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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ
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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ Back to Search Results
Lot Number DRSL001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myalgia (2238); Arthralgia (2355); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); 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
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 (left knee) [injection site joint swelling], pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down (left knee) [arthralgia] ([radiating pain]) pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [stomach pain].Case narrative: initial information received from united states on 15-may-2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case (b)(4) (multiple devices suspect for same patient).This case involves a 70 years old male patient whose knees swelled 4 times their size (left knee), experienced severe pain in their muscles, pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down and adverse event knocked them down differently since they are on a wheel chair now 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 for 3 weeks.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6)2022, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) injection at dose of 1 injection in each knee (with unknow strength, 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), had severe pain in their muscles (myalgia).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 since the pain seemed to have traveled from their knees to their hip (arthralgia and pain) 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 are on a wheel chair now and cannot stand for very long (dysstasia, onset and latency: unknown).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: unknown for all the events.Corrective treatment: using wheelchair for dysstasia; ice for injection site joint swelling, arthalgia and its symptom and myalgia and not reported for abdominal pain upper.Outcome: not recovered for all the events.Seriousness criteria: disability for injection site joint swelling, myalgia, arthralgia and dysstasia.A product technical complaint (ptc) was initiated, and the results were pending for the same.
 
Manufacturer Narrative
Sanofi company comment dated 18-may-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 and cannot stand for very long, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient was on a wheel chair now (causing disability).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, injection technique, post injection routine, batch number details, investigation results, and other risk factors would aid in better case assessment.In addition, history of unspecified disorder of knee joint could be a 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 (left knee) [injection site joint swelling].Pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down (left knee) [arthralgia] ([radiating pain]).Pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [stomach pain].Case narrative: initial information received from united states on 15-may-2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case: (b)(4) (multiple devices suspect for same patient).This case involves a 70 years old male patient whose knees swelled 4 times their size (left knee), experienced severe pain in their muscles, pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down and adverse event knocked them down differently since they are on a wheel chair now 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 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 having the strength 16mg/2ml (with unknown 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), had severe pain in their muscles (myalgia).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 since the pain seemed to have traveled from their knees to their hip (arthralgia and pain) and even part of the stomach when sitting down (abdominal pain upper) (onset: on (b)(6) 2022, latency:1 day).They stated that adverse event knocked them down differently since they are on a wheel chair now and cannot stand for very long (dysstasia, onset and latency: unknown).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: unknown for all the events.Corrective treatment: using wheelchair for dysstasia; ice for injection site joint swelling, arthalgia and its symptom and myalgia and not reported for abdominal pain upper.Outcome: not recovered for all the events.Seriousness criteria: disability for injection site joint swelling, myalgia, arthralgia and dysstasia.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: 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) is required.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 the quality department.Ptc number and strength was added.Additional information was received on 30-may-2023 from quality department.Ptc details added.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] severe pain in their muscles [muscle pain] knees swelled 4 times their size (left knee) [injection site joint swelling] pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down (left knee) [arthralgia] ([radiating pain]) pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down [stomach pain] case narrative: initial information received from united states on 15-may-2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case (b)(4) (multiple devices suspect for same patient) this case involves a 70 years old male patient whose knees swelled 4 times their size (left knee), experienced severe pain in their muscles, pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down and adverse event knocked them down differently since they are on a wheel chair now 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 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 having the strength 16mg/2ml (with unknow 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), had severe pain in their muscles (myalgia).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 since the pain seemed to have traveled from their knees to their hip (arthralgia and pain) 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 are on a wheel chair now and cannot stand for very long (dysstasia, onset and latency: unknown).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: unknown for all the events corrective treatment: using wheelchair for dysstasia; ice for injection site joint swelling, arthalgia and its symptom and myalgia and not reported for abdominal pain upper.Outcome: not recovered for all the events seriousness criteria: disability for injection site joint swelling, myalgia, arthralgia and dysstasia 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 was not available and the complaint was set in process.Additional information was received on 15-may-2023 from the quality department.Ptc number and strength was added.
 
Manufacturer Narrative
Sanofi company comment for follow up dated 15-may-2023: follow up information received does not change prior case assessment.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).The patient was on a wheel chair now (causing disability).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, injection technique, post injection routine, batch number details, investigation results, and other risk factors would aid in better case assessment.In addition, history of unspecified disorder of knee joint could be a confounding factor in this case.
 
Manufacturer Narrative
Sanofi company comment for follow up dated 23-jun-2023: this case 71 years old male patient who had 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, swelling down legs/ calves, trouble wb(weight bearing)(left knee) after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient was on a wheel chair now (causing disability).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, injection technique, post injection routine, batch number details, investigation results, and other risk factors would aid in better case assessment.In addition, history of unspecified disorder of knee joint could be a 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] swelling down legs/ calves [peripheral swelling] trouble wb(left knee) [weight bearing difficulty] ([condition aggravated]) severe pain in their muscles [muscle pain] knees swelled 4 times their size (left knee) [injection site joint swelling] ([condition aggravated]) pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down/swelling down legs / scales(left knee) [injection site joint pain] ([condition aggravated]) redness(left knee) [injection site joint erythema] ([condition aggravated]) arthrocentesis, major(left knee) [arthrocentesis] pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/stomach ache [stomach pain] musouloskeiebal; positive for gait problem [gait disorder] neurological: positive for weakness.[generalised muscle weakness] limited in the flexion of the left knee feels tightness [joint stiffness] nausea [nausea] lack of efficacy / failure [device ineffective] case narrative: initial information received from united states on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case (b)(4) (multiple devices suspect for same patient: right knee) this case involves a 71 years old male patient who had 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, swelling down legs/ calves, trouble wb(weight bearing)(left knee), knees swelled 4 times their size (left knee), pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down/swelling down legs / scales(left knee), redness(left knee), arthrocentesis, major(left knee), pain seemed to have traveled from their knees to their hip and even part of the stomach when sitting down/stomach ache, neurological: positive for weakness, nausea and lack of efficacy / failure after 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: (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); cefalexin (keflex [cefalexin]); ciprofloxacin hydrochloride (ciprofloxacin hydrochloride); clotrimazole (clotrimazole); dexamethasone (decadron [dexamethasone]); dicycloverine hydrochloride (bentyl); doxazosin mesilate (cardura); influenza vaccine inact split 4v (fluzone quadrivalent); fluconazole (fluconazole); fluticasone propionate (fluticasone propionate); gemfibrozil (lopid); levothyroxine sodium (synthroid); levothyroxine sodium (levothroid); 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 relief); diclofenac (voltaren [diclofenac]); ibuprofen (advil [ibuprofen]); ibuprofen (motrin [ibuprofen]); ketorolac (toradolin) for pain; piroxicam (mobicam [piroxicam]); clopidogrel bisulfate (plavix); and asa (asa).On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in the left knee at a dose of 48 mg 1x (once) via intra-articular (lot - drsl001, expiry date: october 2025) for primary localized osteoarthrosis of left lower leg/ bilat knees oa.(strength: uknown)(site of injection: anterior lateral) on (b)(6) 2023, latency: same day, patient had arthrocentesis, major (left knee) (aspiration joint) performed on (b)(6) 2023 next day (latency: 1 day) the patient's knees swelled 4 times their size (injection site joint swelling)(condition aggravated), had severe pain in their muscles (myalgia).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 was 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 since the pain seemed to have traveled from their knees to their hip (injection site joint pain)(condition aggravated) 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 are on a wheel chair now and cannot stand for very long (dysstasia, onset: 2023; and latency: unknown).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.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(left 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(joint stiffness; onset: (b)(6) 2023; latency: unknown) 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; patient had neurological: positive for weakness.(muscular weakness); positive for gait problem(gait disturbance) (unknown latency).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 the events corrective treatment: using wheelchair for dysstasia; ice for injection site joint swelling and myalgia and prednisone (deltasone [prednisone]) for peripheral swelling and celecoxib (celebrex) for nausea and abdominal pain upper and not reported for rest events outcome: the outcome was recovering for the event injection site joint swelling , and was unknown for nausea, abdominal pain upper, joint stiffness, aspiration joint, muscular weakness, gait disturbance and not recovered for all the 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 and disability for myalgia and dysstasia.A product technical complaint (ptc) was initiated on (b)(6) 2023 for hylan g-f 20, sodium hyaluronate (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: based on the complaint from intake team, there was 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.The product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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) s required.The final investigation was completed on 30-may-2023 with summarized conclusion as no assessment possible.The complaint (b)(4) has been reopened for the following reason: sample received late or unexpected.Additional information was received on 15-may-2023 from the quality department.Ptc number and strength was added.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly follow-up information was received on 01-jun-2023 from quality department.Ptc reopened information added.Additional information was received on 23-jun-2023 from non-healthcare professional: medical history added; dosing details and indication added; lab added; as reported term and outcome of event abdominal pain upper updated; event of injection site joint erythema, injection site joint swelling , injection site joint pain, peripheral swelling , arthrocentesis, nausea, gait disturbance , weight bearing difficulty, device ineffective , muscular weakness, joint stiffness added; event of arthralgia deleted; therapy dates updated; onset of events updated; suspect updated to synvisc one, clinical course updated; text amended.
 
Manufacturer Narrative
Sanofi company comment for follow up dated 11-jul-2023: 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) left knee, swelling down legs/ calves/increased in swelling knees and calves especially the left knee , severe pain in their muscles, increased redness (left knee), had swelling in his ankle, knees swelled 4 times their size/increased swelling/lot of swelling (left knee), increased pain (left 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, limited in the flexion of the left knee feels tightness after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and celecoxib (celebrex).The patient was on a wheelchair now (causing disability).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, injection technique, post injection routine, batch number details, investigation results, and other risk factors would aid in better case assessment.In addition, history of unspecified disorder of knee joint could be a 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] trouble wb(left knee) [weight bearing difficulty] ([condition aggravated]) pain in hip [pain in hip] had swelling in his ankle [ankle swelling] 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 (left knee) [injection site joint erythema] ([condition aggravated]) knees swelled 4 times their size/increased swelling/lot of swelling (left knee) [injection site joint swelling] ([condition aggravated]) increased pain/pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down [injection site joint pain] ([condition aggravated], [device ineffective], [radiating pain]) neurological: positive for weakness [weakness] it has disturbed his sleep [sleep disturbed] pain and sensitivity to clothes, including pants, socks, and boots [pain of skin] pain and sensitivity to clothes, including pants, socks, and boots [increased skin sensitivity] trouble getting out of 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] musouloskeiebal; positive for gait problem [gait disorder] limited in the flexion of the left knee feels tightness [joint stiffness] he apparently cannot tolerate synvisc one, causing an allergic reaction [allergic reaction] ([skin burning sensation], [welts], [itchy skin]) case narrative: initial information received from united states on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case (b)(4) (multiple devices suspect for same patient: right knee), (b)(4) (duplicate case- deleted).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) left knee, swelling down legs/ calves/increased in swelling knees and calves especially the left knee , severe pain in their muscles, increased redness (left knee), had swelling in his ankle, knees swelled 4 times their size/increased swelling/lot of swelling (left knee), increased pain (left 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, limited in the flexion of the left knee feels tightness 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 (b)(6) 2022 helped for a couple of months.He had 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 (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 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; 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); 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 one (hylan g-f 20, sodium hyaluronate) injection in the left knee at a dose of 48 mg 1x (once) via intra-articular (lot - drsl001, expiry date: october 2025) for primary localized osteoarthrosis of left lower leg/ bilat knees oa (osteoarthritis) (strength: 48mg/6ml) (site of injection: anterior lateral) 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 (left 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: 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".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 (joint stiffness; onset date (b)(6) 2023; latency: unknown) 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) left 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 hylan g-f 20, sodium hyaluronate (lot/batch number: unknown) with global ptc number: (b)(4).Signals.The defect class has 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 was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 the quality department.Ptc number and strength was added.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly follow-up information was received on 01-jun-2023 from quality department.Ptc reopened information added.Additional information was received on 23-jun-2023 from non-healthcare professional: medical history added; dosing details and indication added; lab added; as reported term and outcome of event abdominal pain upper updated; event of injection site joint erythema, injection site joint swelling , injection site joint pain, peripheral swelling , arthrocentesis, nausea, gait disturbance , weight bearing difficulty, device ineffective , muscular weakness, joint stiffness added; event of arthralgia deleted; therapy dates updated; onset of events updated; suspect updated to synvisc one, clinical course updated; text amended follow up 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 healthcare professional via quality department.Strength of synvisc one updated.Upon internal review: event of arthrocentesis, major (left knee) deleted and arthrocentesis, major added as medical history; lab data added; events of nausea, vomiting, hypersensitivity, arthralgia, joint swelling, pain of skin, hyperaesthesia, sleep disorder, mobility decreased, pain in extremity added along with details; verbatim of events updated.Clinical course was updated and 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(left knee) [weight bearing difficulty] ([condition aggravated]) pain in hip [pain in hip] had swelling in his ankle/the medication was seeping out causing ankle swelling [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 [peripheral swelling] ([condition aggravated]) severe pain in their muscles [muscle pain] increased redness (left knee) [injection site joint erythema] ([condition aggravated]) knees swelled 4 times their size/increased swelling/lot of swelling (left knee) [injection site joint swelling] ([condition aggravated]) increased pain/pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down [injection site joint pain] ([condition aggravated], [device ineffective], [radiating pain]) neurological: positive for weakness/no energy [feeling of total lack of energy] it has disturbed his sleep [sleep disturbed] pain and sensitivity to clothes, including pants, socks, and boots [pain of skin] pain and 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] limited in the flexion of the left knee feels tightness [joint range of motion decreased] trouble getting out of 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/sick on his stomach [stomach pain] vomiting [vomiting] has muscle weakness in his legs [muscle weakness lower limb] hypertension after the injections [hypertension] sick for a month [sickness] cramping legs to toes [muscle cramps] nausea [nausea] musculoskeletal; positive for gait problem/still can barely walk [difficulty in walking] he apparently cannot tolerate synvisc one, causing an allergic reaction [allergic reaction] ([skin burning sensation], [welts], [itchy skin]) limited in the flexion of the left knee feels tightness [joint stiffness] case narrative: initial information received from united states on 15-may-2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case (b)(4) (multiple devices suspect for same patient: right knee), (b)(4) (duplicate case- deleted).This case involves 71 years old male patient who had 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(left knee), pain in hip, 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 (left knee), knees swelled 4 times their size/increased swelling/lot of swelling (left knee), increased pain/pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down, neurological: positive for weakness/no energy, it had disturbed his sleep, pain and sensitivity to clothes, including pants, socks, and boots, 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, limited in the flexion of the left knee feels tightness, trouble getting out of bed, 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/sick on his stomach, vomiting, had muscle weakness in his legs, hypertension after the injections, sick for a month, cramping legs to toes, nausea, musculoskeletal; positive for gait problem/still can barely walk , he apparently cannot tolerate synvisc one, causing an allergic reaction ; feels tightness 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 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 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 were 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 were 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 were 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; 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: 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 one (hylan g-f 20, sodium hyaluronate) injection in the left knee at a dose of 48 mg 1x (once) via intra-articular (lot - drsl001, expiry date: october 2025) for primary localized osteoarthrosis of left lower leg/ bilat knees oa (osteoarthritis) (strength: 48mg/6ml) (site of injection: anterior lateral) on (b)(6) 2023; latency: 1 day patient was having issues with his both knees post injections (major reaction after the injection).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 cramps), redness (injection site joint erythema) (condition aggravated), increased pain (left 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: 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.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 (joint range of motion decreased) (joint stiffness; onset date (b)(6) 2023; latency: unknown) 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 (operation)and rehab.He was seeing hcp (health care professional) today ((b)(6) 2023).He was taking otc (over the counter) pain medications.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 was 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 was "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.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.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 continues to have swelling in his knees, ankles and feet.He stated he wanted to know what caused this and when will it resolve.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 pack for injection site joint swelling, arthralgia, myalgia; otc (over the counter) medication (unspecified) for pain and myalgia; 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, hyperaesthesia, weight bearing difficulty, injection site joint erythema, injection site joint swelling, joint swelling, peripheral swelling, gait disturbance; recovering for myalgia, injection site joint pain, arthralgia; unknown for rest of the events seriousness criteria: disability for dysstasia, myalgia, joint swelling, arthralgia; disability and medically significant for trouble (wb) left knee and peripheral swelling; injection site joint erythema, injection site joint swelling, injection site joint pain; hospitalized and medically significant for thrombosis a product technical complaint (ptc) was initiated on 15-may-2023 for hylan g-f 20, sodium hyaluronate (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: adverse event preliminary assessment: based on the complaint from intake team, there was 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 was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 the quality department.Ptc number and strength was added.Additional information was received on 30-may-2023 from quality department.Ptc details added.Text amended accordingly follow-up information was received on 01-jun-2023 from quality department.Ptc reopened information added.Additional information was received on 23-jun-2023 from non-healthcare professional: medical history added; dosing details and indication added; lab added; as reported term and outcome of event abdominal pain upper updated; event of injection site joint erythema, injection site joint swelling , injection site joint pain, peripheral swelling , arthrocentesis, nausea, gait disturbance , weight bearing difficulty, device ineffective , muscular weakness, joint stiffness added; event of arthralgia deleted; therapy dates updated; onset of events updated; suspect updated to synvisc one, clinical course updated; text amended follow up 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 healthcare professional via quality department.Strength of synvisc one updated.Upon internal review: event of arthrocentesis, major (left knee) deleted and arthrocentesis, major added as medical history; lab data added; events of nausea, vomiting, hypersensitivity, arthralgia, joint swelling, pain of skin, hyperaesthesia, sleep disorder, mobility decreased, pain in extremity added along with details; verbatim of events updated.Clinical course was updated, and text amended accordingly.Additional information was received on 17-jul-2023 from healthcare professional via quality department.The complaint (b)(4) for usa had been reopened for the following reason: incomplete complaint information; no significant information received; text amended accordingly additional information was received on 14-jul-2023 (captured in general tab as 17-jul-2023 to avoid e2b negative acknowledgement) from patient: event of thrombosis, joint range of motion decreased, muscular weakness, cartilage injury, hypertension, illness added; as reported term of event asthenia, abdominal pain upper, peripheral swelling updated; outcome of events updated; clinical course was updated and text amended accordingly.Upon internal review on 19-jul-2023, this case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) has been merged in the case (b)(4).Case (b)(4) with csd of 31-may-2023, would be deleted.
 
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(left knee) [weight bearing difficulty] ([condition aggravated]) pain in hip [pain in hip] had swelling in his ankle/the medication was seeping out causing ankle swelling [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 [peripheral swelling] ([condition aggravated]) severe pain in their muscles [muscle pain] increased redness (left knee) [injection site joint erythema] ([condition aggravated]) knees swelled 4 times their size/increased swelling/lot of swelling (left knee) [injection site joint swelling] ([condition aggravated]) increased pain/pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down [injection site joint pain] ([condition aggravated], [device ineffective], [radiating pain]) neurological: positive for weakness/no energy [feeling of total lack of energy] it has disturbed his sleep [sleep disturbed] pain and sensitivity to clothes, including pants, socks, and boots [pain of skin] pain and 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] limited in the flexion of the left knee feels tightness [joint range of motion decreased] trouble getting out of 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/sick on his stomach [stomach pain] vomiting [vomiting] has muscle weakness in his legs [muscle weakness lower limb] hypertension after the injections [hypertension] sick for a month [sickness] cramping legs to toes [muscle cramps] nausea [nausea] musculoskeletal; positive for gait problem/still can barely walk [difficulty in walking] he apparently cannot tolerate synvisc one, causing an allergic reaction [allergic reaction] ([skin burning sensation], [welts], [itchy skin]) limited in the flexion of the left knee feels tightness [joint stiffness] case narrative: initial information received from united states on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.This case is cross referred to the case (b)(4) (multiple devices suspect for same patient: right knee), (b)(4) (duplicate case- deleted).This case involves a 71 years old male patient who had 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(left knee), pain in hip, 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 (left knee), knees swelled 4 times their size/increased swelling/lot of swelling (left knee), increased pain/pain seemed to have traveled from their knees (left knee) to their hip and even part of the stomach when sitting down, neurological: positive for weakness/no energy, it had disturbed his sleep, pain and sensitivity to clothes, including pants, socks, and boots, 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, limited in the flexion of the left knee feels tightness, trouble getting out of bed, 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/sick on his stomach, vomiting, had muscle weakness in his legs, hypertension after the injections, sick for a month, cramping legs to toes, nausea, musculoskeletal; positive for gait problem/still can barely walk , he apparently cannot tolerate synvisc one, causing an allergic reaction ; feels tightness 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 were 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 were 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 were 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; 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: 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 one (hylan g-f 20, sodium hyaluronate) injection in the left knee at a dose of 48 mg 1x (once) via intra-articular (lot - drsl001, expiry date: october 2025) for primary localized osteoarthrosis of left lower leg/ bilat knees oa (osteoarthritis) (strength: 48mg/6ml) (site of injection: anterior lateral) 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 cramps), redness (injection site joint erythema) (condition aggravated), increased pain (left 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: 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.It was reported on (b)(6) 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(joint range of motion decreased) (joint stiffness; onset date (b)(6) 2023; latency: unknown) 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 (operation)and rehab.He was seeing hcp (health care professional) today ((b)(6) 2023).He was taking otc (over the counter) pain medications.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 was 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 was "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.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.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 continues to have swelling in his knees, ankles and feet.He stated he wanted to know what caused this and when will it resolve.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, hyperaesthesia , weight bearing difficulty, injection site joint erythema, injection site joint swelling, joint swelling, peripheral swelling, gait disturbance; recovering for myalgia, injection site joint pain, arthralgia; unknown for rest of the events.Seriousness criteria: disability for dysstasia, myalgia, joint swelling, arthralgia; disability and medically significant for trouble (wb) left knee and peripheral swelling; injection site joint erythema, injection site joint swelling, injection site joint pain; hospitalized and medically significant for thrombosis.A product technical complaint (ptc) was initiated on (b)(6) 2023 for hylan g-f 20, sodium hyaluronate (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: adverse event preliminary assessment: based on the complaint from intake team, there was 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 was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 (b)(6) 2023 with summarized conclusion as no assessment possible.Additional information was received on (b)(6) 2023 from the quality department.Ptc number and strength was added.Additional information was received on (b)(6) 2023 from quality department.Ptc details added.Text amended accordingly follow-up information was received on (b)(6) 2023 from quality department.Ptc reopened information added.Additional information was received on (b)(6) 2023 from non-healthcare professional: medical history added; dosing details and indication added; lab added; as reported term and outcome of event abdominal pain upper updated; event of injection site joint erythema, injection site joint swelling , injection site joint pain, peripheral swelling , arthrocentesis, nausea, gait disturbance , weight bearing difficulty, device ineffective , muscular weakness, joint stiffness added; event of arthralgia deleted; therapy dates updated; onset of events updated; suspect updated to synvisc one, clinical course updated; text amended follow up information was received on (b)(6) 2023 from other healthcare professional quality department.Ptc reopened information added.Text amended accordingly.Additional information was received on (b)(6) 2023 from healthcare professional via quality department.Strength of synvisc one updated.Upon internal review: event of arthrocentesis, major (left knee) deleted and arthrocentesis, major added as medical history; lab data added; events of nausea, vomiting, hypersensitivity, arthralgia, joint swelling, pain of skin, hyperaesthesia, sleep disorder, mobility decreased, pain in extremity added along with details; verbatim of events updated.Clinical course was updated, and text amended accordingly.Additional information was received on (b)(6) 2023 from healthcare professional via quality department.The complaint (b)(4) for usa had been reopened for the following reason: incomplete complaint information; no significant information received; text amended accordingly additional information was received on (b)(6) 2023 (captured in general tab as (b)(6) 2023 to avoid e2b negative acknowledgement) from patient: event of thrombosis, joint range of motion decreased, muscular weakness, cartilage injury, hypertension, illness added; as reported term of event asthenia, abdominal pain upper, peripheral swelling updated; outcome of events updated; 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
a
bridgewater 08807
MDR Report Key16969194
MDR Text Key315640492
Report Number2246315-2023-00051
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberDRSL001
Was Device Available for Evaluation? No
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability; Required Intervention;
Patient SexMale
Patient Weight68 KG
Patient RaceWhite
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