The literature article entitled ¿management of extensive talar osteolysis with agility total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation¿, by thomas s.Roukis, dpm, phd, facfs, et al, published in the journal of foot and ankle surgery, 53 (2014), 108-113; was reviewed.The purpose of the article was to describe a technique for the management of massive cystic changes and bone loss secondary to aseptic osteolysis and subsidence of the talar component of failed agility total ankle replacement systems.The article describes this as an management of extensive talar osteolysis associated with failed agility total ankle replacement systems, they used geometric metal-reinforced polymethylmethacrylate cement augmentation.This technique preserves the subtalar joint and provides immediate component stability and restoration of component alignment and height.It is also a cost-effective alternative to the other available options and still allows for additional revision should late failure occur.The options for revision of the talar component depend on whether the failed system was an agility or agility lp tars.The revisions included a talar component and an insert; sizes were determined based upon which implant was being revised.The authors also report that this technique has not been thoroughly studied to date for revision total ankle replacement.Although, it has worked well in the three patients they have treated, additional study is warranted before widespread use can be advocated.
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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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