling, muscle weakness generalised / weakness along lower extremity, weakness, for limited flexibility along lle / limited rom, without full extension during ambulation, limited flexibility along lle / limited rom, without full extension during ambulation, difficulty in walking / difficulty ambulating prolonged periods of time / instability and abnormal gait / antalgic gait with ascending and descending 3 flights of stairs, stiffness of left knee, left knee pain/ pain along knee complex / dull ache / tenderness to palpation along anterior medial joint line, popliteal region; not applicable for hernia.Upon review on 02-jun-2020 with clock start date on (b)(6) 2020, this case has been prepared for deletion as it was found to be duplicate of case: (b)(4).All information has been merged into case: (b)(4).
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