DEPUY ORTHOPAEDICS, INC. 1818910 PINN MULTIHOLE W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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Catalog Number 121730052 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930)
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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: attorney.
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Event Description
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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.
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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.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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Search Alerts/Recalls
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