Patient was revised to address pain and osteolysis from metal on metal product.Pseudotumor and necrotic bone was removed, the cup was retained and the patient was revised to a constrained liner.Recent blood ion levels were normal at.7 cobalt and.6 chromium.Doi: (b)(6) ,2006; dor: (b)(6) 2018; left hip.
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Product complaint # = > pc-(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, post market surveillance, 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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