06-sept-2019 literature article entitled: ¿does taper design affect taper fretting corrosion in ceramic-on-polyethylene total hip arthroplasty? a retrieval analysis¿ by matthew p.Siljander, md a, corinn k.Gehrke, ms, samantha d.Wheeler, bs, ali h.Sobh, md, drew d.Moore, md, michael a.Flierl, md, erin a.Baker, phd.Published in the journal of arthroplasty (2019) was reviewed for mdr reportability.The study¿s objective was to investigate the effect of taper design on taper corrosion and fretting in modular cop total hip arthroplasty systems.The models of prostheses used include biolox delta ceramic femoral heads of varying sizes and offsets, (3) corail femoral stems, (1) hps ii femoral stem, (18) s-rom femoral stem / sleeve, (11) summit stem.Acetabular cup and liner manufactures were not provided.The study identified the following to be adverse outcomes.It is not indicated what manufactured implants experienced what outcomes, therefore, all will be listed.1.) infection, 2.) periprosthetic fracture, 3.) aseptic loosening, 4.) pain, 5.) instability, 6.) leg length discrepancy, 7.) implant wear (femoral head: trunnion fretting, femoral stem: trunnion corrosion, femoral head: abrasion, burnishing, pitting, grooving/scratching, femoral stem: abrasion, burnishing, pitting, grooving/scratching, acetabular liner: abrasion, burnishing, pitting, grooving/ scratching, edge deformation.), 8.) revision surgery.
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 will be filed as appropriate.
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