This unsolicited case from united states was received on 02-jan-2018 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and later on the same day, was unable to bend right knee, increased pain, increased swelling and after unknown latency had elevated pancreatic enzymes.Also device malfunction was identified for the reported lot number.The patient had past treatment with several injections of synvisc one.The patient had medical history of knee pain (pain on a scale of 1-10 before the injection) and concurrent conditions include slightly high blood pressure (patient takes a low dose antihypertensive medication).The patient did not have any prosthetic device.The patient had no previous/concomitant treatment with immunosuppressant's.The patient had no allergy to avian proteins, feathers, or egg products.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/lot number: 7rsl021 and expiry date: unknown) into both the knees.The package was opened in room with patient before injection was given.The solution was prepared for disinfection.No medications were injected into the knee joint at the same time as synvisc one.The patient was admitted to hospital related to her being injected for 1 day.It was reported that the patient did not engage in activities such as jogging or tennis soon after the injection.The same day, the patient was unable to bend right knee at the time of hospitalization.Blood work was done in the hospital (results unknown).The same day, the patient had increased pain and swelling.It was reported that the patient was able to bear weight prior to injection and afterwards.No additional support was needed.The patient had pain on a scale of 4-5 and on scale of 1-10 pain was a 10 after injection.The patient did not have fever.On an unknown date, after unknown latency, the patient had elevated pancreatic enzymes (results unknown) which returned to normal after one day.It was reported that it took one week for the patient to recover.It was reported that the patient still had pain after discharge from hospital but not as severe.It was reported that the pain had returned as of 2 weeks after the injection and it was rated as 4-5 sometimes 7 on a scale of 1-10.Corrective treatment: unspecified medication for increased pain; not reported for rest of the events outcome: unknown for elevated pancreatic enzymes; recovered for increased swelling and unable to bend right knee; recovering for device malfunction, increased pain an investigation was initiated as a result of an unexpected increase in the number of labelled 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: hospitalization/prolongation for unable to bend right knee, increased pain, increased swelling and device malfunction.Pharmacovigilance comment: sanofi company comment dated 09-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot for osteoarthritis and was hospitalized as she was unable to her right knee and had increased pain and swelling.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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Unable to bend right knee [joint range of motion decreased] upper abdominal pain/epigastric pain [upper abdominal pain] ([vomiting], [nausea]) acute pancreatitis [acute pancreatitis] device malfunction [device malfunction] increased pain/ pain in right knee/bilateral knee pain/severe pain [knee pain] ([condition aggravated]) increased swelling [swelling of r knee] elevated pancreatic enzymes [pancreatic enzymes increased] blood pressure abnormal [blood pressure abnormal] radiates to right leg pain [leg pain] nausea [nausea] sgot abnormal [sgot increased] elevtaed lipase [lipase increased] absolute neutrophil count high [absolute neutrophil count increased] red blood cell count low [red blood cell count low] white blood cell high [white blood cell count increased] lf shoulder pain that goes to lt lateral knee [radiating pain] feels like when arm is elevated and extended that it catches [arm discomfort] glucose high [glucose high] potassium low [potassium low] case narrative: based on the information received on 09-aug-2018, the case become medically confirmed.This unsolicited case from united states was received on 02-jan-2018 from a patient.This case concerns a 55 year old female patient who received treatment with synvisc one and later on the same day, was unable to bend right knee, increased pain/ pain in right knee/ bilateral knee pain/severe pain, increased swelling and after unknown latency had elevated pancreatic enzymes, acute pancreatitis, blood pressure abnormal, radiates to right leg pain, nausea, sgot abnormal, elevated lipase, absolute neutrophil count high, red blood cell high, white blood cell high (latency: 1 day), potassium low potassium low, glucose high, glucose high (latency: 9 days), lt shoulder pain that goes to lt lateral knee (latency: unknown) and feels like when arm is elevated and extended that it catches (latency: unknown).Also device malfunction was identified for the reported lot number.The patient had past treatment with several injections of synvisc one.The patient had medical history of knee pain (pain on a scale of 1-10 before the injection), chronic sinusitis, epigastric pain, hematochezia, hypertension, high cholesterol, lower back pain and hip pain.Patient reported that she has had lower back pain and hip pain since the past year and it gets worse with prolonged standing and walking.Patient had an influenza vaccine in (b)(6) 2013.The patient's family history included heart disease (father and mother), neoplasm (father) and congestive heart failure (brother) and cancer of colon.Patient's past surgical history included surgical history of colonoscopy on 05-oct-2016, appendectomy in 1990 and hysterectomy in 1991 and concurrent conditions include slightly high blood pressure (patient takes a low dose antihypertensive medication).The patient did not have any prosthetic device.The patient concomitant medication included citalopram (citalopram), meloxicam (meloxicam), hydrochlorothiazide (hydrochlorothiazide), omeprazole (protonix), trazodone (trazodone), magnesium oxide (magnesium oxide) and escitalopram oxalate (lexapro).The patient had no allergy to avian proteins, feathers, or egg products.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for bilateral primary osteoarthritis both knees (batch/lot number: 7rsl021 and expiry date: unknown) into both the knees.The package was opened in room with patient before injection was given.The solution was prepared for disinfection.No medications were injected into the knee joint at the same time as synvisc one.The patient was admitted to hospital related to her being injected for 1 day.It was reported that the patient did not engage in activities such as jogging or tennis soon after the injection.The same day, the patient was unable to bend right knee at the time of hospitalization.Blood work was done in the hospital (results unknown).The same day, the patient had increased pain and swelling.It was reported that the patient was able to bear weight prior to injection and afterwards.No additional support was needed.The patient had pain on a scale of 4-5 and on scale of 1-10 pain was a 10 after injection.The patient did not have fever.On an unknown date, after unknown latency, the patient had elevated pancreatic enzymes (results unknown) which returned to normal after one day.It was reported that it took one week for the patient to recover.It was reported that the patient still had pain after discharge from hospital but not as severe.It was reported that the pain had returned as of 2 weeks after the injection and it was rated as 4-5 sometimes 7 on a scale of 1-10.On 21-nov-2017, patient experienced acute pancreatitis for which she was hospitalized.On the same day, while monitoring the body vitals of patient blood pressure abnormal was observed.On the same day, patient experienced the more worsened pain that radiates to right leg pain.On the same day patient experienced nausea.On (b)(6) 2017, while carrying out lab test sgot abnormal was observed in patient.While conducting the lab of patient elevated lipase was observed in him.On the same day, she experienced absolute neutrophil count high.On the same day, the white blood cell high was detected in patient.On 21-nov-2017, the patient suffered from red blood cell count low.On (b)(6) 2017, patient underwent labs and lab results of amylase were >3000, sgot were 59 u/l (high) (15-37), blood pressure was abnormal, lipase was 3013 u/l (high) (73-393), absolute neutrophil count was 7.4 x10e3 (high) (2.2-4.8), red blood cells count was 4.12 x10e6 (low) (4.2-5.4) and white blood cell count 11.1 x 10e3 (high) (4.8-10.8).On (b)(6) 2017, patient reported to the clinic and developed epigastric pain.Patient stated that she has had problem with heart burn since last 6 months.The same day after going home, the patient had some nausea and vomiting.On the same day, patient had lab tests done which revealed, potassium was 2.9 mmol/l (ref range: 3.5-5.1) (low) potassium low, glucose high and glucose was 119 (ref range: 74-106mg/dl) potassium low, glucose high.On (b)(6) 2018, patient reported she had bilateral knee pain, which is worse with bending, prolonged sitting to standing and stair climbing.She further reported she had lt shoulder pain that goes to lt lateral knee (latency: unknown) and feels like when arm is elevated and extended that it catches (latency: unknown).Corrective treatment: solumedrol, ibuprofen, fentanyl, morphine, zofran, reglan, toradol, motrin for increased pain/ pain in right knee/ bilateral knee pain/severe pain; not reported for rest of the events outcome: unknown for elevated pancreatic enzymes, acute pancreatitis, blood pressure abnormal, radiates to right leg pain, nausea, sgot abnormal, elevated lipase, absolute neutrophil count high, red blood cell count low and white blood cell high ; recovered for increased swelling and unable to bend right knee; recovering for device malfunction, increased pain; unknown for lt shoulder pain that goes to lt lateral knee and feels like when arm is elevated and extended that it catches a pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: hospitalization/prolongation for unable to bend right knee, increased pain/ pain in right knee, increased swelling, device malfunction and acute pancreatitis; intervention required for increased pain/ pain in right knee and device malfunction follow up received on 31-jan-2018.Global ptc number was added.Additional information was received on 09-aug-2018 from physician.Concomitant medications were added.Corrective treatment for increased pain/ pain in right knee were added.Events of blood pressure abnormal, acute pancreatitis, radiates to right leg pain, sgot abnormal, elevated lipase, red blood cell count low and white blood cell high were added.Clinical course updated.Text amended accordingly.Additional information received on 09-aug-2018 from physician.Medical history of chronic sinusitis, epigastric pain, hematochezia, hypertension, high cholesterol, lower back pain and hip pain.Surgical history of colonoscopy, appendectomy and hysterectomy added.Patient's previous vaccination schedule added.Family history of heart failure, neoplasm, congestive heart failure, cancer of colon added with details.Events of potassium low, glucose high, lt shoulder pain that goes to lt lateral knee and feels like when arm is elevated and extended that it catches added and events of nausea, vomiting added as symptoms of upper abdominal pain/epigastric pain.Event verbatim updated for increased pain/ pain in right knee were added to increased pain/ pain in right knee/ bilateral knee pain/severe pain.Clinical course updated.Text amended accordingly.
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