The literature article entitled, "highly variable femoral morphology in osteoarthritic chinese: are prostheses today sufficiently suitable?" written by yunjie zhang, md, xiaofeng wang, md, phd, zongming wu, md, qing xia, md and yunchao shao, md, phd published by the journey of knee surgery made available online 14 mar 2017 was reviewed.The article's purpose to provide anthropometric data for domestic prosthetic design by measuring the parameters of virtually resected distal femurs in chinese patients undergoing tka using a 3d reconstruction process, and to investigate how well the multiple femur prostheses accommodate the femur of chinese patients.Data was compiled from 142 knees (35 male and 107 females) in age ranges of 54-85 years old.Implants utilized were depuy and non depuy.Patella resurfacing was not mentioned and cement manufacturer was not identified.The article focused on the femoral component fit upon the distal femur.The article does not provide adequate information to determine accurate quantities.Depuy products utilized: sigma pfc and attune.Adverse events: underhang and overhang of femoral component (treatment not specified).
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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.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.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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