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This unsolicited case from united states was received on 26-mar-2018 from consumer.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown few hours patient limped off the table, some pain in her left knee/pain got worse during that afternoon and night, some swelling/more swelling on her left knee the next day/left knee swollen upto twice size, knee was hot to touch.Also, device malfunction was identified for the reported lot number.No past drugs and concomitant medication was provided.Patient had a history of diabetes mellitus type i and osteoarthritis.On an unknown date in 2017 ((b)(6) 2017 or (b)(6) 2017, she did not know the exact date she had the injection), the patient initiated treatment with intra-articular synvisc one injection once in left knee at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown).On an unknown date in 2017, few hours after receiving synvisc one, the patient limped off the table and did experiences some pain in her left knee.She said when she got home she her pain got worse during that afternoon and night.She said she was experiencing some swelling that same night but there was more swelling in her left knee the next day.She said the knee was hot to the touch and swollen.It was further reported that her left knee swollen up twice size mainly inner side of her left knee.Patient was able to bear weight before and after injection.She said the physician told her to stay off the knee for a couple of days.She said she had a crutch to help walk around at home.She said she called the physician's office the next day and talked to the nurse.She said the nurse told her that was normal to have pain after the injection and told her to start taking ibuprofen for the pain.She said the pain increased and so did the swelling.She said she had to go to physician therapy for two months and was given ice and electrical stimulation to her left knee.She said as of today, the knees still had some pain but not as much and the knee would get inflamed some if she did not exercise the knee and walk.She said she does knee stretches to help with the knee pain and swelling.She said she is still recovering but she still has some pain.Corrective treatment: crutches, electro therapy, physiotherapy, knee stretches for limped off the table; ibuprofen for some pain in her left knee/pain got worse during that afternoon and night; ice for some swelling/more swelling on her left knee the next day/left knee swollen upto twice size and knee was hot to touch outcome: not recovered for limped off the table, device malfunction; recovering for rest of the events 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.Seriousness criteria: disability for limped off the table; important medical event for device malfunction.Additional information was received on 29-mar-2018.Global ptc number was added.Text amended accordingly.Pharmacovigilance comment: sanofi follow-up company comment dated 29-mar-2018.The follow-up information received does not alter the overall case assessment.This case concerns a patient who received treatment with synvisc one from the recall lot and later experienced pain, swelling, joint warmth and difficulty in walking for which patient had to use crutches.Since event occurred on the day of administration of synvisc one injection, significant temporal relationship can be established and causal role of suspect product cannot be denied in occurrence of the events.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the product to the events cannot be excluded.
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Limped off the table/cadence increased [walking difficulty].Device malfunction [device malfunction].Continued fevers [fever].Fatigue/weakness [fatigue].Muscle weakness (generalized) [muscle weakness].Fatigue/weakness [weakness].Range of motion decreased [joint range of motion decreased].Some pain in her left knee/pain got worse during that afternoon and night [knee pain].Some swelling/more swelling on her left knee the next day/left knee swollen upto twice size [swelling of l knee].Knee was hot to touch [joint warmth].Burning sensation in her right knee/severe pain [burning sensation in joints].Swelling in right knee [knee swelling].Stiffness of left knee [stiff knees].Generalized joint effusion [joint effusion].Case narrative: this unsolicited legal case from united states was received on (b)(6) 2018 from the consumer.This case concerns a 50 year old female patient who received treatment with synvisc one and later after unknown few hours patient limped off the table, some pain in her left knee/pain got worse during that afternoon and night, some swelling/more swelling on her left knee the next day/left knee swollen upto twice size, knee was hot to touch.It was also reported that the patient experienced severe pain, swelling and burning sensation in her right knee coupled with continuous fevers, range of motion decreased, fatigue/weakness, muscle weakness (generalized), anterior glide tibia on femur left painful, generalized joint effusion, stiffness of left knee, difficulty with functional tasks to do household chores and to cook and squatting after the injection.Also, device malfunction was identified for the reported lot number.No past drugs and concomitant medication was provided.Patient had a history of diabetes mellitus type i, bilateral knee pain, osteoarthritis, inability to walk any prolonged distance, chronic low back pain, obesity and joint swelling.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once in left knee at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown).On an unknown date in 2017, few hours after receiving synvisc one, the patient limped off the table and did experiences some pain in her left knee.She said when she got home she her pain got worse during that afternoon and night.She said she was experiencing some swelling that same night but there was more swelling in her left knee the next day.She said the knee was hot to the touch and swollen.It was further reported that her left knee swollen up twice size mainly inner side of her left knee.On (b)(6) 2017, patient had large joint arthrocentesis.On (b)(2017, patient was reported to have pain in left knee, generalized muscle weakness, anterior glide tibia on femur left painful and stiffness of left knee (latency: unknown).Patient was advised rehabilitation therapy for 2 weeks.On (b)(6) 2017, patient was reported to have mild fatigue and weakness (latency: unknown) and to have progression under current plan.On (b)(6) 2017, patient had fatigue/weakness soreness.On (b)(6) 2017, patient reported to have decreased pain levels and increased le strength and range of motion, however she continued to have difficulty with functional tasks such as walking longer distances, standing longer periods, to do household chores and to cook and squatting.It was also reported that after the injection, patient experienced severe pain, swelling, burning sensations in her right knee along with continued fevers.On (b)(6) 2018, swelling and joint effusion was observed (latency: unknown).On (b)(6) 2018, patent was discharged with completion of rehabilitation program.Patient was able to bear weight before and after injection.She said the physician told her to stay off the knee for a couple of days.She said she had a crutch to help walk around at home.She said she called the physician's office the next day and talked to the nurse.She said the nurse told her that was normal to have pain after the injection and told her to start taking ibuprofen for the pain.She said the pain increased and so did the swelling.She said she had to go to physician therapy for two months and was given ice and electrical stimulation to her left knee.She said as of today, the knees still had some pain but not as much and the knee would get inflamed some if she did not exercise the knee and walk.She said she does knee stretches to help with the knee pain and swelling.She said she is still recovering but she still has some pain.It was reported that that due to all these events patient had to undergo two months of rehabilitation.Corrective treatment: crutches, electro therapy, physiotherapy, knee stretches for limped off the table; ibuprofen for some pain in her left knee/pain got worse during that afternoon and night; ice for some swelling/more swelling on her left knee the next day/left knee swollen upto twice size and knee was hot to touch, rehabilitation therapy for range of motion decreased, fatigue/weakness, difficulty with functional tasks to do household chores and to cook and squatting , muscle weakness (generalized), anterior glide tibia on femur left painful, generalized joint effusion, stiffness of left knee, some pain in her left knee/pain got worse during that afternoon and night outcome: not recovered for limped off the table, device malfunction; recovering for range of motion decreased, muscle weakness (generalized), some pain in her left knee/pain got worse during that afternoon and night, some swelling/more swelling on her left knee the next day/left knee swollen upto twice size knee was hot to touch; unknown for rest of the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 53297.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.Seriousness criteria: disability for limped off the table; important medical event for device malfunction.Additional information was received on (b)(6) 2018.Global ptc number was added.Text amended accordingly.Follow up information received on (b)(6) 2018.No new information was received.Additional information was received on (b)(6) 2018 from the legal specialist.Additional events of severe pain, swelling, burning sensation in right knee and continued fevers were added.Clinical course updated and text amended accordingly.Additional information was received on (b)(6) 2018 from the legal specialist.Events of range of motion decreased, fatigue/weakness, difficulty with functional tasks to do household chores and to cook and squatting , muscle weakness (generalized), anterior glide tibia on femur left painful, generalized joint effusion, stiffness of left knee were added with details.Corrective treatment for some pain in her left knee/pain got worse during that afternoon and night updated.Medical history updated.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2018 from lawyer.Lab test added.Medical history added.Clinical course updated and text amended accordingly.
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