It was reported by an attorney that the patient underwent a knee replacement on (b)(6) 2022 and an unknown suture was used.It was reported that the suture broke and the wound was re-closed with staples on (b)(6) 2022.It was reported that the patient was admitted to the hospital for five days on (b)(6) 2022.It was reported that the patient experienced an infection and was treated with three different medications.Medications that were possibly given at home were eparinflush 5ml, sodchloride 10ml, dancomycin 750ml.Last in-home visit from the nurse was (b)(6) 2022.Patient is currently doing ok, and the infection has finally been eradicated.No additional information is provided.
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Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare® active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.Additional information: d1, d2, g4, h6.Additional information received: it was reported that the patient underwent a right computer assisted total knee arthroplasty on (b)(6) 2022, utilizing the #1 stratafix, the arthrotomy was closed, subcutaneous closed 2-0 vicryl and skin with 3-0 monocryl.It was reported that the patient underwent right total knee revision on (b)(6) 2022 noting a dehiscence of the quadriceps tendon, the medial retinaculum and most of the patellar tendon repair.It was reported that the patient underwent suture removal on (b)(6) 2022 with knee pain and increased swelling it was reported that the patient was admitted from (b)(6) 2022 - (b)(6) 2022 for concern of infected hardware.Positive for sepsis arthritis.The patient underwent right revision total knee arthroplasty w/ irrigation and debridement on (b)(6) 2022.The patient was discharged with an iv.
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