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Fevers [pyrexia], pain in right knee [arthralgia], right knee swelling [joint swelling], right knee redness [erythema], requesting surveillance of euflexxa injections used [device quality issue] [device issue].Case description: (b)(4) is a serious complaint, spontaneous case received from a physician in united states.This report concerns a (b)(6) male who experienced fevers, pain in right knee, right knee swelling and redness, and device issue during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 2 ml, 2 ml, weekly, for osteoarthritis from (b)(6) 2018 to (b)(6) 2018.It was reported that the patient received his three injections of euflexxa on (b)(6) 2018, and (b)(6)2018 to the right knee.Immediately after receiving the third injection on (b)(6) 2018, he experienced pain in the right knee, swelling, redness and fevers.The physician reported that the right knee was aspirated and purulent drainage was obtained.Cultures were sent and the results were pending.The patient was then taken to the operating room for an arthroscopy and debridement of right knee.It was reported that the patient was receiving unspecified intravenous antibiotics.Lot number was reported as n14370a with an expiration date of 14-apr-2019.The events of fevers, pain in right knee, right knee swelling and redness were medically significant due to hospitalization for treatment.Action taken with euflexxa was not applicable.At the time of this report, the outcome of fevers was not recovered, the outcome of pain in right knee was not recovered, the outcome of right knee swelling was not recovered, the outcome of right knee redness was not recovered, the outcome of device issue was not recovered.The patient`s procedures included right knee aspiration (from (b)(6) 2018).The following concomitant medication was reported: fluoxetine (from an unknown start date to an unknown stop date).Relevant laboratory values included: culture: unknown results, ni (unknown), (b)(6) 2018.The events fevers, pain in right knee, right knee swelling, right knee redness were reported as serious.The event of device issue was reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).This ae occurred in the us and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because did not occur in a eu + efta country and did not result in a corrective action by the manufacture no corrective action was done by the manufacturer or requested by regulators.
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Reactive/allergic synovitis [fevers, knee pain, knee swelling, knee redness, effusion and limited range of motion] [synovitis].Requesting surveillance of euflexxa injections used [device quality issue] [device issue].Case description: case (b)(4) is a serious complaint, spontaneous case received from a physician in united states.This report concerns a 70-year-old male who experienced reactive/allergic synovitis [fevers, knee pain, knee swelling, knee redness, effusion and limited range of motion] and a device quality issue during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 2 ml, 2 ml, weekly, for osteoarthritis from (b)(6) 2018.It was reported that the patient received his three injections of euflexxa on (b)(6) 2018 to the right knee.Immediately after receiving the third injection on (b)(6) 2018, he experienced pain in the right knee, swelling, redness, a large effusion, fevers and limited range of motion.The patient was seen by their physician on (b)(6) 2018.The physician reported that the right knee was aspirated and purulent drainage was obtained.The patient was taken to the operating room for an arthroscopy and debridement of right knee.Cultures were sent prior to antibiotics, intra-operatively and post-operatively.Initially the patient was started on intravenous vancomycin and then was converted to rocephin for a presumed skin flora infection by an infectious disease specialist.After two weeks of antibiotics and prolonged negative cultures, the antibiotics were discontinued.The physician reported that the patient markedly improved after discontinuation of antibiotics and was started on unspecified oral steroid taper.At the patient's last visit with his physician, there was no effusion present and flexion was at 100 degrees.The physician reported the presumed diagnosis was reactive/allergic synovitis.Lot number was reported as n14370a with an expiration date of 14-apr-2019.The event of reactive/allergic synovitis [fevers, knee pain, knee swelling, knee redness, effusion and limited range of motion] was medically significant due to hospitalization.Action taken with euflexxa was not applicable.At the time of this report, the outcome of requesting surveillance of euflexxa injections used [device quality issue] was recovered.In 2018, the outcome of reactive/allergic synovitis [fevers, knee pain, knee swelling, knee redness, effusion and limited range of motion] was recovered.The patient`s medical history was significant for non-smoker, physical therapy, obesity, and chronic pain.The patient's physician denied a history of knee surgery, regular exercising, allergies, physical activity, rheumatoid arthritis and did not know if the patient had a history of alcohol use.The patient`s procedures included right knee aspiration (from (b)(6) 2018) and an x-ray of right knee (from unknown start date to unknown stop date).The following concomitant medication was reported: fluoxetine (from an unknown start date to an unknown stop date).Relevant laboratory values included: culture: negative, ni (negative), (b)(6) 2018.Culture: negative, ni (negative), date unknown.Culture: negative, ni (negative), date unknown.White blood cell count: 95% (unknown), date unknown.An initial unspecified cell count of 70,000, ni (unknown), date unknown.The event reactive/allergic synovitis [fevers, knee pain, knee swelling, knee redness, effusion and limited range of motion] was reported as serious.The event requesting surveillance of euflexxa injections used [device quality issue] was reported as non-serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Additional information was received on 28-jun-2018 from the patient's physician (initial reporter): follow up 01- event of synovitis added and previous reported events subsumed under diagnosis.Additional medical history and lab data added.Narrative updated.Other case numbers: case number, others = (b)(4).Case number, complaint = (b)(4).Case number, complaint = (b)(4).Mw 3500a mfr.Rpt.# = initial report.This ae occurred in the us and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it did not occur in a eu + efta country and did not result in a corrective action by the manufacture no corrective action was done by the manufacturer or requested by regulators.
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