The patient was revised to address osteolysis around tibia and talar components.Original surgery was done around 10 years ago, no specific date given.The surgeon used bone graft and calcium phosphate to fill voids.Poly exchange.No surgical delay.Doi: (b)(6) 2010, dor: (b)(6) 2020, left ankle.
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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.
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