The literature article entitled, "feasibility and safety of 2-day discharge after fast-track total hip arthroplasty: a chinese experience" written by guojing yang, md, wanchen chen, md, wenliang chen, md, xiaojun tang, md, yijiang huang, md, and lei zhang, md published by the journal of arthroplasty 31 (2016) 1686e1692 http://dx.Doi.Org/10.1016/j.Arth.2016.02.011 on 17 february 2016 was reviewed for mdr reportability.The purpose: "the primary purpose of this prospective randomized study was to investigate the feasibility and safety of early discharge after fast-track tha in a chinese population." data was compiled from 126 patients in the fast track (ft) group and 132 patients in the standard program (st) group receiving tha between november 2013 and april 2014 with a follow up of 3 months.Complications at 30 month are included in adverse events as well.Patients received depuy pinnacle cups and either corail or summit stems.Bearing surfaces are not specified but it is reasonable to conclude the femoral head and liner were depuy products.The article does not provide adequate information to determine exact quantities of products as patients may experience more than one adverse events.The article does not provide information regarding interventions for adverse events.Adverse events: stroke, cardiac infarction, dvt, pulmonary embolism, infection, fracture (unspecified), death (1 accounted for in the st group), nausea, vomiting, dizziness, cognitive dysfunction, stroke, dislocation.
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Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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.Additional narrative: product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot null.Device history batch null.Device history review null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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