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Restricted motion [mobility decreased] ; weightbearing with a walker [weight bearing difficulty] ; pain aggravated by movement and walking/pain with ambulation [pain upon movement] ; pain aggravated by bending [joint range of motion decreased] ; red right knee/redness [injection site redness] ; very painful right knee/right knee pain/knee tenderness/increased pain [knee pain] ; swollen right knee/ swelling over the lateral supra patella pouch of the right knee [swelling of r knee] ; aspirated 80 ml of cloudy fluid [knee effusion] ; warmth of right knee [joint warmth] / case narrative: based on additional information received on (b)(6) 2018, this case initially considered as non-serious was upgraded to serious as the serious event of weight bearing with a walker was added with disability as seriousness criteria, restricted motion, pain aggravated by movement and walking/pain with ambulation, pain aggravated by bending were added with seriousness criteria as required intervention.Also, the events of red right knee, very painful right knee/right knee pain/knee tenderness and swollen right knee/ swelling over the lateral supra patella pouch of the right knee were upgraded to serious with seriousness criteria as required intervention.Also, the suspect product was updated form synvisc to synvisc one.Reporter causality was also updated from not reported to related.This unsolicited case from united states was received on (b)(6) 2018 from a nurse.This case concerns an elderly (b)(6) male patient who received treatment with synvisc one injection and on the same day had red right knee, swollen right knee/ swelling over the lateral supra patella pouch of the right knee, very painful right knee/right knee pain/ knee tenderness, after 1 day had aspirated 80 ml of cloudy fluid and had warmth of right knee; after unknown latency had restricted motion, was weightbearing with a walker, pain aggravated by movement and walking/pain with ambulation, pain aggravated by bending.Medical history included lumbar pain and right knee pain since (b)(6) 2016, hypertension, spinal stenosis, primary osteoarthritis of right ankle (since (b)(6) 2016) and right knee; effusion of right (since (b)(6) 2016), prepatellar bursa, gout and lumbar radiculopathy ((b)(6) 2016), arthritis and smoker (cigarette and pipe).Concomitant medications included metoprolol tartrate, warfarin, tramadol, tamsulosin, prednisone, simvastatin, metformin, lisinopril, finasteride and amlodipine.Patient had no known allergies.There was no history of alcohol use.The patient did not use caffeine.The patient was not at risk for falls.The patient had not fallen in the last year.Patient's family history included osteoarthritis and arthritis in father and mother and migraines in mother.On (b)(6) 2018, the patient received treatment with intra- articular synvisc one injection (dose and frequency: unknown) (batch/lot number: 7rsl044; expiration date: 31-oct-2020) for osteoarthritis of right knee.After the shot, patient felt well.Patient walked a little bit and was hoping to get up and go out, but he woke up at night with severe pain and swelling of his knee, slight warmth, but no obvious erythema on the same day.It was reported that the patient started having pain throughout the night that was sharp and he could not get comfortable.Patient had pain with moving and walking on an unknown date in (b)(6) 2018.The pain was deep discomfort.The pain was aggravated by bending, movement and walking (pain on pain scale: 5/10) (onset date: (b)(6) 2018).The pain was relieved by ice and rest.Pertinent negatives included numbness and tingling in the legs.Patient called the office and was told to use ice.On the same day, patient had redness in right knee.On (b)(6) 2018, patient presented to the office after using ice and was starting to feel a little bit better, but he was using a rolling walker.On the same day, patient's pain on pain scale was 7/10.On the same day, in morning, patient had some warmth of his right knee.It was reported that the patient still had tenderness and still was not back to his normal activities.Patient still had some swelling over the lateral supra patella pouch of the right knee.Severity level was 7.Patient was feeling better as compared to last night.Patient was weight bearing with a walker (onset date: 2018; latency: unknown).On the same day, patient had physical exam.There was no erythema and no obvious warmth.Patient had moderate swelling in right knee and some pain with ambulation and restricted motion (onset date: (b)(6) 2018).On the same day, patient had arthrocentesis of major joint.Site was prepped using sterile technique.Right knee lateral suprapatellar pouch aspiration and injection was performed with lidocaine 1% plain for anesthetic.Placement confirmed by manual palpation.88 ml of non-inflammatory fluid was withdrawn.It was reported that betamethasone acetate and sodium phosphate (celestone) 6 mg (ls ml) was injected.A sterile pressure dressing was applied.A sterile adhesive dressing was applied.Patient elected to proceed with aspiration and cortisone injection because of the pain.The patient tolerated the treatment well.Fluid was sent for analysis.Corrective treatment: cortisone shot, betamethasone acetate and sodium phosphate and aspiration for restricted motion, red right knee; rolling walker for weightbearing with a walker, ice, cortisone shot, betamethasone acetate and sodium phosphate and aspiration for swollen right knee/ swelling over the lateral supra patella pouch of the right knee, very painful right knee/right knee pain/knee tenderness, pain aggravated by bending, pain aggravated by movement and walking/pain with ambulation, ice for warmth of right knee and not reported for other events outcome: recovered for red right knee, swollen right knee/ swelling over the lateral supra patella pouch of the right knee and very painful right knee/right knee pain/knee tenderness, warmth of right knee; unknown for other events a product technical complaint was initiated on 24-apr-2018 for synvisc one, batch number: 7rsl044, global ptc number (b)(4) the production and quality control documentation for lot # 7rsl044 expiration date (2020-10-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl044 no capa is required.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 if a capa is still required reporter's causality: related for all events seriousness criteria: required intervention for restricted motion, red right knee, swollen right knee/ swelling over the lateral supra patella pouch of the right knee, very painful right knee/right knee pain/knee tenderness, pain aggravated by bending, pain aggravated by movement and walking/pain with ambulation and disability for weight bearing with a walker additional information was received on 24-apr-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 29-may-2018 from a health care professional.The case was upgraded to serious.Suspect product was updated from synvisc to synvisc one.Patient's medical history, family history and concomitant medications were added.Additional events of warmth of right knee, aspirated 80 ml of cloudy fluid, weight bearing with a walker, restricted motion, pain aggravated by movement and walking/pain with ambulation, pain aggravated by bending were added along with details.The event term swollen right knee was updated to swollen right knee/ swelling over the lateral supra patella pouch of the right knee, very painful right knee was updated to very painful right knee/right knee pain/knee tenderness.Event onset date and corrective treatment for red right knee, swollen right knee/ swelling over the lateral supra patella pouch of the right knee and very painful right knee/right knee pain/knee tenderness were added and outcome was updated from unknown to recovered.Events red right knee, swollen right knee/ swelling over the lateral supra patella pouch of the right knee and very painful right knee/right knee pain/knee tenderness were updated to serious.Action taken was updated from unknown to not applicable.Clinical course was updated and text was amended accordingly.Follow-up information received on 29-may-2018.No new information received.Additional information was received on 08-jun-2018.Ptc results were updated.
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