DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Catalog Number 523418 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Infarction, Cerebral (1771)
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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.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.
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Event Description
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Ppf, sticker sheets, implant records received.Ppf alleges stroke and heart attack.Doi: (b)(6) 2013 - dor: none reported (right hip).Doi: (b)(6) 2005 (stem, sleeve, and apex hole eliminator).This pc is for the allegations after first revision of the right hip.See pc-(b)(4) for the first revision.
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Search Alerts/Recalls
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