Catalog Number 121740500 |
Device Problem
Fracture (1260)
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Patient Problems
Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation: reporter is a non-healthcare professional.(b)(4).
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Event Description
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Litigation alleges stroke, heart attack, component fracture, dislocation, infection, loosening of stem and elevated metal ions.Doi: (b)(6) 2011 (head, liner & stem); doi: (b)(6) 2009 (cup, screw); dor: (b)(6) 2012 (right hip).
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Manufacturer Narrative
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Product complaint # (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.Device history lot = > dw1b64000.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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Search Alerts/Recalls
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