The literature article entitled, "subtrochanteric shortening and derotational osteotomy in primary total hip arthroplasty for patients with severe hip dysplasia" written by john l.Masonis, md, jig v.Patel, frcs(orth), andrew miu, frcs, robert b.Bourne, md, richard mccalden, md, steven j.Macdonald, md, and cecil h.Rorabeck, md published by the journal of arthroplasty vol.18 no.3 suppl.1 2003 was reviewed.The article's purpose is report on the authors' experience with 21 tha combined with a transverse subtrochanteric shortening and derotational osteotomy with an average of 5 years of follow-up (minimum, 2 years).It is noted that depuy srom stem, solution stem and non depuy stems were in conjunction with non depuy products.The adverse events associated with cemented group were non depuy.Only one depuy stem was associated with uncemented adverse event which was a solution stem that was radiographically determined as loose at 84 months post implantation and has been scheduled for revision.Depuy products utilized: srom stem, solution stem.Adverse events: radiographic diagnoses as loose (scheduled revision not yet performed).
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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 associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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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