| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Fatigue (1849); Synovitis (2094); Arthralgia (2355); Joint Swelling (2356); Depression (2361); Joint Disorder (2373); Sleep Dysfunction (2517); No Code Available (3191)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case was received from unites states on 22-jan-2018 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after few hours developed pain with every step that he takes, he walks as if he is a 70 year-old man, his knees were beyond in pain/still had pain and sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn.Also, device malfunction was identified for the reported lot number.Before receiving the product, patient had pain only after running or activity.No past drug, concomitant medications and concurrent conditions were reported.On an unknown date in (b)(6) 2017, the patient initiated treatment with intra- articular synvisc one injection at a dose of 6 ml once (batch/lot no.: 7rsl021 and expiration date: not provided) for bilateral knee osteoarthritis.The same night, few hours after receiving the injections, patient's knees were beyond in pain.They sucked out 70 or 80 cc from his right knee and 40 to 60 cc from his left knee.They have continued to suck out stuff from his knees.He went to the er.Patient was fine before the injections, but now my knees were worse.On an unspecified date in (b)(6) 2017, few hours after the injection, patient had pain with every step that he took and he walked as if he was a 70 year-old man.He was informed by his physician that he received the recalled lot in each of his knees.He was the founder of largest charity boxing event in the country and had to get through the event after receiving the injections.In order to get through the charity boxing event, he had fluid drawn, cortisone injection, and knee braces.He still had pain.Corrective treatment: not reported for device malfunction; fluid drawn, cortisone injection and knee braces for sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn; cortisone injection and knee braces for rest of the events.Outcome: not recovered for all the events.Seriousness criteria: required intervention for all.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment dated 27-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain with walking and difficulty walking.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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This unsolicited case was received from unites states on 22-jan-2018 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after few hours developed pain with every step that he takes, he walks as if he is a 70 year-old man, his knees were beyond in pain/still had pain and sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn.Also, device malfunction was identified for the reported lot number.Before receiving the product, patient had pain only after running or activity.No past drug, concomitant medications and concurrent conditions were reported.On an unknown date in (b)(6) 2017, the patient initiated treatment with intra- articular synvisc one injection at a dose of 6 ml once (batch/lot no.: 7rsl021 and expiration date: not provided) for bilateral knee osteoarthritis.The same night, few hours after receiving the injections, patient's knees were beyond in pain.They sucked out 70 or 80 cc from his right knee and 40 to 60 cc from his left knee.They have continued to suck out stuff from his knees.He went to the er.Patient was fine before the injections, but now my knees were worse.On an unspecified date in (b)(6) 2017, few hours after the injection, patient had pain with every step that he took and he walked as if he was a 70 year-old man.He was informed by his physician that he received the recalled lot in each of his knees.He was the founder of largest charity boxing event in the country and had to get through the event after receiving the injections.In order to get through the charity boxing event, he had fluid drawn, cortisone injection, and knee braces.He still had pain.Corrective treatment: not reported for device malfunction; fluid drawn, cortisone injection and knee braces for sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn; cortisone injection and knee braces for rest of the events outcome: not recovered for all the events seriousness criteria: required intervention for all a global pharmaceutical technical complaint (ptc) number is 52274.An investigation was initiated as a result of an unexpected increase in the number of labeled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions will be implemented.Additional information was received on 06-feb-2018.Global ptc number and investigation summary was added.Pharmacovigilance comment: sanofi company comment for follow up dated 6-feb-2018: the follow up information received does not change previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain with walking and difficulty walking.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction] pain with every step that he takes [musculoskeletal pain] severe tri-compartmental degenerative joint disease [degenerative joint disease] ([knee pain], [condition worsened], [knee effusion], [joint stiffness], [joint swelling], [difficulty in walking]) constipation [constipation] depression [depression] sleep disturbances [sleep disturbance] weight gain [weight gain] muscle weakness [muscle weakness] affecting his activities of daily living [activities of daily living impaired] feeling weak [feelings of weakness] feeling tired [tiredness] synovitis [synovitis].Case narrative: based on additional information received on 19-feb-2019 from a health care professional, the case was medically confirmed.This unsolicited case was received from united states on 22-jan-2018 from a patient.This case concerns a 49 year old male patient who received treatment with synvisc one injection and after few hours developed pain with every step that he takes, after unknown latency had severe tri-compartmental degenerative joint disease, feeling tired, constipation, depression, feeling weak, sleep disturbances, weight gain, muscle weakness, affecting his activities of daily living, synovitis.Also, device malfunction was identified for the reported lot number.Before receiving the product, patient had pain only after running or activity.Medical history included diverticulosis, asthma.Patient was a non-smoker, used alcohol occasionally and did not used illicit drugs.Family history included arthritis in mother.Patient had no known drug allergies.Concomitant medications included alprazolam; amfetamine sulfate (amphetamine salts); anastrozole; azelastine hcl; azithromycin; benzonatate; tadalafil (cialis); doxycycline monohydrate; fluticasone propionate fluticasone propionate; oxycodone hydrochloride, paracetamol (oxycodone and acetaminophen); prednisone; promethazine hcl; rabeprazole sodium; tamsulosin hcl; valaciclovir hydrochloride; salbutamol sulfate (ventolin hfa); and sildenafil citrate (viagra).On an unknown date in (b)(6) 2017, the patient initiated treatment with intra- articular synvisc one injection at a dose of 6 ml once (batch/lot no.: 7rsl021 and expiration date: not provided) for bilateral knee osteoarthritis.The same night, few hours after receiving the injections, patient's knees were beyond in pain.They sucked out 70 or 80 cc from his right knee and 40 to 60 cc from his left knee.They have continued to suck out stuff from his knees.He went to the er.Patient was fine before the injections, but now my knees were worse.On an unspecified date in (b)(6) 2017, few hours after the injection, patient had pain with every step that he took and he walked as if he was a 70 year-old man.He was informed by his physician that he received the recalled lot in each of his knees.He was the founder of largest charity boxing event in the country and had to get through the event after receiving the injections.In order to get through the charity boxing event, he had fluid drawn, cortisone injection, and knee braces.He still had pain.As of (b)(6) 2018, patient was feeling tired, had constipation, joint pain, depression, feeling weak, joint stiffness, joint swelling, sleep disturbances, recent weight gain and muscle weakness.On (b)(6) 2018, patient presented with severe and debilitating right and left knee pain affecting his activities of daily living.Patient had multiple courses of physical therapy, cortisone, took anti-inflammatory advil and had tried patches all without relief.On an unknown date, patient had difficulty standing and walking for long periods of time.Patient felt that the right knee was worse than left and patient would like to seek definitive procedure.The symptoms were worsening and the current pain level was 10/10 (average pain level: 8/10, minimum pain level: 7/10, maximum pain level: 10/10).Patient's symptoms occur while walking, standing, sitting and lifting and symptoms seemed to be occurring daily.The symptoms were worsened by bending, running, direct pressure, knee flexion and knee extension.Relieving factors included acetaminophen, exercise regimen, ice, rest, non-steroidal anti-inflammatory drugs, opioid analgesics.Patient was still having left and right knee pain (unspecified chronicity).On the same day, imaging showed severe tri-compartmental degenerative joint disease (djd) to the tight and left knee with multiple subchondral cysts, periarticular osteophytes, bone on bone contact medial femoral tibia compartments and patellofemoral joints bilaterally.The patient was advised total knee arthroplasty as a treatment option for severe arthritis of right and left knee.On (b)(6) 2018, patient had bilateral knee replacement without lateral release of patella.Intraoperative findings included medium joint effusion and synovitis.On (b)(6) 2018, patient visited for evaluation of both knees.Patient was doing well and was slowly returning back to his previous activities.Patient's current symptoms included constipation and was prescribed colace, but no chills, no diarrhea, fever, dysuria, nausea and vomitting.Patient had some diffuse mild post operative tenderness.Also reported that patient had excellent pain control and no signs of infection.Corrective treatment: not reported for device malfunction; fluid drawn, cortisone injection, physical therapy, advil and knee braces for sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn; cortisone injection, physical therapy, advil and knee braces for pain with every step that he takes for my knees were beyond in pain/still had pain/joint pain, cortisone injection, physical therapy, advil for joint stiffness, joint swelling, not reported for other events outcome: unknown for feeling tired, constipation, depression, feeling weak, sleep disturbances, weight gain, muscle weakness, affecting his activities of daily living, synovitis; not recovered for other events.Seriousness criteria: required intervention for device malfunction, pain with every step that he takes; hospitalization, required intervention and hospitalization for severe tri-compartmental degenerative joint disease a global pharmaceutical technical complaint (ptc) number is (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions will be implemented.Additional information was received on 06-feb-2018.Global ptc number and investigation summary was added.Follow up information received on 02-oct-2018.No new information was received.Additional information was received on 19-feb-2019 from a health care professional.The case was medically confirmed.Patient's medical history and concomitant medications were added.Additional events of severe tri-compartmental degenerative joint disease, feeling tired, constipation, depression, feeling weak, sleep disturbances, weight gain, muscle weakness, affecting his activities of daily living, synovitis were added along with details.The events walks as if he is a 70 year-old man/ difficulty standing and walking for long periods of time, my knees were beyond in pain/still had pain/joint pain and sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn were updated as symptom of severe tri-compartmental degenerative joint disease.Information about total knee replacement was added.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] pain with every step that he takes [pain upon movement] chondral necrosis [avascular necrosis] severe tri-compartmental degenerative joint disease/osteoarthritis severely accelerated [osteoarthritis aggravated] ([knee pain], [condition worsened], [knee effusion], [joint stiffness], [joint swelling], [difficulty in walking]) constipation [constipation] depression [depression] sleep disturbances [sleep disturbance] weight gain [weight gain] muscle weakness [muscle weakness] affecting his activities of daily living [activities of daily living impaired] feeling weak [feelings of weakness] feeling tired [tiredness] mean corpuscular volume low [mean cell volume low] red cell distribution width high [red cell distribution width increased] monocytes high [monocyte count increased] vitamin d 25-hydroxy total low [blood 25-hydroxy vitamin d2 decreased] myalgias [myalgia] chills [chills] sinus pressure [sinus pressure] cough [cough] wheezing [wheezing] voice change [voice alteration] synovitis [synovitis].Case narrative: based on additional information received on 19-feb-2019 from a health care professional, the case was medically confirmed.This unsolicited legal case was received from united states on 22-jan-2018 from a patient.This case concerns a 49 year old male patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) injection and after few hours developed pain with every step that he takes, after unknown latency had severe tri-compartmental degenerative joint disease/osteoarthritis severely accelerated, feeling tired, constipation, depression, feeling weak, sleep disturbances, weight gain, muscle weakness, affecting his activities of daily living, synovitis, myalgias, chills, sinus pressure, cough, wheezing, voice change, chondral necrosis (latency: unknown), mean corpuscular volume low, red cell distribution width high, monocytes high, vitamin d 25-hydroxy total low (latency: 8 months 11 days).Also, device malfunction was identified for the reported lot number.Before receiving the product, patient had pain only after running or activity.Medical history included diverticulosis for which patient had abscess perforation in (b)(6) 2016, colostomy bag sigoid resection in (b)(6) 2016 and then reversal of colostomy in 2017, asthma, anxiety, chicken pox, gastrooesophageal reflux disease, sleep apnea, skin lipoma, shoulder pain, peritoneal abscess, fatigue, dyspnea, nausea, vomiting, diarrhea, abdominal pain after the colostomy, sexual difficulties, joint pains, restriction of motion, muscular weakness, nervousness, difficulty concentrating, knee pain swelling, constipation, backache and alkaline phosphatase and hematocrit low ((b)(6) 2017).Patient was a non-smoker, denied alcohol use and did not used illicit drugs.Family history included arthritis in mother.Patient had no known drug allergies.Patient's concurrent conditions included high cholesterol (hdl, ldl, non-hdl), high triglycerides, low hemoglobin, low mean cell hemoglobin, low mean cell hemoglobin concentration, high estradiol, high testosterone.Concomitant medications included alprazolam; amfetamine sulfate (amphetamine salts); anastrozole; azelastine hcl; azithromycin; benzonatate; tadalafil (cialis); doxycycline monohydrate; fluticasone propionate fluticasone propionate; oxycodone hydrochloride, paracetamol (oxycodone and acetaminophen); prednisone; promethazine hcl; rabeprazole sodium; tamsulosin hcl; valaciclovir hydrochloride; salbutamol sulfate (ventolin hfa); and sildenafil citrate (viagra).On (b)(6) 2017, the patient initiated treatment with intra- articular hylan g-f 20, sodium hyaluronate injection at a dose of 6 ml once (batch/lot no: 7rsl021 and expiration date: not provided) for bilateral knee osteoarthritis.The same night, few hours after receiving the injections, patient's knees were beyond in pain.They sucked out 70 or 80 cc from his right knee and 40 to 60 cc from his left knee.They have continued to suck out stuff from his knees.He went to the er.Patient was fine before the injections, but now the knees were worse.On (b)(6) 2017, few hours after the injection, patient had pain with every step that he took and he walked as if he was a 70 year-old man.He was informed by his physician that he received the recalled lot in each of his knees.He was the founder of largest charity boxing event in the country and had to get through the event after receiving the injections.In order to get through the charity boxing event, he had fluid drawn, cortisone injection, and knee braces.He still had pain.On (b)(6) 2018, patient's laboratory test showed that vitamin d 25-hydroxy total was 23 ng/ml (low, reference range: 30-100 ng/ml), mean corpuscular volume was 74.9 fl (low; reference range: 80-100 fl), monocyte absolute were 963 cell/ul (high; reference range: 200-950 cells/ul) and red cell distribution width was 17.4% (high; reference range: 11.0-15.0 %) (latency: 8 months 11 days).On the same day, patient was positive for fatigue, abdominal pain, arthralgias, back pain, gait problems, joint swelling, myalgia, decreased concentration and had difficulty walking and climbing up exam step, had complains of chills, was positive for sinus pressure, voice change, cough, wheezing (onset and latency: unknown).Both knees were injected with triamcinolone acetonide (kenalog) and lidocaine.As of (b)(6) 2018, patient was feeling tired, had constipation, joint pain, depression, feeling weak, joint stiffness, joint swelling, sleep disturbances, recent weight gain and muscle weakness.On (b)(6) 2018, patient presented with severe and debilitating right and left knee pain affecting his activities of daily living.Patient had multiple courses of physical therapy, cortisone, took anti-inflammatory advil and had tried patches all without relief.On an unknown date, patient had difficulty standing and walking for long periods of time.Patient felt that the right knee was worse than left and patient would like to seek definitive procedure.The symptoms were worsening and the current pain level was 10/10 (average pain level: 8/10, minimum pain level: 7/10, maximum pain level: 10/10).Patient's symptoms occur while walking, standing, sitting and lifting and symptoms seemed to be occurring daily.The symptoms were worsened by bending, running, direct pressure, knee flexion and knee extension.Relieving factors included acetaminophen, exercise regimen, ice, rest, non-steroidal anti-inflammatory drugs, opioid analgesics.Patient was still having left and right knee pain (unspecified chronicity).On the same day, imaging showed severe tri-compartmental degenerative joint disease (djd) to the right and left knee with multiple subchondral cysts, periarticular osteophytes, bone on bone contact medial femoral tibia compartments and patellofemoral joints bilaterally.The patient was advised total knee arthroplasty as a treatment option for severe arthritis of right and left knee.Patient's osteoarthritis was severely accelerated following the hylan g-f 20, sodium hyaluronate injections as patient had severe reaction to them and both knees were aspirated.Patient continued to have significant pain post injection and x-rays revealed severe acceleration and complete obliteration, developed chondral necrosis and patient ultimately had no choice but undergo total knee replacements.On (b)(6) 2018, patient had bilateral knee replacement without lateral release of patella.Intraoperative findings included medium joint effusion and synovitis.On (b)(6) 2018, patient visited for evaluation of both knees.Patient was doing well and was slowly returning back to his previous activities.Patient's current symptoms included constipation and was prescribed colace, but no chills, no diarrhea, fever, dysuria, nausea and vomiting.Patient had some diffuse mild post-operative tenderness.Also reported that patient had excellent pain control and no signs of infection.On (b)(6) 2019, patient had diffuse tenderness, mild effusion bilaterally.Corrective treatment: not reported for device malfunction; fluid drawn, triamcinolone acetonide, lidocaine, cortisone, total knee replacement for severe tri-compartmental degenerative joint disease/osteoarthritis severely accelerated, cortisone injection and knee braces, physical therapy, ibuprofen (advil) for pain with every step that he takes, docusate sodium (colace) for constipation, total knee replacement for chondral necrosis, not reported for other events outcome: not recovered for device malfunction, pain with every step that he takes, unknown for rest seriousness criteria: required intervention for device malfunction, pain with every step that he takes; hospitalization, required intervention and hospitalization for severe tri-compartmental degenerative joint disease, medically significant and required intervention for chondral necrosis.A global pharmaceutical technical complaint (ptc) number is (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions will be implemented.Additional information was received on 06-feb-2018.Global ptc number and investigation summary was added.Follow up information received on 02-oct-2018.No new information was received.Additional information was received on 19-feb-2019 from a health care professional.The case was medically confirmed.Patient's medical history and concomitant medications were added.Additional events of severe tri-compartmental degenerative joint disease, feeling tired, constipation, depression, feeling weak, sleep disturbances, weight gain, muscle weakness, affecting his activities of daily living, synovitis were added along with details.The events walks as if he is a 70 year-old man/ difficulty standing and walking for long periods of time, my knees were beyond in pain/still had pain/joint pain and sucked out 70 or 80 cc from my right knee and 40 to 60 cc from my left knee/fluid drawn were updated as symptom of severe tri-compartmental degenerative joint disease.Information about total knee replacement was added.Clinical course was updated and text was amended accordingly.Additional information was received on 15-mar-2019 from lawyer.Medical history updated.Therapy dates updated for the suspect.Events of mean corpuscular volume low, voice change, red cell distribution width high, monocytes high, vitamin d 25-hydroxy total low, chondral necrosis, myalgias, chills, sinus pressure, cough, wheezing were added with details.Verbatim of event severe tri-compartmental degenerative joint disease was updated to severe tri-compartmental degenerative joint disease/osteoarthritis severely accelerated and corrective treatment updated for the same.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.
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