| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fever (1858); Chills (2191); Arthralgia (2355); Joint Swelling (2356); Joint Dislocation (2374); No Code Available (3191)
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| Event Date 01/24/2018 |
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Event Type
Injury
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Event Description
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Left knee arthroscopy [knee operation] ; cannot walk /difficulty in walking [unable to walk] ; feeling fever like symptoms [fever] ([chills]); hard time to put full weight on this leg [weight bearing difficulty] ; medical meniscus tear [meniscus tear of knee] ; internal derangement of left knee [internal derangement of knee] ; swelling [swelling of r knee] ; pain/throbbing [knee pain].Case narrative: this case was cross-referenced with case (b)(4) (same patient).Based on additional information received on (b)(6) 2018 by healthcare professional, the case has been medically confirmed.This unsolicited case from united states was received on (b)(6) 2018 from a non-healthcare professional.This case concerns a (b)(6) female patient who received treatment with synvisc one in her right knee and later after 1 day experienced hard time to put full weight on the leg, joint stiffness.After 6 days of receiving synvisc one, patient experienced internal derangement of left knee, medical meniscus tear left knee and underwent let knee arthroscopy for the same.After unknown latency patient experienced feeling fever like symptoms, cannot walk and had pain/throbbing and swelling.Patient reported surgical history of appendectomy, cholecystectomy, gallbladder surgery, hysterectomy, knee arthroscopy(therapeutic) and knee arthroscopy with debridement of articular cartilage, left knee scope (2010), right knee scope ((b)(6) 2016), epidural steroid injection right and left knee, achilles tendonitis ((b)(6) 2014) family history of cardiac disorder, diabetes mellitus, hyperlipidemia, hypertension and hypothyroidism (mother), cerebrovascular accident (uncle) and colon cancer (father).Patient is a nonsmoker and does not indulge in alcohol or drug use.Patient's medical history included high cholesterol, thyroid disorder.Concomitant medications reported were buspirone hydrochloride(buspar), celecoxib, hydrochlorothiazide, levothyroxine sodium, escitalopram oxalate(lexapro), chlordiazepoxide hydrochloride, clidinium bromide (librax) , meloxicam, metoprolol succinate, hydrocodone bitartrate, paracetamol (norco), pravastatin sodium (pravachol), codeine phosphate, tramadol hcl, paracetamol(tylenol w/codeine), tizanidine, boniva on (b)(6) 2018, the patient initiated treatment with intra-articular synvisc one injection (dose and frequency: unknown) into the right knee for osteoarthritis.On (b)(6) 2018, patient reported joint stiffness, numbness and weakness in feet, hard time to put full weight on leg, back pain.On an unknown date in (b)(6) 2018, later that day, she started to experience pain, swelling, and throbbing, chills and feeling fever like symptoms.The physician told her that she received the recalled lot.On an unknown date in (b)(6) 2018, patient could not walk.As on (b)(6) 2018, the patient was still experiencing the same symptoms, but now could not walk.It was reported that the patient was very upset with the situation.The physician instructed her to apply ice, and take a seven-day regimen of amoxicillin and paracetamol (tylenol).On (b)(6) 2018,on the same day the patient was admitted in the hospital for the arthroscopy of the left knee and partial medial menisectomy together with debridement of degenerative changes.She had symptoms with no known trauma and had an magnetic resonance imaging (mri) since the knee would locking and popping and it revealed primary osteoarthritis, but with the tear of the inferior articular surface of the posterior horn of the medial meniscus where she complained of pain and was positive for pain on internal and external rotation.Patient was cleared for surgery.On the same day, the blood pressure of the patient was 150/80(reference range and units: not reported), heart rate was 68 beats/minute (reference range: not reported), body mass index (bmi) was 50.68, indicated morbid obesity.It was reported that the patient had mild retropatellar crepitus but was tender over the medial joint line particularly with external and internal rotation.Chest x-ray was normal.On the same day, leukocyte esterase was present in traces, aspartate aminotransferase and alanine transaminase was raised, uric acid was raised to 6.8 (units, reference range: not reported).Action taken: unknown.Corrective treatment: not reported for cannot walk, joint stiffness, numbness and weakness in feet, hard time to put full weight on leg, back pain; amoxicillin for feeling fever like symptoms, ice, amoxicillin, paracetamol (tylenol) for pain/throbbing and swelling.Patient had to undergo left knee arthroscopy for internal derangement and medial meniscus tear.Outcome: unknown for all the events.A product technical complaint was initiated with gptc number (b)(4) and results for the same were received.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 14-mar-2018.Investigation summary results and gptc number were added.Clinical course was updated and text was amended accordingly.Additional information was received on (b)(6) 2018 from healthcare professional.Events of left knee arthroscopy, finding hard to put full weight on leg, internal derangement of left knee, medical meniscus tear left knee were added.Clinical course was updated and text was amended accordingly.Follow up information was received on 10-jun-2018.No new information was received.Upon internal review on (b)(6) 2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.
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Event Description
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Left knee arthroscopy [knee operation] cannot walk /difficulty in walking [unable to walk] feeling fever like symptoms [fever] ([chills]) hard time to put full weight on this leg [weight bearing difficulty] medical meniscus tear [meniscus tear of knee] internal derangement of left knee [internal derangement of knee] swelling [swelling of r knee] pain/throbbing [knee pain] case narrative: this case was cross-referenced with case (b)(4).Based on additional information received on 17-may-2018 by healthcare professional, the case has been medically confirmed.This unsolicited case from united states was received on 19-jan-2018 from a non-healthcare professional.This case concerns a 48-year-old female patient who received treatment with synvisc one in her right knee and later after 1 day experienced hard time to put full weight on the leg, joint stiffness.After 6 days of receiving synvisc one, patient experienced internal derangement of left knee, medical meniscus tear left knee and underwent let knee arthroscopy for the same.After unknown latency patient experienced feeling fever like symptoms, cannot walk and had pain throbbing and swelling.Patient reported surgical history of appendectomy, cholecystectomy, gallbladder surgery, hysterectomy, knee arthroscopy(therapeutic) and knee arthroscopy with debridement of articular cartilage, left knee scope (2010), right knee scope (b)(6) 2016, epidural steroid injection right and left knee, achilles tendonitis (b)(6) 2014 family history of cardiac disorder, diabetes mellitus, hyperlipidemia, hypertension and hypothyroidism (mother), cerebrovascular accident (uncle) and colon cancer (father).Patient is a nonsmoker and does not indulge in alcohol or drug use.Patient's medical history included high cholesterol, thyroid disorder.Concomitant medications reported were buspirone hydrochloride(buspar), celecoxib, hydrochlorothiazide, levothyroxine sodium, escitalopram oxalate(lexapro), chlordiazepoxide hydrochloride, clidinum bromide (librax) , meloxicam, metoprolol succinate, hydrocodone bitartrate, paracetamol (norco), pravastatin sodium (pravachol), codeine phosphate, tramadol hcl, paracetamol(tylenol w/codeine), tizanidine, boniva.On (b)(6)2018, the patient initiated treatment with intra-articular synvisc one injection (dose and frequency: unknown) into the right knee for osteoarthritis.On (b)(6) 2018, patient reported joint stiffness, numbness and weakness in feet, hard time to put full weight on leg, back pain.On an unknown date in (b)(6)2018, later that day, she started to experience pain, swelling, and throbbing, chills and feeling fever like symptoms.The physician told her that she received the recalled lot.On an unknown date in jan-2018, patient could not walk.As on (b)(6) 2018, the patient was still experiencing the same symptoms, but now could not walk.It was reported that the patient was very upset with the situation.The physician instructed her to apply ice, and take a seven-day regimen of amoxicillin and paracetamol (tylenol).On (b)(6)2018,on the same day the patient was admitted in the hospital for the arthroscopy of the left knee and partial medial menisctomy together with debridement of degenerative changes.She had symptoms with no known trauma and had an magnetic resonance imaging (mri) since the knee would locking and popping and it revealed primary osteoarthritis, but with the tear of the inferior articular surface of the posterior horn of the medial meniscus where she complained of pain and was positive for pain on internal and external rotation.Patient was cleared for surgery.On the same day, the blood pressure of the patient was 150/80(reference range and units: not reported), heart rate was 68 beats/minute (reference range: not reported), body mass index (bmi) was 50.68, indicated morbid obesity.It was reported that the patient had mild retropatellar crepitus but was tender over the medial joint line particularly with external and internal rotation.Chest x-ray was normal.On the same day, leukocyte esterase was present in traces, aspartate aminotransferase and alanine transaminase was raised, uric acid was raised to 6.8 (units, reference range: not reported).Action taken: unknown.Corrective treatment: not reported for cannot walk, joint stiffness, numbness and weakness in feet, hard time to put full weight on leg, back pain; amoxicillin for feeling fever like symptoms, ice, amoxicillin, paracetamol (tylenol) for pain/throbbing and swelling.Patient had to undergo left knee arthroscopy for internal derangement and medial meniscus tear.Outcome: unknown for all the events.A product technical complaint was initiated with gptc number (b)(4) and results for the same were received.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 14-mar-2018.Investigation summary results and gptc number were added.Clinical course was updated and text was amended accordingly.Additional information was received on 17-may-2018 from healthcare professional.Events of left knee arthroscopy, finding hard to put full weight on leg, internal derangement of left knee, medical meniscus tear left knee were added.Clinical course was updated and text was amended accordingly.Follow up information was received on 10-jun-2018.No new information was received.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.Upon internal review on 09-jan-2019 processed with clock start date of 17-may-2018 the malfunction field previously captured as yes was removed.
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Search Alerts/Recalls
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