It was reported that this surgery is this patient's second hip revision surgery in the past nine days due to infection.During her first revision surgery, performed on (b)(6), 2023, her primary femoral head and polyethylene liner were removed, and her hip was thoroughly irrigated and debrided.A replacement femoral head and a replacement polyethylene liner were then implanted.This most recent surgery was the first stage of a two-stage revision procedure due to the same infection.During this surgery, all of the patient's components were removed.Her hip was once again thoroughly irrigated and debrided.An antibiotic spacer construct, which included a prostalac cup, stem, and femoral head, was then implanted.There was no surgical delay.During the second stage of the two-stage procedure, which will occur once the patient is infection free, the antibiotic spacer will be removed and replaced by final hip revision components.Doi(for cup and stem): (b)(6), 2023, doi(for liner and head): (b)(6), 2023, dor: (b)(6), 2023, affected side: left hip.
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
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