Catalog Number PHA0-1254 |
Device Problems
Metal Shedding Debris (1804); Naturally Worn (2988)
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Patient Problems
Hematoma (1884); Necrosis (1971); Pain (1994); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Reaction (2414); Fibrosis (3167)
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Event Date 08/04/2014 |
Event Type
Injury
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Event Description
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Alleged patient revised due to mom complications: left sided hip pain, serum cobalt and chromium ion levels; elevated metal particle disease and a pseudotumor; brownish yellow fluid; black tissue; necrotic and fibrinous tissue; focal gaint cell reactions and wear debris; hematoma- left.
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Manufacturer Narrative
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This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01167, -01168, -01169.
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Manufacturer Narrative
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The complaint database was reviewed and analysis showed no trend for item/lot.
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Search Alerts/Recalls
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