"the literature article entitled, ""cementless tha for the treatment of osteonecrosis at 10-year follow-up: have we improved compared to cemented tha?"" written by nicholas a.Bedard bs, john j.Callaghan md, steve s.Liu md, justin j.Greiner bs, alison l.Klaassen ma, and richard c.Johnston md published by the journal of arthroplasty 28 (2013) 1192¿1199 accepted by publisher 9 september 2012 was reviewed.The article's purpose was to report on results of 66 cases of cementless thas implanted between november 15, 1993 and december 8, 2000.It is noted that all femoral components were depuy products.Acetabular components were mixed between depuy and non depuy.All bearing surfaces were mop.Article reports in narrative description that only 10 revision surgeries were performed and provides the patient identifiers along with the noted adverse events in table 3 page 1195.Each patient is captured individually in linked complaints.Depuy products utilized: aml stems, prodigy stems, duraloc cups, pinnacle cups, metal heads, poly liners." this complaint captures case 10 a (b)(6) year old male with 12.9 years time to revision from original implantation for femoral component loosening.Procedure: duraloc marathon liner exchange and femoral stem revision with head exchange from 26 to 32 mm.
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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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