MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number DRSL001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Myalgia (2238); Arthralgia (2355); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Injection Site Reaction (4562); Swelling/ Edema (4577); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2023

Event Type Injury

Event Description

Cannot stand for very long [difficulty in standing].Severe pain in their muscles [muscle pain].Knees swelled 4 times their size [injection site joint swelling].Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [arthralgia].Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [radiating pain].Part of the stomach when sitting down [stomach pain].Case narrative: initial information received from united states on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.Case is linked with (b)(6)(multiple devices suspect for same patient).This case involves a 71 years old male patient whose knees swelled 4 times their size, experienced severe pain in their muscles, pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down and cannot stand for very long, after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included he had trouble with their knees in the past and they get injections every week or 3 weeks.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection (right knee) (with unknow strength, dose, route, frequency, indication, batch number and expiry date).Information regarding the batch number and expiry date was requested.First time product used : yes.On (b)(6) 2022 next day (latency: 1 day) the patient's knees swelled 4 times their size (injection site joint swelling, disability), had severe pain in their muscles (myalgia; disability), pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down (arthralgia, disability) pain (disability) and (abdominal pain upper) and could not stand for very long (dysstasia, disability).It was reported that patient already put ice on them but that does not help.It was reported that this was first time this happened.It was reported that they already followed up with their prescribing physician who acknowledged that they have seen similar reaction only couple times in their career and is thinking that it may be that the patient could not handle the dose that was administered.They switched to another physician who recommended total knee replacement.They stated that adverse event knocked them down differently since they are on a wheel chair now.They also mentioned that they could not touch the back and sides of their knees which was also why the new physician was recommending replacement.Patient was informed of the common side effects, timing of resolution, and common treatments but referred them to their health care providers for further medical advice.It was also reported that the patient was still experiencing symptoms despite treatment.No further information was provided.Action taken: not applicable for all the events.Corrective treatment: using wheelchair for dysstasia, injection site joint swelling, pain, myalgia, arthralgia, ; ice for injection site joint swelling and myalgia and unspecified medication for rest of the events.Outcome: not recovered for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

(b)(4) company comment dated (b)(6) 2023: this case involves a patient whose knees swelled 4 times their size, experienced severe pain in their muscles, pain seemed to have traveled from their knees to their hip and cannot stand for very long, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.In addition medical history of unspecified disorder of knee joint could be confounding factor in this case.

Event Description

Adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long [difficulty in standing] severe pain in their muscles [muscle pain] knees swelled 4 times their size (right knee) [injection site joint swelling] pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [arthralgia] ([radiating pain]) had swelling in his ankle [joint swelling] pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [stomach pain] he apparently can not tolerate synvisc, causing an allergic reaction [allergic reaction] ([itchy skin], [skin burning sensation], [welts]) it has disturbed his sleep [sleep disturbance] trouble getting out of the bed [mobility decreased] sensitivity to clothes, including pants, socks, and boots [increased skin sensitivity] pain [pain] case narrative: initial information was received from united states on 15-may-2023 regarding an unsolicited valid serious case from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 70 years old male patient who adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long, severe pain in their muscles, knees swelled 4 times their size (right knee), pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down, had swelling in his ankle, pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down, he apparently can not tolerate synvisc, causing an allergic reaction, it has disturbed his sleep, trouble getting out of the bed, sensitivity to clothes, including pants, socks, and boots and pain, after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included he had trouble with their knees in the past and they get injections every week for 3 weeks.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection at dose of 1 injection in each knee (right knee) (strength: 16 mg/2ml) (with unknown dose, route, frequency, indication, batch number and expiry date).Information regarding the batch number and expiry date was requested.On (b)(6) 2022 next day (latency: 1 day) the patient's knees swelled 4 times their size (injection site joint swelling, caused disability), had severe pain in their muscles (myalgia, caused disability).It was reported that patient already put ice on them but that does not help.This was first time this happened.They already followed up with their prescribing physician who acknowledged that they have seen similar reaction only couple times in their career and was thinking that it might be that the patient could not handle the dose that was administered.They switched to another physician who recommended total knee replacement since the pain seemed to have traveled from their knees to their hip (arthralgia, pain, caused disability) and even part of the stomach when sitting down (abdominal pain upper) (onset: (b)(6) 2022, latency: 1 day).They stated that adverse event knocked them down differently since they were on a wheel chair now and cannot stand for very long (dysstasia, onset and latency: unknown, caused disability).They also mentioned that they could not touch the back and sides of their knees which was also why the new physician was recommending replacement.Patient was informed of the common side effects, timing of resolution, and common treatments but referred them to their health care providers for further medical advice.It was also reported that the patient was still experiencing symptoms despite treatment.No further information was provided.On an unknown date, after an unknown latency, patient had a "major reaction" after injection in both knees.He stated his knees were swollen 4 times the size they are normally.He had swelling in his ankle (joint swelling) (serious disability) and his "muscle is just recovering".He had to use a walker for ambulation.He said the nurse attributed the ankle swelling to standing.On an unknown date, after an unknown latency, patient had pain (pain) and sensitivity to clothes, including pants, socks, and boots (hyperaesthesia), has disturbed his sleep (sleep disorder) and he has trouble getting out of the bed (mobility decreased).He stated he apparently can not tolerate synvisc one, causing an allergic reaction (hypersensitivity) which makes his skin itch (pruiritis) and feel like it is "on fire" (skin burning sensation), and he has whelps on his skin (urticaria).Patient stated that he regrets getting the injections and it has been "hell".He has also been to a gi doctor for symptoms.On (b)(6) 2023, patient was scheduled for surgery and has had ct with another scan scheduled prior to surgery.It was also reported that patient was having knee replacement and he was hoping to get the synvisc one out of his knees.He was told he would have extensive hospital stay for monitoring post op and rehab.He was seeing hcp (health care professional) today.He was taking otc (over the counter) pain medications.Ptc assessment medical/physical : medical hcp can be contacted : yes.Relevant laboratory test results included: computerised tomogram - in 2023: [unknown results].Action taken: unknown for all the events.Corrective treatment: using wheelchair for dysstasia, joint swelling; ice for injection site joint swelling, arthralgia otc medication for pain and myalgia and not reported for rest of the events.Outcome: recovering / resolving for the event severe pain in their muscles, was not recovered / not resolved for the event knees swelled 4 times their size (right knee), pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down, knocked them down differently since they are on a wheel chair now and cannot stand for very long, was unknown for the event pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down, was unknown for the event had swelling in his ankle, was unknown for the event he apparently can not tolerate synvisc, causing an allergic reaction, was unknown for the event it has disturbed his sleep, was unknown for the event sensitivity to clothes, including pants, socks, and boots, was unknown for the event trouble getting out of the bed and was unknown for the event pain.A product technical complaint (ptc) was initiated on 15-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100327886.The sample status of the ptc was not available.Ptc stated: complaint: adverse event.Based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.(tj 17may2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective action and preventive action) was required.Ptc has been reopened the final investigation was completed on 30-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 15-may-2023 from other healthcare professional (from quality department).Product strength and ptc number was added.Upon internal review, action taken was updated to unknown from not applicable for all the events.Text amended accordingly.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly.Additional information was received on 31-may-2023 from the patient.New events: had swelling in his ankle, he apparently can not tolerate synvisc, causing an allergic reaction, it has disturbed his sleep, trouble getting out of the bed, sensitivity to clothes, including pants, socks, and boots and pain were added.Outcome for myalgia was updated.Text amended.

Event Description

Adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long [difficulty in standing].Trouble (wb) right knee [weight bearing difficulty] ([condition aggravated]).Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [pain in hip].Swelling down legs/ calves/increased in swelling knees and calves especially the left knee [peripheral swelling] ([condition aggravated]).Severe pain in their muscles [muscle pain].Increased redness (right knee) [injection site joint erythema].([condition aggravated]) had swelling in his ankle [ankle swelling].Knees swelled 4 times their size/increased swelling/lot of swelling (right knee) [injection site joint swelling] ([condition aggravated]).Increased pain/severe pain with weight bearing (right knee)/pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [injection site joint pain] ([condition aggravated], [radiating pain], [device ineffective]).Neurological: positive for weakness [weakness].It has disturbed his sleep [sleep disturbance].Pain and sensitivity to clothes, including pants, socks, and boots [pain].Sensitivity to clothes, including pants, socks, and boots [increased skin sensitivity].Trouble getting out of the bed [mobility decreased].Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/severe stomach ache/stomach cramping [stomach pain].Vomiting [vomiting].Cramping legs to toes [pain in extremity].Nausea [nausea].Musculoskeletal: positive for gait problem [gait disturbance].He apparently cannot tolerate synvisc one, causing an allergic reaction [allergic reaction] ([skin burning sensation], [welts], [itchy skin]).Case narrative: initial information was received from united states on 15-may-2023 regarding an unsolicited valid serious case from a patient.This case is linked to cases: (b)(6) (synvisc-one left knee) (multiple devices suspect for the same patient) and (b)(6) (duplicate case).This case involves a 71 years old male patient who had adverse event that knocked them down differently since they are on a wheel chair now and cannot stand for very long, trouble (wb-weight bearing) right knee, swelling down legs/ calves/increased in swelling knees and calves especially the left knee , severe pain in their muscles, increased redness (right knee), had swelling in his ankle, knees swelled 4 times their size/increased swelling/lot of swelling (right knee), increased pain (right knee), pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/severe stomach ache/stomach cramping, neurological: positive for weakness, it has disturbed his sleep, pain and sensitivity to clothes, including pants, socks, and boots, trouble getting out of the bed, nausea, musculoskeletal: positive for gait problem , cramping legs to toes bilateral and he apparently cannot tolerate synvisc one, causing an allergic reaction after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and celecoxib (celebrex).The patient's past medical history included he had trouble with their knees in the past and they get injections every week for 3 weeks.He had had knee pain for years increased with weightbearing activities such as walking.He had recurring swelling (knees).Had trouble bending knees.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-2022 helped for a couple of months.He had had increased symptoms since he fell fishing first week of july-2022.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), postoperative nausea and vomiting.Past surgical history: circumcision, finder surgery right, inner ear surgery bilateral, knee surgery right, arthrocentesis major.Tobacco use; smoking status: (former packs/day: 1,000 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.The patient's family history was not provided.Concomitant medications included alprazolam (xanax); azelastine hydrochloride (astelin); baclofen (lioresal); buprenorphine; cefalexin (keflex); ciprofloxacin hydrochloride; clotrimazole; dexamethasone (decadron); dicycloverine hydrochloride (bentyl); doxazosin mesilate (cardura); influenza vaccine inact split 4v (fluzone quadrivalent); fluconazole; fluticasone propionate; gemfibrozil (lopid); levothyroxine sodium (synthroid); levothyroxine sodium (levothroid); metronidazole (flagyl); nystatin; omeprazole (prilosec [omeprazole]); oxycodone hydrochloride, paracetamol (percocet); pneumococcal vaccine conj 13v (crm197) (prevnar 13); pregabalin (lyrica); pseudoephedrine hydrochloride (sudafed) for nasal congestion; sucralfate (carafate); tamsulosin hydrochloride (flomax relief); diclofenac (voltaren); ibuprofen (advil); ibuprofen (motrin); ketorolac (toradol) for pain; meloxicam (moricam); clopidogrel bisulfate (plavix); asa (acetylsalicylic acid) and meloxicam (mobic).Patient was on steroid dose pack (from (b)(6) 2023).On (b)(6) 2023, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection (liquid solution) at dose of 48 mg 1 injection (once) in right knee (intra-articular) (site of injection: anterior lateral knee) (strength: 48mg/6ml) (with batch number drsl001 and expiry date oct-2025) for primary localized osteoarthrosis of right lower leg/bilat knees oa (osteoarthritis).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) (peripheral swelling), cramping legs to toes bilateral (pain in extremity), redness (injection site joint erythema) (condition aggravated), increased pain (right knee) (injection site joint pain) (condition aggravated) and lack of efficacy (device ineffective).On (b)(6) 2023 next day (latency: 1 day) the patient's knees swelled 4 times their size they were normally (injection site joint swelling, caused disability), had severe pain in their muscles (myalgia, caused disability).It was reported that patient already put ice on them but that did not help.This was first time this happened.They already followed up with their prescribing physician who acknowledged that they have seen similar reaction only couple times in their career and was thinking that it might be that the patient could not handle the dose that was administered.They switched to another physician who recommended total knee replacement since the pain seemed to have traveled from their knees to their hip (arthralgia, pain, caused disability) and even part of the stomach when sitting down (abdominal pain upper) (onset: (b)(6) 2023, latency: 1 day).They stated that adverse event knocked them down differently since they were on a wheelchair now and cannot stand for very long (dysstasia, onset and latency: unknown, caused disability).They also mentioned that they could not touch the back and sides of their knees which was also why the new physician was recommending replacement.Patient was informed of the common side effects, timing of resolution, and common treatments but referred them to their health care providers for further medical advice.It was also reported that the patient was still experiencing symptoms despite treatment.On an unknown date, in 2023 after an unknown latency, patient had a "major reaction" after injection in both knees.He had swelling in his ankle (joint swelling) (serious disability) and his "muscle is just recovering".He had to use a walker for ambulation.He said the nurse attributed the ankle swelling to standing.On an unknown date, after an unknown latency, patient had pain (pain) and sensitivity to clothes, including pants, socks, and boots (hyperaesthesia), had disturbed his sleep (sleep disorder) and he had trouble getting out of the bed (mobility decreased).He stated he apparently cannot tolerate synvisc one, causing an allergic reaction (hypersensitivity) which makes his skin itch (pruritus) and feel like it is "on fire" (skin burning sensation), and he had whelps on his skin (urticaria).Patient stated that he regretted getting the injections and it had been "hell".It was reported on 03-apr-23, per pt(patient) he was not drinking enough water, so will increase and tried pickle just and seemed 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 (doctor) wanted to try a medrol dose pack, but patient was currently on prednisone 5 mg every other day for his legs 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 was 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.On (b)(6) 2023, patient told her the swelling was a little better this morning and no calf pain.Patient stated that swelling on his knee gone down a little.He called his pcp (primary care physician) and was advised to continued to follow up with doctor (surgery-orthopaedics).Review of systems on (b)(6) 2023, patient had neurological: positive for weakness.(asthenia); positive for gait problem (gait disturbance) (latency:14 days).In (b)(6) 2023 the patient was prescribed celebrex and he stated that last night ((b)(6) 2023) he woke up to nausea and severe stomachache (abdominal pain upper) (latency: 18 days).Advised celebrex 200 mg helped for three days and then developed nausea, vomiting (n/v) and stomach cramping.Patient spoke with pharm, and now would like to try the 100 mg dose 1 x a day, will take after breakfast.He had also been to a gi (gastrointestinal) doctor for symptoms.Patient will be seeing cardiologist on (b)(6) 2023.On (b)(6) 2023, patient was scheduled for surgery and had ct (computerized tomography) with another scan scheduled prior to surgery.It was also reported that patient was having knee replacement and he was hoping to get the synvisc one out of his knees.He was told he would have extensive hospital stay for monitoring post op and rehab.He was seeing hcp (health care professional) today ((b)(6) 2023).He was taking otc (over the counter) pain medications.Relevant laboratory test results included: computerised tomogram - in 2023: [unknown results] and on (b)(6) 2023 arthrocentesis major done.Action taken: not applicable for all the events with synvisc-one; dose reduced for nausea, abdominal pain and vomiting and unknown for rest of the events with celecoxib (celebrex).Corrective treatment: using wheelchair for dysstasia, joint swelling, prednisone (deltasone) for peripheral swelling; ice for injection site joint swelling, arthralgia; otc (over the counter) medication (unspecified) for pain and myalgia; ice pack or injection site joint swelling, celebrex (short course of anti-inflammatories), home range of motion and strengthening program for injection site joint pain and not reported for rest events.Outcome: not recovered for dysstasia, weight bearing difficulty, injection site joint erythema; recovering for myalgia, injection site joint pain, joint swelling, peripheral swelling, injection site joint swelling, arthralgia; unknown for rest of the events.Seriousness criteria: disability for dysstasia, myalgia, joint swelling, arthralgia; disability and medically significant for trouble (wb) right knee and peripheral swelling; injection site joint erythema, injection site joint swelling, injection site joint pain.A product technical complaint (ptc) was initiated on 15-may-2023 for synvisc one (lot/batch number: unknown) with global ptc number: 100327886.The sample status of the ptc was not available.Ptc stated: complaint: adverse event.Based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class had been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective action and preventive action) was required.The final investigation was completed on 11-jul-2023 with summarized conclusion as no assessment possible.Additional information was received on 15-may-2023 from other healthcare professional (from quality department).Product strength and ptc number was added.Upon internal review, action taken was updated to unknown from not applicable for all the events.Text amended accordingly.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly.Additional information was received on 31-may-2023 from the patient.New events: had swelling in his ankle, he apparently cannot tolerate synvisc, causing an allergic reaction, it has disturbed his sleep, trouble getting out of the bed, sensitivity to clothes, including pants, socks, and boots and pain were added.Outcome for myalgia was updated.Text amended.Upon internal review on 30-jun-2023, the case with id: (b)(6) was identified to be duplicate of (b)(6).Hence, all the information from the case (b)(6) (case to be deleted) has been merged in case (b)(6).Concomitant medications, medical history added, batch number, expiry date, dose, route of suspect added, suspect updated from synvisc to synvisc one, events added.Co-suspect celebrex added.Clinical course was updated and text amended accordingly.Additional information was received on 07-jul-2023 from other healthcare professional quality department.Ptc reopened information added.Text amended accordingly.Additional information was received on 11-jul-2023 from other healthcare professional via quality department.Product updated from synvisc to synvisc one in investigation summary.Final investigation date updated.Text amended accordingly.

Event Description

Massive blood clot [clot blood].Adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long [difficulty in standing].Trouble (wb) right knee [weight bearing difficulty] ([condition aggravated]).Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [pain in hip].Had swelling in his ankle//the medication was seeping out causing ankle swelling [ankle swelling].Severe pain in their muscles [muscle pain].Swelling down legs/ calves/increased in swelling knees and calves especially the left knee/swelling in his knees, ankles and feet/ the medication was seeping out causing foot swelling [peripheral swelling] ([condition aggravated]).Increased redness (right knee) [injection site joint erythema] ([condition aggravated]) knees swelled 4 times their size/increased swelling/lot of swelling (right knee).[injection site joint swelling] ([condition aggravated]).Increased pain/severe pain with weight bearing (right knee)/pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [injection site joint pain] ([condition aggravated], [radiating pain], [device ineffective]).Neurological: positive for weakness/no energy [weakness].It has disturbed his sleep [sleep disturbance].Pain and sensitivity to clothes, including pants, socks, and boots [pain of skin].Sensitivity to clothes, including pants, socks, and boots/continues to have sensitivity in his muscles which you "could not touch" [increased skin sensitivity].No cartilage after the shot [cartilage damage].Trouble getting out of the bed [mobility decreased].Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/severe stomach ache/stomach cramping [stomach pain].Vomiting [vomiting].Has muscular weakness in his legs [muscle weakness lower limb].Hypertension after the injections [hypertension].Sick for a month [sickness].Cramping legs to toes bilateral [muscle cramps].Nausea [nausea].Musculoskeletal: positive for gait problem/still can barely walk [gait disturbance].He apparently cannot tolerate synvisc one, causing an allergic reaction [allergic reaction] ([skin burning sensation], [welts], [itchy skin]).Case narrative: initial information was received from united states on 15-may-2023 regarding an unsolicited valid serious case from a patient.This case is linked to cases: (b)(4) (synvisc-one left knee) (multiple devices suspect for the same patient) and (b)(4) (duplicate case).This case involves a 71 years old male patient who experienced massive blood clot, adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long, trouble (wb-weight bearing) right knee, pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down, had swelling in his ankle/the medication was seeping out causing ankle swelling, swelling down legs/ calves/increased in swelling knees and calves especially the left knee/swelling in his knees, ankles and feet/ the medication was seeping out causing foot swelling, severe pain in their muscles, increased redness (right knee), knees swelled 4 times their size/increased swelling/lot of swelling (right knee), increased pain/severe pain with weight bearing (right knee)/pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/ severe stomach ache/stomach cramping, neurological: positive for weakness/no energy, it has disturbed his sleep, pain and sensitivity to clothes, including pants, socks, and boots/continues to have sensitivity in his muscles which you "could not touch", no cartilage after the shot, trouble getting out of the bed, vomiting, has muscular weakness in his legs, hypertension after the injections, sick for a month, cramping legs to toes bilateral, nausea, musculoskeletal: positive for gait problem/still can barely walk and he apparently cannot tolerate synvisc one, causing an allergic reaction after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and celecoxib (celebrex) the patient's past medical history included legs swelling due to complications of being on doxycycline, he had trouble with their knees in the past and they get injections every week for 3 weeks.He had had knee pain for years increased with weightbearing activities such as walking.He had recurring swelling (knees).Had trouble bending knees.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-2022 helped for a couple of months.He had had increased symptoms since he fell fishing first week of july-2022.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), postoperative nausea and vomiting.Past surgical history: circumcision, finger surgery right, inner ear surgery bilateral, arthrocentesis major.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.The patient's family history was not provided.Concomitant medications included alprazolam (xanax); azelastine hydrochloride (astelin); baclofen (lioresal); buprenorphine; cefalexin (keflex); ciprofloxacin hydrochloride; clotrimazole; dexamethasone (decadron); dicycloverine hydrochloride (bentyl); doxazosin mesilate (cardura); influenza vaccine inact split 4v (fluzone quadrivalent); fluconazole; fluticasone propionate; gemfibrozil (lopid); levothyroxine sodium (synthroid); levothyroxine sodium (levothroid); metronidazole (flagyl); nystatin; omeprazole (prilosec [omeprazole]); oxycodone hydrochloride, paracetamol (percocet); pneumococcal vaccine conj 13v (crm197) (prevnar 13); pregabalin (lyrica); pseudoephedrine hydrochloride (sudafed) for nasal congestion; sucralfate (carafate); tamsulosin hydrochloride (flomax relief); diclofenac (voltaren); ibuprofen (advil); ibuprofen (motrin); ketorolac (toradol) for pain; clopidogrel bisulfate (plavix); asa (acetylsalicylic acid) and meloxicam (mobic).Patient was on steroid dose pack (from (b)(6) 2023) on (b)(6) 2023, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection (liquid solution) at dose of 48 mg 1 injection (once) in right knee (intra-articular) (site of injection: anterior lateral knee) (strength: 48mg/6ml) (with batch number drsl001 and expiry date oct-2025) for primary localized osteoarthrosis of right lower leg/bilat knees oa (osteoarthritis).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) (peripheral swelling), cramping legs to toes bilateral (muscle spasms), redness (injection site joint erythema) (condition aggravated), increased pain (right knee) (injection site joint pain) (condition aggravated) and lack of efficacy (device ineffective).On (b)(6) 2023 next day (latency: 1 day) the patient's knees swelled 4 times their size they were normally (injection site joint swelling, caused disability), had severe pain in their muscles (myalgia, caused disability).It was reported that patient already put ice on them but that did not help.This was first time this happened.They already followed up with their prescribing physician who acknowledged that they have seen similar reaction only couple times in their career and was thinking that it might be that the patient could not handle the dose that was administered.They switched to another physician who recommended total knee replacement since the pain seemed to have traveled from their knees to their hip (arthralgia, pain, caused disability) and even part of the stomach when sitting down (abdominal pain upper) (onset: 30-mar-2023, latency: 1 day).They stated that adverse event knocked them down differently since they were on a wheelchair now and cannot stand for very long (dysstasia, onset 2023 and latency: unknown, caused disability).They also mentioned that they could not touch the back and sides of their knees which was also why the new physician was recommending replacement.Patient was informed of the common side effects, timing of resolution, and common treatments but referred them to their health care providers for further medical advice.It was also reported that the patient was still experiencing symptoms despite treatment.On an unknown date, in 2023 after an unknown latency, patient had a "major reaction" after injection in both knees.He had swelling in his ankle (joint swelling) (serious disability) and his "muscle is just recovering".He had to use a walker for ambulation.He said the nurse attributed the ankle swelling to standing.On an unknown date, after an unknown latency, patient had pain (pain) and sensitivity to clothes, including pants, socks, and boots (hyperaesthesia), had disturbed his sleep (sleep disorder) and he had trouble getting out of the bed (mobility decreased).He stated he apparently cannot tolerate synvisc one, causing an allergic reaction (hypersensitivity) which makes his skin itch (pruritus) and feel like it is "on fire" (skin burning sensation), and he had whelps on his skin (urticaria).Patient stated that he regretted getting the injections and it had been "hell".He reported the hcp (health care professional) said it was way too much for his body to handle and the medication was "seeping out causing foot and ankle swelling.He said it had leaked into out of his knees and into muscle.He said there was "no cartilage after the shot (cartilage damage)".He said he had hypertension after the injections and a history of heart disease which was prior to the injections.He said the medication got into his blood stream.He was sick for a month(illness) and had to be hospitalized for "massive blood clot (thrombosis)" and could not take therapy.It was reported on (b)(6) 2023, per pt(patient) he was not drinking enough water, so will increase and tried pickle just and seemed 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 (doctor) wanted to try a medrol dose pack, but patient was currently on prednisone 5 mg every other day for his legs 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 was 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.On (b)(6) 2023, patient told her the swelling was a little better this morning and no calf pain.Patient stated that swelling on his knee gone down a little.He called his pcp (primary care physician) and was advised to continued to follow up with doctor (surgery-orthopaedics) review of systems on (b)(6) 2023, patient had neurological: positive for weakness.(asthenia); positive for gait problem (gait disturbance) (latency:14 days).In (b)(6) 2023 the patient was prescribed celebrex and he stated that last night ((b)(6) 2023) he woke up to nausea and severe stomachache (abdominal pain upper) (latency: 18 days).Advised celebrex 200 mg helped for three days and then developed nausea, vomiting (n/v) and stomach cramping.Patient spoke with pharm, and now would like to try the 100 mg dose 1 x a day, will take after breakfast.He had also been to a gi (gastrointestinal) doctor for symptoms.Patient will be seeing cardiologist on (b)(6) 2023.On an unknown date in 2023 and few days latency he had had ct(computed tomography) scan and mri(magnetic resonance imaging) and had to have knee replacement in one knee which had been "rough".He now says he had knee replacement and that staples were removed.He will have the other knee replacement as well.On (b)(6) 2023, patient was scheduled for surgery and had ct (computerized tomography) with another scan scheduled prior to surgery.It was also reported that patient was having knee replacement and he was hoping to get the synvisc one out of his knees.He was told he would have extensive hospital stay for monitoring post op (post operation) and rehab (rehabilitation).He was seeing hcp (health care professional) today ((b)(6) 2023).He was taking otc (over the counter) pain medications.As of csd (b)(6) 2023, patient still continued to have sensitivity in his muscles which you "could not touch (hyperaesthesia) ".He still can barely walk (gait disturbance) and putting shoes on was difficult.He had no energy(asthenia) and had been sick on his stomach.He had muscle weakness in his legs (muscular weakness) and continued to have swelling in his knees, ankles and feet.He stated he wanted to know what caused this and when will it resolve.Relevant laboratory test results included: computerised tomogram - in 2023: [unknown results] and on (b)(6) 2023 arthrocentesis major done.Action taken: not applicable for all the events with synvisc-one; dose reduced for nausea, abdominal pain and vomiting and unknown for rest of the events with celecoxib (celebrex).Corrective treatment: using wheelchair for dysstasia, joint swelling, prednisone (deltasone) for peripheral swelling; ice for injection site joint swelling, arthralgia; otc (over the counter) medication (unspecified) for pain and myalgia; ice pack or injection site joint swelling, celebrex (short course of anti-inflammatories), home range of motion and strengthening program for injection site joint pain, knee replacement for weight bearing difficulty, dysstasia, injection site joint erythema, injection site joint swelling, injection site joint pain and not reported for rest events.Outcome: not recovered for dysstasia, weight bearing difficulty, joint swelling, peripheral swelling, injection site joint swelling, injection site joint erythema, hyperaesthesia, gait disturbance; recovering for myalgia, injection site joint pain, arthralgia; unknown for rest of the events.Seriousness criteria: disability and intervention required for dysstasia, disability for myalgia, joint swelling, arthralgia; disability and medically significant and intervention required for trouble (wb) right knee; disability and medically significant for peripheral swelling; intervention required, medically significant and disability for injection site joint erythema, injection site joint swelling, injection site joint pain; medically significant and hospitalization for thrombosis.A product technical complaint (ptc) was initiated on 15-may-2023 for synvisc one (lot/batch number: unknown) with global ptc number: 100327886.The sample status of the ptc was not available.Ptc stated: complaint: adverse event.Based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class had been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective action and preventive action) was required.The final investigation was completed on 11-jul-2023 with summarized conclusion as no assessment possible.Additional information was received on 15-may-2023 from other healthcare professional (from quality department).Product strength and ptc number was added.Upon internal review, action taken was updated to unknown from not applicable for all the events.Text amended accordingly.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly.Additional information was received on 31-may-2023 from the patient.New events: had swelling in his ankle, he apparently cannot tolerate synvisc, causing an allergic reaction, it has disturbed his sleep, trouble getting out of the bed, sensitivity to clothes, including pants, socks, and boots and pain were added.Outcome for myalgia was updated.Text amended.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).Concomitant medications, medical history added, batch number, expiry date, dose, route of suspect added, suspect updated from synvisc to synvisc one, events added.Co-suspect celebrex added.Clinical course was updated and text amended accordingly.Additional information was received on 07-jul-2023 from other healthcare professional quality department.Ptc reopened information added.Text amended accordingly.Additional information was received on 11-jul-2023 from other healthcare professional via quality department.Product updated from synvisc to synvisc one in investigation summary.Final investigation date updated.Text amended accordingly.Additional information was received on 14-jul-2023 from a patient.New event of massive blood clot, no cartilage after the shot, trouble getting out of the bed, has muscular weakness in his legs, hypertension after the injections, sick for a month added along with details.Verbatim of the event joint swelling updated to had swelling in his ankle//the medication was seeping out causing ankle swelling; verbatim of peripheral swelling updated to swelling down legs/ calves/increased in swelling knees and calves especially the left knee/swelling in his knees, ankles and feet/ the medication was seeping out causing foot swelling; verbatim of asthenia updated to neurological: positive for weakness/no energy; verbatim of hyperaesthesia updated to sensitivity to clothes, including pants, socks, and boots/continues to have sensitivity in his muscles which you "could not touch", verbatim for gait disturbance updated to musculoskeletal: positive for gait problem/still can barely walk.Outcome of the events updated.Clinical course was updated and text amended accordingly.

Event Description

Adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long [difficulty in standing] trouble (wb) right knee [weight bearing difficulty] ([condition aggravated]) swelling down legs/ calves/increased in swelling knees and calves especially the left knee [peripheral swelling] ([condition aggravated]) severe pain in their muscles [muscle pain] increased redness (right knee) [injection site joint erythema] ([condition aggravated]) had swelling in his ankle [ankle swelling] knees swelled 4 times their size/increased swelling/lot of swelling (right knee) [injection site joint swelling] ([condition aggravated]) increased pain/severe pain with weight bearing (right knee)/pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [injection site joint pain] ([device ineffective], [condition aggravated], [radiating pain]) pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [pain in hip] neurological: positive for weakness [weakness] it has disturbed his sleep [sleep disturbance] pain and sensitivity to clothes, including pants, socks, and boots [pain] sensitivity to clothes, including pants, socks, and boots [increased skin sensitivity] trouble getting out of the bed [mobility decreased] pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/severe stomach ache/stomach cramping [stomach pain] vomiting [vomiting] cramping legs to toes [pain in extremity] nausea [nausea] musculoskeletal: positive for gait problem [gait disturbance] he apparently cannot tolerate synvisc one, causing an allergic reaction [allergic reaction] ([itchy skin], [skin burning sensation], [welts]).Case narrative: initial information was received from united states on 15-may-2023 regarding an unsolicited valid serious case from a patient.This case is linked to cases: (b)(4) (synvisc-one left knee) (multiple devices suspect for the same patient) and (b)(4) (duplicate case).This case involves a 71 years old male patient who had adverse event that knocked them down differently since they are on a wheel chair now and cannot stand for very long, trouble (wb-weight bearing) right knee, swelling down legs/ calves/increased in swelling knees and calves especially the left knee , severe pain in their muscles, increased redness (right knee), had swelling in his ankle, knees swelled 4 times their size/increased swelling/lot of swelling (right knee), increased pain (right knee), pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/severe stomach ache/stomach cramping, neurological: positive for weakness, it has disturbed his sleep, pain and sensitivity to clothes, including pants, socks, and boots, trouble getting out of the bed, nausea, musculoskeletal: positive for gait problem , cramping legs to toes bilateral and he apparently cannot tolerate synvisc one, causing an allergic reaction after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and celecoxib (celebrex).The patient's past medical history included he had trouble with their knees in the past and they get injections every week for 3 weeks.He had knee pain for years increased with weightbearing activities such as walking.He had recurring swelling (knees).Had trouble bending knees.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) 2022 helped for a couple of months.He had increased symptoms since he fell fishing first week of (b)(6) 2022.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 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), postoperative nausea and vomiting past surgical history: circumcision, finder surgery right, inner ear surgery bilateral, knee surgery right, arthrocentesis major.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 the patient's family history was not provided.Concomitant medications included alprazolam (xanax); azelastine hydrochloride (astelin); baclofen (lioresal); buprenorphine; cefalexin (keflex); ciprofloxacin hydrochloride; clotrimazole; dexamethasone (decadron); dicycloverin hydrochloride (bentyl); doxazosin mesilate (cardura); influenza vaccine inact split 4v (fluzone quadrivalent); fluconazole; fluticasone propionate; gemfibrozil (lopid); levothyroxine sodium (synthroid); levothyroxine sodium (levothroid); metronidazole (flagyl); nystatin; omeprazole (prilosec [omeprazole]); oxycodone hydrochloride, paracetamol (percocet); pneumococcal vaccine conj 13v (crm197) (prevnar 13); pregabalin (lyrica); pseudoephedrine hydrochloride (sudafed) for nasal congestion; sucralfate (carafate); tamsulosin hydrochloride (flomax relief); diclofenac (voltaren); ibuprofen (advil); ibuprofen (motrin); ketorolac (toradol) for pain; meloxicam (moricam); clopidogrel bisulfate (plavix); asa (acetylsalicylic acid) and meloxicam (mobic).Patient was on steroid dose pack (from (b)(6) 2023).On (b)(6) 2023, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection at dose of 48 mg 1 injection (once) in right knee (intra-articular) (site of injection: anterior lateral knee) (strength: 48mg) (with batch number drsl001 and expiry date oct-2025) for primary localized osteoarthrosis of right lower leg/bilat knees oa (osteoarthritis).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) (peripheral swelling), cramping legs to toes bilateral (pain in extremity), redness (injection site joint erythema) (condition aggravated), increased pain (right knee) (injection site joint pain) (condition aggravated) and lack of efficacy (device ineffective).On (b)(6) 2023 next day (latency: 1 day) the patient's knees swelled 4 times their size they were normally (injection site joint swelling, caused disability), had severe pain in their muscles (myalgia, caused disability).It was reported that patient already put ice on them but that did not help.This was first time this happened.They already followed up with their prescribing physician who acknowledged that they have seen similar reaction only couple times in their career and was thinking that it might be that the patient could not handle the dose that was administered.They switched to another physician who recommended total knee replacement since the pain seemed to have traveled from their knees to their hip (arthralgia, pain, caused disability) and even part of the stomach when sitting down (abdominal pain upper) (onset: (b)(6) 2023, latency: 1 day).They stated that adverse event knocked them down differently since they were on a wheelchair now and cannot stand for very long (dysstasia, onset and latency: unknown, caused disability).They also mentioned that they could not touch the back and sides of their knees which was also why the new physician was recommending replacement.Patient was informed of the common side effects, timing of resolution, and common treatments but referred them to their health care providers for further medical advice.It was also reported that the patient was still experiencing symptoms despite treatment.On an unknown date, in 2023 after an unknown latency, patient had a "major reaction" after injection in both knees.He had swelling in his ankle (joint swelling) (serious disability) and his "muscle is just recovering".He had to use a walker for ambulation.He said the nurse attributed the ankle swelling to standing.On an unknown date, after an unknown latency, patient had pain (pain) and sensitivity to clothes, including pants, socks, and boots (hyperaesthesia), had disturbed his sleep (sleep disorder) and he had trouble getting out of the bed (mobility decreased).He stated he apparently cannot tolerate synvisc one, causing an allergic reaction (hypersensitivity) which makes his skin itch (pruritus) and feel like it is "on fire" (skin burning sensation), and he had whelps on his skin (urticaria).Patient stated that he regretted getting the injections and it had been "hell".It was reported on (b)(6) 2023, per pt(patient) he was not drinking enough water, so will increase and tried pickle just and seemed 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 (doctor) wanted to try a medrol dose pack, but patient was currently on prednisone 5 mg every other day for his legs 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 was 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.On (b)(6) 2023, patient told her the swelling was a little better this morning and no calf pain.Patient stated that swelling on his knee gone down a little.He called his pcp (primary care physician) and was advised to continued to follow up with doctor (surgery-orthopaedics).Review of systems on (b)(6) 2023, patient had neurological: positive for weakness.(asthenia); positive for gait problem (gait disturbance) (latency:14 days).In (b)(6) 2023 the patient was prescribed celebrex and he stated that last night (b)(6) 2023 he woke up to nausea and severe stomachache (abdominal pain upper) (latency: 18 days).Advised celebrex 200 mg helped for three days and then developed nausea, vomiting (n/v) and stomach cramping.Patient spoke with pharm, and now would like to try the 100 mg dose 1 x a day, will take after breakfast.He had also been to a gi (gastrointestinal) doctor for symptoms.Patient will be seeing cardiologist on (b)(6) 2023.On (b)(6) 2023, patient was scheduled for surgery and had ct (computerized tomography) with another scan scheduled prior to surgery.It was also reported that patient was having knee replacement and he was hoping to get the synvisc one out of his knees.He was told he would have extensive hospital stay for monitoring post op and rehab.He was seeing hcp (health care professional) today(b)(6) 2023.He was taking otc (over the counter) pain medications.Relevant laboratory test results included: computerised tomogram - in 2023: [unknown results] and on (b)(6) 2023 arthrocentesis major done.Action taken: not applicable for all the events with synvisc-one; dose reduced for nausea, abdominal pain and vomiting and unknown for rest of the events with celecoxib (celebrex).Corrective treatment: using wheelchair for dysstasia, joint swelling, prednisone (deltasone) for peripheral swelling; ice for injection site joint swelling, arthralgia; otc (over the counter) medication (unspecified) for pain and myalgia; ice pack or injection site joint swelling, celebrex (short course of anti-inflammatories), home range of motion and strengthening program for injection site joint pain and not reported for rest events.Outcome: not recovered for dysstasia, weight bearing difficulty, injection site joint erythema; recovering for myalgia, injection site joint pain, joint swelling, peripheral swelling, injection site joint swelling, arthralgia; unknown for rest of the events.Seriousness criteria: disability for dysstasia, myalgia, joint swelling, arthralgia; disability and medically significant for trouble (wb) right knee and peripheral swelling; injection site joint erythema, injection site joint swelling, injection site joint pain.A product technical complaint (ptc) was initiated on 15-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: complaint: adverse event.Based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class had been updated to ii.((b)(6) 2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective action and preventive action) was required.Ptc had been reopened.The final investigation was completed on 30-may-2023 with summarized conclusion as no assessment possible.The complaint (b)(4) for usa had been reopened for the following reason: incomplete complaint information.Additional information was received on 15-may-2023 from other healthcare professional (from quality department).Product strength and ptc number was added.Upon internal review, action taken was updated to unknown from not applicable for all the events.Text amended accordingly.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly.Additional information was received on 31-may-2023 from the patient.New events: had swelling in his ankle, he apparently cannot tolerate synvisc, causing an allergic reaction, it has disturbed his sleep, trouble getting out of the bed, sensitivity to clothes, including pants, socks, and boots and pain were added.Outcome for myalgia was updated.Text amended.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).Concomitant medications, medical history added, batch number, expiry date, dose, route of suspect added, suspect updated from synvisc to synvisc one, events added.Co-suspect celebrex added.Clinical course was updated and text amended accordingly.

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Brand Name

SYNVISC ONE

Type of Device

MOZ

Manufacturer (Section D)

GENZYME CORPORATION(RIDGEFIELD)

1125 pleasantview terrace

ridgefield 07657

Manufacturer (Section G)

GENZYME CORPORATION(RIDGEFIELD)

1125 pleasantview terrace

ridgefield 07657

Manufacturer Contact

heather schiappacasse

55 corporate drive, ms 55b-220

bridgewater 08807

MDR Report Key

16962210

MDR Text Key

315753079

Report Number

2246315-2023-00050

Device Sequence Number

Product Code

MOZ

Combination Product (y/n)

Reporter Country Code

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Health Professional

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Lot Number

DRSL001

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

05/19/2023

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided
Not provided
Not provided
Not provided

Supplement Dates FDA Received

05/23/2023
06/01/2023
06/06/2023
07/05/2023
07/14/2023
07/26/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention; Disability; Hospitalization;

Patient Sex

Male

Patient Weight

68 KG

Patient Race

White

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

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