Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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: desai kb, karumuri k, mondkar sa, thayi c, vecham r, annapareddy a, reddy avg.Influence of vitamin d levels on outcomes and nosocomial covid-19 infection in patients undergoing total knee arthroplasty- a cohort study.J orthop.2022 nov-dec;34:8-13.Doi: 10.1016/j.Jor.2022.07.022.Epub 2022 aug 2.Pmid: 35935447; pmcid: pmc9344734.Objective and methods: this study aimed to audit the effects of vitamin d3 on the early functional outcomes, the incidence of nosocomial covid-19 infection and complications in patients undergoing elective total knee arthroplasty (tka).235 patients were divided into 2 cohorts matched by age, gender and asa grades.74 patients belonged to the d3 deficient group and 161 belonged to the d3 sufficient group.The mean preoperative scores in the sufficient group were higher than the deficient group.Similarly, the one-year postoperative scores in the sufficient group were significantly higher.A linear correlation was present between preoperative score & post-operative scores with serum vitamin d3 levels.Vitamin d3 deficient individuals had higher nosocomial covid-19 infection rate.The incidence of complications like dvt, embolism, stroke, infection and fracture were not statistically different in the two groups.All patients received cemented pfc sigma posterior stabilized implant.Results: vitamin d positively influences the outcomes of tka and protects against nosocomial covid-19 infection in patients undergoing elective tka.It offered no statistical significance with respect to other complications though.The two cohorts experienced the following complications: vitamin d3 deficient cohort covid 19 nosocomial infection: 8.30-day re-admissions covid 19: 3.30-day re-admissions hyponatremia: 1.Perioperative fracture: 1.Deep infection: 1.Pte: 1.Stroke: 1.Uti: 1.Vitamin d3 sufficient cohort covid 19 nosocomial infection: 8.30-day re-admissions acute diarrhea: 1.30-day re-admissions hyponatremia: 1.Perioperative fracture: 1.Deep infection: 1.Uti: 2.
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