Ppf and sticker sheets received.Ppf alleges stroke, heart attack, fracture (component), dislocation (open & closed reduction), infection, loosening of stem and elevated metal ions.At this time it¿s unknown where the fracture occurred.If/when more information is received, the pc will be updated as needed.Doi: (b)(6) 2011 (liner & head); doi: (b)(6) 2010 (cup, screw, stem); dor: none reported; left hip.See (b)(4) right hip 1st revision; (b)(4) left hip 1st revision; (b)(4) right hip 2nd revision.
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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 will be filed as appropriate.
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