The literature article entitled, "durability of second-generation extensively porous-coated stems in patients aged 50 and younger" written by jennifer a.Moyer bs, catherine m.Metz md, john j.Callaghan md, david w.Hennessy bs, and steve s.Liu md published by clinical orthopedic related research published online 1 september 2009 was reviewed.The article's purpose was to report on whether second-generation extensively porous-coated cementless femoral stem in patients younger than 50 years of age would (1) be durable in terms of revisions; (2) provide high functional scores and reduce thigh pain; and (3) show radiographic durability of fixation and reduction in stress shielding.Data was compiled from 90 patients (89 hips) age 50 and younger from june 1994 to december 1999.The article reports that the prodigy femoral stem was mated with either non-depuy acetabular or depuy duraloc acetabular components.The article does not specify which acetabular components can be associated with the specific adverse events, and the article does not provide adequate information to determine accurate quantities.Article states no infections or loose components.Depuy products utilized: prodigy stem, duraloc cup (screws were used in all cases) and poly liner, metal head.Adverse events: mild thigh pain (no interventions, associated with femoral stem), dislocation (treated by revision and head and liner exchange), periprosthetic femoral fracture (treated by stem revision), liner wear (treated by revision with head and liner exchange), liner disassociation (treated by revision of head, liner, and cup exchange), osteolysis (radiographic findings, no interventions, commonly associated with liner wear), femoral stress shielding (radiographic findings, no interventions), acetabular radiolucency's (radiographic findings, no loosening's, no interventions).
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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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