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Septic knee joint in the left knee [arthritis bacterial] product lot issue [product quality issue] will have to have their defibrillator removed [implantable defibrillator removal] (b)(4) is a serious, complaint, spontaneous case received from a pharmacist in united states.This report concerns a (b)(6) who experienced septic knee joint in the left knee and a product lot issue during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 2 ml, dose unknown, weekly, for osteoarthritis from (b)(6) 2018.It was reported that the patient completed a series of three weekly euflexxa injections on (b)(6) 2018 on both knees.The patient was reported to be hospitalized on (b)(6) 2018 with septic knee joint in the left knee.It was reported that because of the septic knee joint, the patient will have to have their defibrillator removed.The lot number of the associated euflexxa was n10839c with an expiration date of 04-nov-2018.The facility has quarantined the remaining lots of euflexxa because of having two patients who received this lot and experienced the same ae.The facility would like the lots of euflexxa to be tested.The facility has discontinued use until further notice was provided.The patient was hospitalized on (b)(6) 2018 due to septic knee joint in the left knee.The septic knee joint in the left knee was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of the events was not recovered.The patient`s medical history was significant for defibrillator (from unknown start date to unknown stop date).Concomitant medication use was not reported.The event of septic knee joint in the left knee was serious.The event of product lot issue was non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: link: same reporter = (b)(4).An initial investigation of the concerned was performed.No potential cause for the ae was discovered.It was concluded that the lot is safe to use.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 manufacturer.No corrective action was done by the manufacturer or requested by regulators.
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Septic knee joint in the left knee [arthritis bacterial].Bacterial species present in culture was mssa [staphylococcal infection].Sepsis [sepsis].Had to have to have their defibrillator removed as a result of the infection [implantable defibrillator removal].Product lot issue [product quality issues].Case (b)(4) is a serious complaint, spontaneous case received from a physician in united states.Follow up was received from the patient's physician and from a regulatory authority.This report concerns a 70-year-old who developed septic knee joint in the left knee which tested positive for bacterial species methicillin-sensitive staphylococcus aureus (mssa), sepsis, had to have his implantable cardioverter defibrillator (icd) removed as result, and experienced product lot issue during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, unknown dose, weekly, for osteoarthritis from (b)(6) 2018.It was reported that the patient completed a series of three weekly euflexxa injections on (b)(6) 2018 on both knees.The patient was reported to be hospitalized on (b)(6) 2018 with septic knee joint in the left knee.Upon physical examination of the knee it was noted that the left knee was hot, red, painful and swollen.A bilateral x-ray was performed on (b)(6) 2018 which showed marked to moderate medial and lateral joint space narrowing with subchondral sclerosis and marginal osteophyte formation supportive of bilateral osteoarthritis.He was diagnosed with sepsis that was thought to develop from the knee joint as the source of infection.On (b)(6) 2018 the patient was admitted and underwent knee arthroscopy and had an incision and drainage performed on the left knee, picc line placement, and iv antibiotics in the operating room.The patient also had to have their icd removed because of the infection.The patient was treated with intravenous cefazolin.The physician reported that they were not aware of any other possible explanations for the events and reported the causality of the events in relation to euflexxa as possible.The lot number of the associated euflexxa was n10839c with an expiration date of 04-nov-2018.The facility has quarantined the remaining lots of euflexxa because of having two patients who received this lot and experienced the same ae.The facility would like the lots of euflexxa to be tested.The facility has discontinued use until further notice was provided.The patient was hospitalized on (b)(6) 2018 due to septic knee joint in the left knee and sepsis.The septic knee joint in the left knee and positive culture for mssa was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of septic knee joint in the left knee and sepsis was recovering/resolving, the outcome of bacterial species present in culture was mssa was recovering/resolving, the outcome of product lot issue was recovering/resolving, the outcome had to have their defibrillator removed was recovering/resolving.The patient`s medical history was significant for non-smoker, defibrillator, and abstains from alcohol.The patient`s procedures included physical examination (from unknown start date to unknown stop date) and bilateral x-rays of the knees (from (b)(6) 2018).The physician provided that the patient did not have any history of known drug allergies, chronic pain, obesity, physical therapy, or rheumatoid arthritis.The patient participated in physical activity (walking).The following concomitant medications were reported: coreg, lasix, losartan, and trazodone.Relevant laboratory values included: culture: see note, ni (positive), (b)(6) 2018- mssa.The events septic knee joint in the left knee, bacterial species mssa present in culture, and sepsis were reported as serious.The events of product lot issue and had to have to have their defibrillator removed were reported as non-serious.At the time of reporting the case outcome was recovering/resolving.Additional information was received by the patient's physician on 16-mar-2018 and from a regulatory authority on 20-mar-2018; follow up 1: additional reporter added.Patient medical history, procedure, and lab data added.Concomitant medications added.Additional event of mssa and sepsis added.Narrative updated.Conclusion from the company final complaint management report: the investigation detailed above did not identify any quality issue in euflexxa lot n10839c.Sterility test of this batch passed successfully.No clear relation was found to previous complaints.Hence, no capa will be implemented at this point.Troutine trend analysis are performed of all complaint types.If an adverse trend is established, the need for capa will be reevaluated.The root cause for the patient knee infection is unknown; the investigation did not find any relevant potential root cause in the manufacturing process.However, an infection can be caused during the injection procedure even if the product fulfill all specifications.Contaminant identification from the infected area is highly important to be taken into consideration while facing similar safety issues.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: link: same reporter = (b)(4).Case number, others = (b)(4).Case number, complaint = (b)(4).Case number, complaint = (b)(4).E2b company number = (b)(4).Mw 3500a mfr.Rpt.# = initial report.Case number, others = mw(b)(4).An initial investigation of the concerned was performed.No potential cause for the ae was discovered.It was concluded that the lot is safe to use.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 manufacturer.No corrective action was done by the manufacturer or requested by regulators.
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