| Lot Number DRSL001 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthralgia (2355); Swelling/ Edema (4577); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 03/30/2023 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated (b)(6) 2023: this case involves 71 years old male patient who had swelling down legs , trouble wb(weight bearing) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate.Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
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Event Description
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Swelling down legs / scales(right knee) [swelling of legs].Trouble wb(right knee) [weight bearing difficulty] ([condition aggravated]).Swelling (right knee) [injection site joint swelling] ([condition aggravated]).Redness(right knee) [injection site joint erythema] ([condition aggravated]).Increased pain(right knee) [injection site joint pain] ([condition aggravated]).Arthrocentesis, major(right knee) [arthrocentesis].Stomach ache [stomach ache].Nausea [nausea].Lack of efficacy [device ineffective].Case narrative: initial information received from united states on (b)(6) 2023 regarding an unsolicited valid serious case received from a non-healthcare professional
this case is linked to case 2023sa153611 (multiple devices suspect for same patient)
this case involves a 71 years old male patient who had swelling down legs , trouble wb(weight bearing), swelling, redness(right knee), increased pain(right knee), arthrocentesis, major(right knee), stomach ache, nausea and lack of efficacy while being treated with with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included: patient medical history: he had had knee pain for years increased with weightbearing activities such as walking.He had recurring swelling, he had had physical therapy and taken anti-inflammatories.He completed a series of synvisc injections in 2019 that helped.Most recent steroid injection in april helped for a couple of months.He had had increased symptoms since he fell fishing first week of july.He had chronic low back pain and was currently under evaluation in hot springs.He was under consideration for surgery but was unable to proceed due to his cardiac condition.He apparently had been diagnosed with peripheral neuropathy.He apparently had some cardiac disease and had had scent and balloon; he was on blood thinners.He had been followed for bilateral cmc (carpometacarpal)osteoarthritis and bilateral ankle pain as well.He reports ankles have been quite symptomatic over the past few weeks since his fall.X-rays of the right knee kl grade 4 medial narrowing, left knee kl grade 3+ narrowing
physical exam: mood and affect are normal
gait was mildly antalgic.Exam of the right knee shows no effusion.He had medial joint line tenderness.Clinical varus alignment that was not fully correctable, he had motion from 0-135 with pain at the limits actively and passively, lachman and mcmurray are negative.He had fair strength with resisted hip flexion and straight leg raise.Sensation was intact to light touch the skin was warm and dry the pedal pulses are palpable.Exam the left knee shows no effusion.Clinical varus alignment.Range of motion 0-1 35.Exam of the hand shows bilateral enlargement of the first cmc joint with tenderness to palpation.He had painful grind maneuver.Able to oppose the tip of the thumb to the base of the fifth.Exam of the ankle shows no swelling.He had anterior joint line tenderness bilaterally.Dorsiflexion 20 plantarflexion 35.Pain at the limits of motion.No crepitation.Diagnosis: anesthesia complication, anxiety, back pain, bph (benign prostatic hypertrophy),gerd (gastroesophageal reflux disease), post-operative nausea and vomiting
past surgical history: circumcision, finger surgery right, inner ear surgery bilateral, knee surgery right, tobacco use; smoking status: (former packs/day: 1,00 years: 5.00 pack years: 5.00 types; cigarettes quit date: 1/1/1980 years since quitting: 43.2); smokeless tobacco: current types: chew; vaping use: never used; alcohol use: yes (comment: occasional)
patient had ongoing allergies: suprenex [buprenorphine hcl], ibuprofen, mirabegron, cephalexin, clindamycin, doxycycline, gabapentin, hydrocortisone, macrolide antibiotics, oxycodone-acetaminophen, sulfamethoxazole-trimethoprim, tramadol, ciprofloxacin, codeine, and penicillins
concomitant medications included alprazolam (xanax); azelastine hydrochloride (astelin [azelastine hydrochloride]); baclofen (lioresal); buprenorphine (buprenorphine); celecoxib (celecoxib); cephalexin [cefalexin] (cephalexin [cefalexin]); ciprofloxacin hcl (ciprofloxacin hcl); clotrimazole (clotrimazole); dexamethasone (decadron [dexamethasone]); diclofenac (voltaren [diclofenac]); dicycloverine hydrochloride (bentyl); doxazosin mesilate (cardura); influenza vaccine inact split 4v (fluzone quadrivalent); fluconazole (fluconazole); fluticasone propionate (fluticasone propionate); gemfibrozil (lopid); ibuprofen (advil [ibuprofen]); ibuprofen (motrin [ibuprofen]); ketorolac tromethamine (toradol) for pain; levothyroxine sodium (synthroid); levothyroxine sodium (levothroid); meloxicam (moricam); metronidazole (flagyl [metronidazole]); nystatin (nystatin); omeprazole (prilosec [omeprazole]); oxycodone hydrochloride, paracetamol (percocet [oxycodone hydrochloride;paracetamol]); pneumococcal vaccine conj 13v (crm197) (prevnar 13); pregabalin (lyrica); pseudoephedrine hydrochloride (sudafed [pseudoephedrine hydrochloride]) for nasal congestion; sucralfate (carafate); tamsulosin hydrochloride (flomax [tamsulosin hydrochloride]); clopidogrel bisulfate (plavix); and asa (asa).On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee at a dose of 48 mg 1x (once) via intra-articular (lot - drsl001, expiry date: october 2025) for osteoarthritis.(unknown strength)(site of injection: anterior lateral)
on (b)(6) 2023, latency: same day, patient had arthrocentesis, major (right knee) (aspiration joint) performed
on (b)(6) 2023; latency: 1 day patient was having issues with his knees post injections.He thinks he was having a reaction: increase in swelling knees and calves (injection site joint swelling) (condition aggravated), cramping legs to toes bilateral , redness (injection site joint erythema) (condition aggravated), increased pain(right knee) (injection site joint pain) (condition aggravated )and lack of efficacy (device ineffective) per pt(patient) he doesn't drink enough water ,so will increase and tried pickle just and seems to help some, low on potassium, ice & elevation more , just started this last night, pt was on plavix and asa(acetylsalicylic acid) 81 mg, heart stent earlier this year, had meloxicam that he knows he can tolerate.Taking tylenol.Dr wanted to try a medrol dose pack, but pt was currently on prednisone 5 mg every other day for his legs swelling (peripheral swelling); due to complications of being on doxycycline.Recommended ice on a regular schedule and elevation of knees higher than the level of his heart.No chest pains or trouble breathing but states he's in severe pain with wb (weight bearing difficulty) (condition aggravated) and very limited in the flexion of the left knee feels tightness and pulling down into calf.Pt told her the swelling was a little better this morning and no calf pain.On an unknown date in (b)(6) 2023; pt was prescribed celebrex and he states that last night he woke up to nausea and severe stomachache (abdominal pain upper) (unknown latency).Advised celebrex 200 mg helped for three days: stomach cramping.Pt spoke with pharm, and now would like to try the 100 mg dose 1 x a day
action taken: not applicable for all events:
the patient was treated with prednisone (deltasone [prednisone]) for peripheral swelling and celecoxib (celebrex) for nausea and abdominal pain upper, ice pack or injection site joint swelling and not reported for rest events
at time of reporting, the outcome was recovering for the event injection site joint swelling , and was unknown for rest events.Seriousness criteria: all events assessed as medically significant and was leading to disability as per hcp(health care professional) except nausea, vomiting ,device ineffective and intervention required for arthrocentesis.
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Event Description
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Swelling down legs / scales(right knee) [swelling of legs] trouble wb(right knee) [weight bearing difficulty] ([condition aggravated]) swelling (right knee) [injection site joint swelling] ([condition aggravated]) redness(right knee) [injection site joint erythema] ([condition aggravated]) increased pain(right knee) [injection site joint pain] ([condition aggravated]) arthrocentesis, major (right knee) [arthrocentesis] stomach ache [stomach ache] nausea [nausea] lack of efficacy [device ineffective].Case narrative: initial information received from united states on 23-jun-2023 regarding an unsolicited valid serious case received from a non-healthcare professional this case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 71 years old male patient who had swelling down legs , trouble wb(weight bearing), swelling, redness(right knee), increased pain(right knee), arthrocentesis, major(right knee), stomach ache, nausea and lack of efficacy while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included: patient medical history: he had knee pain for years increased with weightbearing activities such as walking.He had recurring swelling, he had physical therapy and taken anti-inflammatories.He completed a series of synvisc injections in 2019 that helped.Most recent steroid injection in (b)(6) helped for a couple of months.He had increased symptoms since he fell fishing first week of (b)(6).He had chronic low back pain and was currently under evaluation in (b)(6).He was under consideration for surgery but was unable to proceed due to his cardiac condition.He apparently had been diagnosed with peripheral neuropathy.He apparently had some cardiac disease and had scent and balloon; he was on blood thinners.He had been followed for bilateral cmc (carpometacarpal)osteoarthritis and bilateral ankle pain as well.He reports ankles have been quite symptomatic over the past few weeks since his fall.X-rays of the right knee kl grade 4 medial narrowing, left knee kl grade 3+ narrowing physical exam: mood and affect are normal gait was mildly antalgic.Exam of the right knee shows no effusion.He had medial joint line tenderness.Clinical varus alignment that was not fully correctable, he had motion from 0-135 with pain at the limits actively and passively, lachman and mcmurray are negative.He had fair strength with resisted hip flexion and straight leg raise.Sensation was intact to light touch the skin was warm and dry the pedal pulses are palpable.Exam the left knee shows no effusion.Clinical varus alignment.Range of motion 0-1 35.Exam of the hand shows bilateral enlargement of the first cmc joint with tenderness to palpation.He had painful grind maneuver.Able to oppose the tip of the thumb to the base of the fifth.Exam of the ankle shows no swelling.He had anterior joint line tenderness bilaterally.Dorsiflexion 20 plantarflexion 35.Pain at the limits of motion.No crepitation.Diagnosis: anesthesia complication, anxiety, back pain, bph (benign prostatic hypertrophy),gerd (gastroesophageal reflux disease), post-operative nausea and vomiting past surgical history: circumcision, finger surgery right, inner ear surgery bilateral, knee surgery right, tobacco use; smoking status: (former packs/day: 1,00 years: 5.00 pack years: 5.00 types; cigarettes quit date: (b)(6) 1980 years since quitting: 43.2); smokeless tobacco: current types: chew; vaping use: never used; alcohol use: yes (comment: occasional).Patient had ongoing allergies: suprenex [buprenorphine hcl], ibuprofen, mirabegron, cephalexin, clindamycin, doxycycline, gabapentin, hydrocortisone, macrolide antibiotics, oxycodone-acetaminophen, sulfamethoxazole-trimethoprim, tramadol, ciprofloxacin, codeine, and penicillins concomitant medications included alprazolam (xanax); azelastine hydrochloride (astelin [azelastine hydrochloride]); baclofen (lioresal); buprenorphine (buprenorphine); celecoxib (celecoxib); cephalexin [cefalexin] (cephalexin [cefalexin]); ciprofloxacin hcl (ciprofloxacin hcl); clotrimazole (clotrimazole); dexamethasone (decadron [dexamethasone]); diclofenac (voltaren [diclofenac]); dicycloverine hydrochloride (bentyl); doxazosin mesilate (cardura); influenza vaccine inact split 4v (fluzone quadrivalent); fluconazole (fluconazole); fluticasone propionate (fluticasone propionate); gemfibrozil (lopid); ibuprofen (advil [ibuprofen]); ibuprofen (motrin [ibuprofen]); ketorolac tromethamine (toradol) for pain; levothyroxine sodium (synthroid); levothyroxine sodium (levothroid); meloxicam (moricam); metronidazole (flagyl [metronidazole]); nystatin (nystatin); omeprazole (prilosec [omeprazole]); oxycodone hydrochloride, paracetamol (percocet [oxycodone hydrochloride;paracetamol]); pneumococcal vaccine conj 13v (crm197) (prevnar 13); pregabalin (lyrica); pseudoephedrine hydrochloride (sudafed [pseudoephedrine hydrochloride]) for nasal congestion; sucralfate (carafate); tamsulosin hydrochloride (flomax [tamsulosin hydrochloride]); clopidogrel bisulfate (plavix); and asa (asa).On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee at a dose of 48 mg 1x (once) via intra-articular (lot - drsl001, expiry date: october 2025) for osteoarthritis.(unknown strength)(site of injection: anterior lateral).On (b)(6) 2023, latency: same day, patient had arthrocentesis, major (right knee) (aspiration joint) performed.On (b)(6) 2023; latency: 1 day patient was having issues with his knees post injections.He thinks he was having a reaction: increase in swelling knees and calves (injection site joint swelling) (condition aggravated), cramping legs to toes bilateral , redness (injection site joint erythema) (condition aggravated), increased pain(right knee) (injection site joint pain) (condition aggravated )and lack of efficacy (device ineffective) per pt(patient) he doesn't drink enough water ,so will increase and tried pickle just and seems to help some, low on potassium, ice & elevation more , just started this last night, pt was on plavix and asa(acetylsalicylic acid) 81 mg, heart stent earlier this year, had meloxicam that he knows he can tolerate.Taking tylenol.Dr wanted to try a medrol dose pack, but pt was currently on prednisone 5 mg every other day for his legs swelling (peripheral swelling); due to complications of being on doxycycline.Recommended ice on a regular schedule and elevation of knees higher than the level of his heart.No chest pains or trouble breathing but states he's in severe pain with wb (weight bearing difficulty) (condition aggravated) and very limited in the flexion of the left knee feels tightness and pulling down into calf.Pt told her the swelling was a little better this morning and no calf pain.On an unknown date in (b)(6) 2023; pt was prescribed celebrex and he states that last night he woke up to nausea and severe stomachache (abdominal pain upper) (unknown latency).Advised celebrex 200 mg helped for three days: stomach cramping.Pt spoke with pharm, and now would like to try the 100 mg dose 1 x a day.Action taken: not applicable for all events.The patient was treated with prednisone (deltasone [prednisone]) for peripheral swelling and celecoxib (celebrex) for nausea and abdominal pain upper, ice pack or injection site joint swelling and not reported for rest events.At time of reporting, the outcome was recovering for the event injection site joint swelling , and was unknown for rest events.Seriousness criteria: all events assessed as medically significant and was leading to disability as per hcp(health care professional) except nausea, vomiting, device ineffective and intervention required for arthrocentesis.Upon internal review on 30-jun-2023, the case with id: (b)(4) was identified to be duplicate of (b)(4).Hence, all the information from the case (b)(4) (case to be deleted) has been merged in case (b)(4) and current case (b)(4) has been prepared for deletion.
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Manufacturer Narrative
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Sanofi company comment dated 30-jun-2023: this case involves 71 years old male patient who had swelling down legs , trouble wb(weight bearing) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate.Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
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Search Alerts/Recalls
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