Model Number 1217-35-500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Infarction, Cerebral (1771); Hematoma (1884); Pain (1994); Tissue Damage (2104); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 07/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation is a non-healthcare professional.(b)(4).
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Event Description
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Litigation alleges stroke, heart attack, metal wear, metallosis, and elevated metal ions.Doi: (b)(6) 2010; dor: (b)(6) 2016; (left 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.E3 initial reporter occupation: lawyer.
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Search Alerts/Recalls
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