| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Positive antinuclear antibodies (ANA) (2015); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 02/02/2018 |
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Event Type
Injury
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Event Description
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Unable to bear weight and walk /significant difficulty ambulating [unable to walk], pseudoseptic reaction to synvisc [pseudosepsis], ([joint inflammation], [effusion (l) knee], [knee pain], [synovitis of knee], [swelling of l knee], [joint warmth], [discomfort]) erythema on her face [erythema facial].Unable to bear weight and walk [weight bearing difficulty].Certainly the neutrophil count is low [neutrophil count low].Range of motion is lacking 5 degrees of extension to 120 degrees of flexion [joint range of motion decreased].Leukocyte count outside range [white blood cell count abnormal].Eosinophil count low [eosinophil count low].Case narrative: initial information received on 10-feb-2020 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) year old female patient who experienced pseudoseptic reaction to synvisc (latency few days), erythema on her face ( latency 8 days), unable to bear weight and walk this morning, unable to bear weight and walk this morning/significant difficulty ambulating and certainly the neutrophil count is low (latency few days), range of motion is lacking 5 degrees of extension to 120 degrees of flexion, eosinophil count low and leukocyte count outside range (latency 7 days) while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one) and vancomycin (vancomycin).The patient's past medical history included dislocation of left patella in high school/patellar subluxations (with patient had a recurrent instability), cholecystectomy (8 years ago), familial hypercholesterolemia, cholestatic liver disease, worsening pain and instability while going down stairs in 2016, degenerative arthritis on left knee arthroscopy, patellar chondroplasty, intermittent instabilities of her left knee while walking, irritable bowel syndrome, diarrhea predominant ( in 2008), plantar fasciitis, right rotator cuff tendinopathy/achilles tendinopathy, nasal reconstruction, bakers cyst, left knee tibial tubercle anteromedialization on (b)(6) 2016, hospitalized, smaller effusion ((b)(6) 2015), cosmetic/plastic surgery, breast surgery, ldl remains high at 196, a lot of difficulty with walking (with lack of knee flexion during mid phases of gait deviations), had to go on crutches for a while, internal hemorrhoid (2017)limitation of motion and weakness.Patient had a family history of alcohol abuse (father), 1 daughter deceased and heart disease (grandparents).The patient's past medical treatment(s), vaccination(s) were not provided.At the time of the event, the patient had ongoing graves disease (with currently on levothyroxine for this), tobacco never used, left knee pain, allergies to sulfonamides/sulfa allergy (with rash, breathing difficulty, hives) and patellar pain (with symptoms are improving; frequency of symptoms is constant but intensity varies pain intensity: 8, aggravating factors: twisting, stairs, walking, squat, kneel, pivot).Concomitant medications included acetaminophen (acetaminophen) for arthralgia; docusate sodium (colace) for bowel movement irregularity; sodium chloride (sodium chloride); oxycodone (oxycodone); sennoside a+b (senna sennoside a+b); levothyroxine (levothyroxine); meropenem (meropenem); ciprofloxacin (ciprofloxacin); aspirin (acetylsalicylic acid); promethazine (promethazine); dextrose (dextrose); diclofenac sodium (voltaren (diclofenac sodium); rosuvastatin calcium (crestor); colesevelam (colesevelam); cyclosporine (cyclosporine); glyburide (glyburide); phenytoin (phenytoin); ethinylestradiol (ethinylestradiol); norethindrone (norethisterone); warfarin (warfarin); carbamazepine (carbamazepine); digoxin (digoxin); lithium carbonate (lithium carbonate); theophylline (theophylline); doxycycline (vibramycin); acetylsalicylic acid (ecotrin); and tramadol hydrochloride (ultram).On (b)(6) 2018, the patient received treatment with hylan g-f 20, sodium hyaluronate injection in left knee at unknown dose, via intraarticular route once (batch - 7rs027, september 2020) for left knee pain.After local anesthesia, 21 gauge needle was advanced under sonographic guidance to the suprapatellar recess and after sonographic confirmation of the needle tip within the suprapatellar recess, hylan g-f 20, sodium hyaluronate was injected with excellent arthrogram flow.Patient tolerated the procedure well without complications.On (b)(6) 2020, after two days, she developed a large effusion which was quite painful but which progressed to the point where she was having significant difficulty ambulating (intervention required, disability).No systemic symptoms of infection, such as fevers or chills.She had an aspirate done which has 9000 cells, 19 percent pmn, no crystals.Gram stain had a rare gram-negative bacillus but overall culture was negative.Broad range bacterial pcr sequencing on two specimens also detected no bacterial dna.On unknown date in (b)(6) 2018, after few days, left knee was inflamed.On (b)(6) 2018, after latency of 6 days, patient visited clinic because of left knee pain and swelling with slight warmth.She had 3+ effusion and range of motion of 10 to 70 degrees with pain.On same day, left was aspirated and corticosteroid was injected.A syringe of 5 cc of 1% lidocaine was injected into the skin and subcutaneous tissues at the superolateral knee.An 18 gauge needle was utilized to inject a solution of 4 cc of 1% lidocaine and 2 cc of depo-medrol into the left knee joint.The patient experienced immediate relief and was able to range the knee from 0 to 120 degrees without pain.After aspiration of left knee, a pseudo septic reaction was suspected (intervention required, disability).Cell count of the fluid was 9,122 nucleated cells with 19 percent neutrophils (neutrophils low), pain was 4/10, range of motion lacking 5 degrees of extension to 120 degrees of flexion with 1+ effusion and no warmth.On (b)(6) 2018, after 7 days, patient had pain and swelling in left knee,3+ effusion, was slight warmth and range of motion of 10 to 70 degrees with pain.Neutrophil count was 8.27 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5) and leukocyte count 10.8 10*9/l (outside normal range).On (b)(6) 2018, patient was admitted to hospital for left knee arthroplasty irrigation and debridement as patient had left knee pain.There were no complications during or immediately after the procedure and the patient was transferred to the general orthopedic floor postoperatively.However, it was reported that after this surgery, patient became dependent and started using crutches.It was planned to discharge the patient with home infusions for iv antibiotics if needed.On same day, post procedural septic arthritis (medically significant) was suspected in left knee and left knee synovial fluid was removed for more clarifications.On an unknown date in (b)(6) 2018, after few days latency, synovium left knee excision showed proliferative synovitis of left knee with chronic inflammation but no significant acute inflammation.Patient also complained of pain 6/10 when she woke up from sleep, for which she iced her knee.She was unable to bear weight and walk (disability).As of (b)(6) 2018, patient had some pain and discomfort but stated that she was doing well.Neutrophil count was 9.22 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5), glucose random high.On same day, patient had erythema on her face which occurred after the infusion of vancomycin today.Relevant laboratory test results included: magnetic resonance imaging - on (b)(6) 2015: (interval tibial tuberosity transfer with persistent lateral patellar subluxation/tilt, evidence of patellar-lateral femoral condyle friction, and mild progression of patellar chondromalacia with a new infra-articular loose body.) x-ray - in (b)(6) 2016: (left tibial tubercle transfer with screw fixation and lateral subluxation of the left patella.Degenerative changes in the patellofemoral joint.Lateral subluxation of the right patella).Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; unknown for vancomycin.Corrective treatment: left knee arthroplasty irrigation and debridement surgery crutches user, depomedrol,knee brace and partial synevedomy for pseudoseptic reaction to synvisc; crutch user for unable to bear weight and walk /significant difficulty ambulating; not reported for other events.Outcome: unknown for all events.A product technical complaint was initiated and results were pending for the same.
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Event Description
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Unable to bear weight and walk /significantdifficulty ambulating [unable to walk] pseudoseptic reaction to synvisc [pseudosepsis] ([joint inflammation], [effusion (l) knee], [knee pain], [synovitis of knee], [swelling of l knee], [joint warmth], [discomfort]) erythema on her face [erythema facial] unable to bear weight and walk [weight bearing difficulty] certainly the neutrophil count is low [neutrophil count low] range of motion is laclang 5 degrees of extension to 120 degrees of flexion [joint range of motion decreased] leukocyte count outside range [white blood cell count abnormal] eosinophil count low [eosinophil count low] case narrative: initial information received on 10-feb-2020 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) female patient who experienced pseudoseptic reaction to synvisc (latency few days), erythema on her face ( latency 8 days), unable to bear weight and walk this morning, unable to bear weight and walk this morning/significant difficulty ambulating and certainly the neutrophil count is low (latency few days), range of motion is lacking 5 degrees of extension to 120 degrees of flexion, eosinophil count low and leukocyte count outside range (latency 7 days) while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one) and vancomycin (vancomycin) the patient's past medical history included dislocation of left patella in high school/patellar subluxations (with patient had a recurrent instability), cholecystectomy (8 years ago), familial hypercholesterolemia , cholestatic liver disease ,worsening pain and instability while going down stairs in 2016, degenerative arthritis on left knee arthroscopy, patellar chondroplasty, intermittent instabilities of her left knee while walking, irritable bowel syndrome, diarrhea predominant ( in 2008), plantar fasciitis, right rotator cuff tendinopathy/achilles tendinopathy, nasal reconstruction, bakers cyst, left knee tibial tubercle anteromedialization on (b)(6) 2016, hospitalized, smaller effusion ( (b)(6) 2015), cosmetic/plastic surgery, breast surgery, ldl remains high at 196, a lot of difficulty with walking (with lack of knee flexion during mid phases of gait deviations), had to go on crutches for a while, internal hemorrhoid (2017)limitation of motion and weakness.Patient had a family history of alcohol abuse (father), 1 daughter deceased and heart disease (grandparents).The patient's past medical treatment(s), vaccination(s) were not provided.At the time of the event, the patient had ongoing graves disease (with currently on levothyroxine for this), tobacco never used, left knee pain, allergies to sulfonamides/sulfa allergy (with rash, breathing difficulty, hives) and patellar pain (with symptoms are improving; frequency of symptoms is constant but intensity varies pain intensity: 8, aggravating factors: twisting, stairs, walking, squat, kneel, pivot).Concomitant medications included acetaminophen (acetaminophen) for arthralgia; docusate sodium (colace) for bowel movement irregularity; sodium chloride (sodium chloride); oxycodone (oxycodone); sennoside a+b (senna sennoside a+b); levothyroxine (levothyroxine); meropenem (meropenem); ciprofloxacin (ciprofloxacin); aspirin (acetylsalicylic acid); promethazine (promethazine); dextrose (dextrose); diclofenac sodium (voltaren (diclofenac sodium); rosuvastatin calcium (crestor); colesevelam (colesevelam); cyclosporine (cyclosporine); glyburide (glyburide); phenytoin (phenytoin); ethinylestradiol (ethinylestradiol); norethindrone (norethisterone); warfarin (warfarin); carbamazepine (carbamazepine); digoxin (digoxin); lithium carbonate (lithium carbonate); theophylline (theophylline); doxycycline (vibramycin); acetylsalicylic acid (ecotrin); and tramadol hydrochloride (ultram) on (b)(6) 2018, the patient received treatment with hylan g-f 20, sodium hyaluronate injection in left knee at unknown dose, via intraarticular route once (batch - 7rs027, (b)(6) 2020, strength 16mg/ 2ml) for left knee pain.After local anesthesia, 21 gauge needle was advanced under sonographic guidance to the suprapatellar recess and after sonographic confirmation of the needle tip within the suprapatellar recess, hylan g-f 20, sodium hyaluronate was injected with excellent arthrogram flow.Patient tolerated the procedure well without complications.On (b)(6) 2020, after two days, she developed a large effusion which was quite painful but which progressed to the point where she was having significant difficulty ambulating (intervention required, disability).No systemic symptoms of infection, such as fevers or chills.She had an aspirate done which has 9000 cells, 19 percent pmn, no crystals.Gram stain had a rare gram-negative bacillus but overall culture was negative.Broad range bacterial pcr sequencing on two specimens also detected no bacterial dna.On unknown date in (b)(6) 2018, after few days, left knee was inflamed.On (b)(6) 2018, after latency of 6 days, patient visited clinic because of left knee pain and swelling with slight warmth.She had 3+ effusion and range of motion of 10 to 70 degrees with pain.On same day, left was aspirated and corticosteroid was injected.A syringe of 5 cc of 1% lidocaine was injected into the skin and subcutaneous tissues at the superolateral knee.An 18 gauge needle was utilized to inject a solution of 4 cc of 1% lidocaine and 2 cc of depo-medrol into the left knee joint.The patient experienced immediate relief and was able to range the knee from 0 to 120 degrees without pain.After aspiration of left knee, a pseudo septic reaction was suspected (intervention required, disability).Cell count of the fluid was 9,122 nucleated cells with 19 percent neutrophils (neutrophils low), pain was 4/10, range of motion lacking 5 degrees of extension to 120 degrees of flexion with 1+ effusion and no warmth.On (b)(6) 2018, after 7 days, patient had pain and swelling in left knee,3+ effusion, was slight warmth and range of motion of 10 to 70 degrees with pain.Neutrophil count was 8.27 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5) and leukocyte count 10.8 10*9/l (outside normal range).On (b)(6) 2018, patient was admitted to hospital for left knee arthroplasty irrigation and debridement as patient had left knee pain.There were no complications during or immediately after the procedure and the patient was transferred to the general orthopedic floor postoperatively.However, it was reported that after this surgery, patient became dependent and started using crutches.It was planned to discharge the patient with home infusions for iv antibiotics if needed.On same day, post procedural septic arthritis (medically significant) was suspected in left knee and left knee synovial fluid was removed for more clarifications.On an unknown date in (b)(6) 2018, after few days latency, synovium left knee excision showed proliferative synovitis of left knee with chronic inflammation but no significant acute inflammation.Patient also complained of pain 6/10 when she woke up from sleep, for which she iced her knee.She was unable to bear weight and walk (disability).As of (b)(6) 2018, patient had some pain and discomfort but stated that she was doing well.Neutrophil count was 9.22 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5), glucose random high.On same day, patient had erythema on her face which occurred after the infusion of vancomycin today.Relevant laboratory test results included: magnetic resonance imaging - on (b)(6) 2015: (interval tibial tuberosity transfer with persistent lateral patellar subluxation/tilt, evidence of patellar-lateral femoral condyle friction, and mild progression of patellar chondromalacia with a new infra-articular loose body.) x-ray - in (b)(6) 2016: (left tibial tubercle transfer with screw fixation and lateral subluxation of the left patella.Degenerative changes in the patellofemoral joint.Lateral subluxation of the right patella) action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; unknown for vancomycin corrective treatment: left knee arthroplasty irrigation and debridement surgery crutches user, depomedrol,knee brace and partial synevedomy for pseudoseptic reaction to synvisc; crutch user for unable to bear weight and walk /significant difficulty ambulating; not reported for other events outcome: unknown for all events a product technical complaint (ptc) was initiated on 10-feb-2020 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.The final investigation was completed on 01-mar-2020 with summarized conclusion as no assessment possible.Follow up information was received on 13-feb-2020 from other health professional.Global ptc number added.No significant information was received.Follow information was received on 01-mar-2020 from other health professional.No new information was received.Additional information was received on 01-mar-2020 from other health professional.Global ptc details were added.Text amended accordingly.
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Event Description
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Unable to bear weight and walk /significantdifficulty ambulating [unable to walk] pseudoseptic reaction to synvisc/inflamed left knee [pseudoseptic arthritis] ([effusion (l) knee], [knee pain], [synovitis of knee]) unable to bear weight and walk [weight bearing difficulty] erythema on her face [erythema facial] certainly the neutrophil count is low [neutrophil count low] range of motion is laclang 5 degrees of extension to 120 degrees of flexion [joint range of motion decreased] leukocyte count outside range [white blood cell count abnormal] eosinophil count low [eosinophil count low] had an aspirate done [arthrocentesis] swelling in left knee [swelling of l knee] slight warmth [joint warmth] pain and discomfort [discomfort] case narrative: initial information received on 10-feb-2020 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) female patient who experienced pseudoseptic reaction to synvisc/inflamed left knee (latency few days), aspiration of the left kneeerythema on her face ( latency 8 days), unable to bear weight and walk this morning, unable to bear weight and walk this morning/significant difficulty ambulating and certainly the neutrophil count is low (latency few days), range of motion is lacking 5 degrees of extension to 120 degrees of flexion, eosinophil count low and leukocyte count outside range (latency 7 days) while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one) and vancomycin (vancomycin) the patient's past medical history included dislocation of left patella in high school/patellar subluxations (with patient had a recurrent instability), cholecystectomy (8 years ago), familial hypercholesterolemia , cholestatic liver disease ,worsening pain and instability while going down stairs in 2016, degenerative arthritis on left knee arthroscopy, patellar chondroplasty, intermittent instabilities of her left knee while walking, irritable bowel syndrome, diarrhea predominant ( in 2008), plantar fasciitis, right rotator cuff tendinopathy/achilles tendinopathy, nasal reconstruction, bakers cyst, left knee tibial tubercle anteromedialization on (b)(6) 2016, hospitalized, smaller effusion ( (b)(6) 2015), cosmetic/plastic surgery, breast surgery, ldl remains high at 196, a lot of difficulty with walking (with lack of knee flexion during mid phases of gait deviations), had to go on crutches for a while, internal hemorrhoid (2017)limitation of motion and weakness.Patient had a family history of alcohol abuse (father), 1 daughter deceased and heart disease (grandparents).The patient's past medical treatment(s), vaccination(s) were not provided.At the time of the event, the patient had ongoing graves disease (with currently on levothyroxine for this), tobacco never used, left knee pain, allergies to sulfonamides/sulfa allergy (with rash, breathing difficulty, hives) and patellar pain (with symptoms are improving; frequency of symptoms is constant but intensity varies pain intensity: 8, aggravating factors: twisting, stairs, walking, squat, kneel, pivot).Concomitant medications included acetaminophen (acetaminophen) for arthralgia; docusate sodium (colace) for bowel movement irregularity; sodium chloride (sodium chloride); oxycodone (oxycodone); sennoside a+b (senna sennoside a+b); levothyroxine (levothyroxine); meropenem (meropenem); ciprofloxacin (ciprofloxacin); aspirin (acetylsalicylic acid); promethazine (promethazine); dextrose (dextrose); diclofenac sodium (voltaren (diclofenac sodium); rosuvastatin calcium (crestor); colesevelam (colesevelam); cyclosporine (cyclosporine); glyburide (glyburide); phenytoin (phenytoin); ethinylestradiol (ethinylestradiol); norethindrone (norethisterone); warfarin (warfarin); carbamazepine (carbamazepine); digoxin (digoxin); lithium carbonate (lithium carbonate); theophylline (theophylline); doxycycline (vibramycin); acetylsalicylic acid (ecotrin); and tramadol hydrochloride (ultram) on (b)(6) 2018, the patient received treatment with hylan g-f 20, sodium hyaluronate injection in left knee at unknown dose, via intraarticular route once (batch number, expiry date: unknown strength 16mg/ 2ml) for left knee pain.After local anesthesia, 21 gauge needle was advanced under sonographic guidance to the suprapatellar recess and after sonographic confirmation of the needle tip within the suprapatellar recess, hylan g-f 20, sodium hyaluronate was injected with excellent arthrogram flow.Patient tolerated the procedure well without complications.On (b)(6) 2020, after two days, she developed a large effusion which was quite painful but which progressed to the point where she was having significant difficulty ambulating (intervention required, disability).No systemic symptoms of infection, such as fevers or chills.She had an aspirate done which has 9000 cells, 19 percent pmn, no crystals.Gram stain had a rare gram-negative bacillus but overall culture was negative.Broad range bacterial pcr sequencing on two specimens also detected no bacterial dna.On unknown date in feb 2018, after few days, left knee was inflamed.On (b)(6) 2018, after latency of 6 days, patient visited clinic because of left knee pain and swelling with slight warmth.She had 3+ effusion and range of motion of 10 to 70 degrees with pain.On same day, left was aspirated and corticosteroid was injected.A syringe of 5 cc of 1% lidocaine was injected into the skin and subcutaneous tissues at the superolateral knee.An 18 gauge needle was utilized to inject a solution of 4 cc of 1% lidocaine and 2 cc of depo-medrol into the left knee joint.The patient experienced immediate relief and was able to range the knee from 0 to 120 degrees without pain.After aspiration of left knee (anthrocentensis), a pseudo septic reaction was suspected (intervention required, disability).Cell count of the fluid was 9,122 nucleated cells with 19 percent neutrophils (neutrophils low), pain was 4/10, range of motion lacking 5 degrees of extension to 120 degrees of flexion with 1+ effusion and no warmth.On 07-feb-2018, after 7 days, patient had pain and swelling in left knee,3+ effusion, was slight warmth and range of motion of 10 to 70 degrees with pain.Neutrophil count was 8.27 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5) and leukocyte count 10.8 10*9/l (outside normal range).On (b)(6) 2018, patient was admitted to hospital for left knee arthroplasty irrigation and debridement as patient had left knee pain.There were no complications during or immediately after the procedure and the patient was transferred to the general orthopedic floor postoperatively.However, it was reported that after this surgery, patient became dependent and started using crutches.It was planned to discharge the patient with home infusions for iv antibiotics if needed.On same day, post procedural septic arthritis (medically significant) was suspected in left knee and left knee synovial fluid was removed for more clarifications.On an unknown date in (b)(6) 2018, after few days latency, synovium left knee excision showed proliferative synovitis of left knee with chronic inflammation but no significant acute inflammation.Patient also complained of pain 6/10 when she woke up from sleep, for which she iced her knee.She was unable to bear weight and walk (disability).As of (b)(6) 2018, patient had some pain and discomfort but stated that she was doing well.Neutrophil count was 9.22 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5), glucose random high.On same day, patient had erythema on her face which occurred after the infusion of vancomycin today.Relevant laboratory test results included: magnetic resonance imaging - on (b)(6) 2015: (interval tibial tuberosity transfer with persistent lateral patellar subluxation/tilt, evidence of patellar-lateral femoral condyle friction, and mild progression of patellar chondromalacia with a new infra-articular loose body.) x-ray - in (b)(6) 2016: (left tibial tubercle transfer with screw fixation and lateral subluxation of the left patella.Degenerative changes in the patellofemoral joint.Lateral subluxation of the right patella) action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; unknown for vancomycin corrective treatment: left knee arthroplasty irrigation and debridement surgery crutches user, depomedrol,knee brace and partial synevedomy for pseudoseptic reaction to synvisc; crutch user for unable to bear weight and walk /significant difficulty ambulating; not reported for other events outcome: unknown for all events a product technical complaint (ptc) was initiated on 10-feb-2020 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available: the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa is required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.The final investigation was completed on 20-jul-2022 with summarized conclusion as no assessment possible the complaint (b)(4) for usa has been reopened for the following reason: incomplete complaint information.Follow up information was received on 13-feb-2020 from other health professional.Global ptc number added.No significant information was received.Follow information was received on 01-mar-2020 from other health professional.No new information was received.Additional information was received on 01-mar-2020 from other health professional.Global ptc details were added.Text amended accordingly.Additional information was received on 19-jul-2022 from other health care professional.Ptc reopened.Additional information was received on 20-jul-2022 from the quality department.Ptc details was added.
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Event Description
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Unable to bear weight and walk /significantdifficulty ambulating [unable to walk] pseudoseptic reaction to synvisc [pseudosepsis] ([joint inflammation], [effusion (l) knee], [knee pain], [synovitis of knee], [swelling of l knee], [joint warmth], [discomfort]) erythema on her face [erythema facial] unable to bear weight and walk [weight bearing difficulty] certainly the neutrophil count is low [neutrophil count low] range of motion is laclang 5 degrees of extension to 120 degrees of flexion [joint range of motion decreased] leukocyte count outside range [white blood cell count abnormal] eosinophil count low [eosinophil count low] case narrative: initial information received on 10-feb-2020 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) female patient who experienced pseudoseptic reaction to synvisc (latency few days), erythema on her face ( latency 8 days), unable to bear weight and walk this morning, unable to bear weight and walk this morning/significant difficulty ambulating and certainly the neutrophil count is low (latency few days), range of motion is lacking 5 degrees of extension to 120 degrees of flexion, eosinophil count low and leukocyte count outside range (latency 7 days) while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one) and vancomycin (vancomycin) the patient's past medical history included dislocation of left patella in high school/patellar subluxations (with patient had a recurrent instability), cholecystectomy (8 years ago), familial hypercholesterolemia , cholestatic liver disease ,worsening pain and instability while going down stairs in 2016, degenerative arthritis on left knee arthroscopy, patellar chondroplasty, intermittent instabilities of her left knee while walking, irritable bowel syndrome, diarrhea predominant ( in 2008), plantar fasciitis, right rotator cuff tendinopathy/achilles tendinopathy, nasal reconstruction, bakers cyst, left knee tibial tubercle anteromedialization on (b)(6) 2016, hospitalized, smaller effusion ((b)(6) 2015), cosmetic/plastic surgery, breast surgery, ldl remains high at 196, a lot of difficulty with walking (with lack of knee flexion during mid phases of gait deviations), had to go on crutches for a while, internal hemorrhoid (2017)limitation of motion and weakness.Patient had a family history of alcohol abuse (father), 1 daughter deceased and heart disease (grandparents).The patient's past medical treatment(s), vaccination(s) were not provided.At the time of the event, the patient had ongoing graves disease (with currently on levothyroxine for this), tobacco never used, left knee pain, allergies to sulfonamides/sulfa allergy (with rash, breathing difficulty, hives) and patellar pain (with symptoms are improving; frequency of symptoms is constant but intensity varies pain intensity: 8, aggravating factors: twisting, stairs, walking, squat, kneel, pivot).Concomitant medications included acetaminophen (acetaminophen) for arthralgia; docusate sodium (colace) for bowel movement irregularity; sodium chloride (sodium chloride); oxycodone (oxycodone); sennoside a+b (senna sennoside a+b); levothyroxine (levothyroxine); meropenem (meropenem); ciprofloxacin (ciprofloxacin); aspirin (acetylsalicylic acid); promethazine (promethazine); dextrose (dextrose); diclofenac sodium (voltaren (diclofenac sodium); rosuvastatin calcium (crestor); colesevelam (colesevelam); cyclosporine (cyclosporine); glyburide (glyburide); phenytoin (phenytoin); ethinylestradiol (ethinylestradiol); norethindrone (norethisterone); warfarin (warfarin); carbamazepine (carbamazepine); digoxin (digoxin); lithium carbonate (lithium carbonate); theophylline (theophylline); doxycycline (vibramycin); acetylsalicylic acid (ecotrin); and tramadol hydrochloride (ultram) on (b)(6) 2018, the patient received treatment with hylan g-f 20, sodium hyaluronate injection in left knee at unknown dose, via intraarticular route once (batch - 7rs027, (b)(6) 2020, strength 16mg/ 2ml) for left knee pain.After local anesthesia, 21 gauge needle was advanced under sonographic guidance to the suprapatellar recess and after sonographic confirmation of the needle tip within the suprapatellar recess, hylan g-f 20, sodium hyaluronate was injected with excellent arthrogram flow.Patient tolerated the procedure well without complications.On (b)(6) 2020, after two days, she developed a large effusion which was quite painful but which progressed to the point where she was having significant difficulty ambulating (intervention required, disability).No systemic symptoms of infection, such as fevers or chills.She had an aspirate done which has 9000 cells, 19 percent pmn, no crystals.Gram stain had a rare gram-negative bacillus but overall culture was negative.Broad range bacterial pcr sequencing on two specimens also detected no bacterial dna.On unknown date in (b)(6) 2018, after few days, left knee was inflamed.On (b)(6) 2018, after latency of 6 days, patient visited clinic because of left knee pain and swelling with slight warmth.She had 3+ effusion and range of motion of 10 to 70 degrees with pain.On same day, left was aspirated and corticosteroid was injected.A syringe of 5 cc of 1% lidocaine was injected into the skin and subcutaneous tissues at the superolateral knee.An 18 gauge needle was utilized to inject a solution of 4 cc of 1% lidocaine and 2 cc of depo-medrol into the left knee joint.The patient experienced immediate relief and was able to range the knee from 0 to 120 degrees without pain.After aspiration of left knee, a pseudo septic reaction was suspected (intervention required, disability).Cell count of the fluid was 9,122 nucleated cells with 19 percent neutrophils (neutrophils low), pain was 4/10, range of motion lacking 5 degrees of extension to 120 degrees of flexion with 1+ effusion and no warmth.On (b)(6) 2018, after 7 days, patient had pain and swelling in left knee,3+ effusion, was slight warmth and range of motion of 10 to 70 degrees with pain.Neutrophil count was 8.27 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5) and leukocyte count 10.8 10*9/l (outside normal range).On (b)(6) 2018, patient was admitted to hospital for left knee arthroplasty irrigation and debridement as patient had left knee pain.There were no complications during or immediately after the procedure and the patient was transferred to the general orthopedic floor postoperatively.However, it was reported that after this surgery, patient became dependent and started using crutches.It was planned to discharge the patient with home infusions for iv antibiotics if needed.On same day, post procedural septic arthritis (medically significant) was suspected in left knee and left knee synovial fluid was removed for more clarifications.On an unknown date in (b)(6) 2018, after few days latency, synovium left knee excision showed proliferative synovitis of left knee with chronic inflammation but no significant acute inflammation.Patient also complained of pain 6/10 when she woke up from sleep, for which she iced her knee.She was unable to bear weight and walk (disability).As of 08-feb-2018, patient had some pain and discomfort but stated that she was doing well.Neutrophil count was 9.22 10*9/l (high, ref: 2.70-7), eosinophil count <0.03 (low, ref: 0.05-0.5), glucose random high.On same day, patient had erythema on her face which occurred after the infusion of vancomycin today.Relevant laboratory test results included: magnetic resonance imaging - on (b)(6) 2015: (interval tibial tuberosity transfer with persistent lateral patellar subluxation/tilt, evidence of patellar-lateral femoral condyle friction, and mild progression of patellar chondromalacia with a new infra-articular loose body.) x-ray - in (b)(6) 2016: (left tibial tubercle transfer with screw fixation and lateral subluxation of the left patella.Degenerative changes in the patellofemoral joint.Lateral subluxation of the right patella) action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; unknown for vancomycin corrective treatment: left knee arthroplasty irrigation and debridement surgery crutches user, depomedrol,knee brace and partial synevedomy for pseudoseptic reaction to synvisc; crutch user for unable to bear weight and walk /significant difficulty ambulating; not reported for other events outcome: unknown for all events a product technical complaint (ptc) was initiated on 10-feb-2020 for synvisc one (lot/batch number: 7rs027) with global ptc number: (b)(4).The sample status of the ptc was not available.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.The final investigation was completed on 01-mar-2020 with summarized conclusion as no assessment possible.The complaint (b)(4) for usa has been reopened for the following reason: incomplete complaint information.Follow up information was received on 13-feb-2020 from other health professional.Global ptc number added.No significant information was received.Follow information was received on 01-mar-2020 from other health professional.No new information was received.Additional information was received on 01-mar-2020 from other health professional.Global ptc details were added.Text amended accordingly.Additional information was received on 19-jul-2022 from other health care professional.Ptc reopened.
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