This complaint is from a literature source.The following literature article abstract has been reviewed: entitled: ¿influence of the concept of fast track surgery on the physiological and psychological rehabilitation of patients undergoing total knee arthroplasty ¿, by han guangtao and li haohuan, to be published with funding by national natural science foundation of china and natural science foundation of hubei province.Objective and methods: authors sought to understand the impact of fast track surgery on the physiological and psychological rehabilitation of patients having received total knee arthroplasties (tka).Sixty patients with arthritis undergoing total knee arthroplasty in the authors¿ hospital facility, from may 2017 to january 2019, were retrospectively analyzed.Patients who received fast track surgery (32 patients) according to the fast track ideas were involved in the fast track surgery group¿including preoperative education, intraoperative fluid management, and postoperative functional exercise.Patients with the same operation but conventional rehabilitation were divided into the conventional rehabilitation group.Hospitalization time, hospitalization cost, postoperative complication, nursing satisfaction during hospitalization, zung anxiety self-rating scale, zung depression and visual analogue score were compared between the two groups.Johnson & johnson attune total knee implants were used in all knees.Patellas were resurfaced.Cement manufacturers were not provided.Patient data was not provided by case number, or by age/gender demographics.Results: length of stay was 3 days less on average for the fast track group than for the conventional group (12.3 vs.15.8 days), and the time to first ambulation after surgery was on average 22 hours sooner (13.9 vs.35.2 hours), and hospital costs were almost half (82,012.50 vs.152,023 rmb).With regards to post-op complications in the 1st month, the fast track group experienced no dvts, no pes, no cardiovascular disorders, no utis, no periprosthetic infections, and no deaths.The conventional rehabilitation group on the other hand experienced 5 dvts, 2 cardiovascular disorders, and 7 utis (no specifics or treatment details were provided for any of these events).The fast track group reported, of the 32 patients, all average or better experiences, with the vast majority being satisfied or very satisfied; the conventional group of 28 was almost evenly distributed between dissatisfied/average, and satisfied, with only 3 very satisfied.Zung depressions scores followed a similar trend from pre-op condition to 3 days post-op, but the fast track group on average trended significantly better than conventional, markedly better in all indicators.
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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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