Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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"this complaint is from a literature source.The following literature cite has been reviewed: riemer k, lange j.Early periprosthetic hip joint infection managed by cementless one-stage revision - a case series.J bone jt infect.2022 feb 25;7(1):43-50.Doi: 10.5194/jbji-7-43-2022.Pmid: 35251904; pmcid: pmc8892566.Objective and methods: the purpose of this study is to evaluate the effectiveness of cementless one-stage revision for early periprosthetic joint infection (pji) in elective primary total hip arthroplasty (tha) regarding risk of re-operation with exchange of implants in 18 patients between january 2012 and march 2018.Early pji is defined as confirmed infection within 6 weeks of primary tha with clinical signs of fever, erythema, wound drainage, and pain, lab results of elevated crp, leukocytosis, and positive cultures, and direct fistulation (deep infection) to the joint.All stage 1 revisions followed the coriha protocol requiring extensive biofilm debridement during revision, drape and instrumentation changes, patient re-sterilization between removal and implantation, and no use of drains or pain catheters.All patients retained their revision devices by end of follow-up.Patient 14: 76 yo female, bmi 27.7.Primary implants: pinnacle gription cup/unknown liner paired with competitor stem/head.Intraoperative culture: s.Aureus, gas.Iv/oral antibiotics: yes.Revised with: depuy pinnacle cup/unknown liner and competitor stem/head.
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