The literature article entitled, "the effect of size for a hydroxyapatite-coated cementless implant on component revision in total hip arthroplasty: an analysis of 41,265 stems" written by wayne t.Hoskins, phd, roger j.Bingham, fracs, michelle lorimer, and richard n.De steiger, phd, fracs (orth) published by the journal of arthroplasty accepted by publisher 30 october 2019 was reviewed.The article's purpose was to investigate whether there was a difference in revision rate for smaller stems with focus on depuy corail stems.Data was compiled from 41,265 primary thas from the australian orthopaedic association national joint replacement registry.The article notes that the smaller corail stems have 4 times the rate of revision compared with the larger femoral sizes.It is assumed that the corail stems were utilized with depuy femoral heads, cups and liners.Depuy products identified: corail stem adverse events: revisions for loosening, dislocation, infection, femur fracture and malposition.No further information provided regarding reasons for revision.
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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.H10 additional narrative: corrected: h6.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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