The literature article entitled, ""femoral stem fracture and in vivo corrosion of retrieved modular femoral hips"" written by j.Caitlin huot carlson, ms, douglas w.Van citters, phd, john h.Currier, ms, amber m.Bryant, be, michael b.Mayor, md, and john p.Collier, de published by the journal of arthroplasty vol.27 no.7 2012 accepted by publisher 21 november 2011 was reviewed.The article's purpose was to report on retrieved modular femoral stems and inspect for corrosion.All stems were srom stems.Article reports that femoral heads were ceramic or metal.Liners may have been metal, ceramic or poly and the cups are not identified but assumed to be depuy implants.Inspection revealed that most stems had some degree of 'fretting' or corrosion at modular junctions including stem and sleeve interface or (and) stem and head junction.However the article does not quantify the findings to modular junction locations in order to determine accurate quantities.Table 1 provided further detail of reasons stems were explanted.Each case is captured individually for reason of revision and any information provided in the table and article in linked complaints.This complaint captures case no 16 that received revision when the stem was explanted at 17.7 months post initial implant for reason of subsidence and loose stem.The patient¿s age was 56 and gender identity male.
|
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.
|