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.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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The literature article entitled "revision techniques in total ankle arthroplasty utilizing a stemmed tibial arthroplasty system¿, written by james meeker, md, et al; published in techniques in foot & ankle surgery, volume 12, number 2, june 2013; was reviewed.The purpose of this article was to discuss revision ankle arthroplasty for failed implants.The article discusses indications for revisions, contraindications, surgical technique and outcomes.The article reports on revisions from an agility total ankle prosthesis to a non-depuy implant.There were 18 consecutive patients that were revised from agility tar to a non-depuy implant.That agility implant lasted a mean of 12.75 years (1.6 to 13.4 years) before revision.Indications for loosening were listed as mechanical loosening of the prosthesis (15), periprosthetic fracture (3), dislocated ankle prosthesis (1), and talar subsidence (1).All patients had symptoms of ankle joint pain upon clinical presentation.Adjunctive procedures during the revision were performed in 16/18 cases.Complications after the revision were related to non-depuy products.
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