The literature article entitled, "early failure of primary total hip arthroplasty: is surgical approach a risk factor" written by marc r.Angerame, md, thomas k.Fehring, md, john l.Masonis, md, j.Bohannon mason, md, susan m.Odum, phd, and bryan d.Springer, md published by the journal of arthroplasty (2018) accepted by publisher 8 january 2018 was reviewed.The article's purpose is to evaluate the incidence of early failure of primary tha stratified by surgical approach.Data was compiled for 6,894 primary thas performed between 2007and 2014.Depuy products are identified in table 8 page 4 for failures due to femoral component loosening with srom listed amongst other non-depuy products.Narrative description provides information that femoral loosening failures were revised.No further information provided regarding products related to failures.Depuy products utilized: srom femoral stem.Adverse event: femoral loosening (treated with revision).
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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, a follow-up medwatch will be filed as appropriate.
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