Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Unintended Movement (3026); Migration (4003)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/11/2011 |
Event Type
malfunction
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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 lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.(b)(4).
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Event Description
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"literature article entitled, ¿subsidence of the corail femoral component in the elderly.A retrospective radiological review¿ by mohammad faisal, et al, published by hip international (2011), vol.21, no.3, pp.325-329, was reviewed.The aim of our study was to look at the radiological results of uncemented tha in the elderly, to identify the number of patients who developed subsidence within the first year after surgery, whether this was progressive, whether it was related to bone quality, and whether the stems ultimately became stable.All patients were implanted with corail femoral stems.This complaint captures the 13 patients with identified stem migration.Case 1 is captured in (b)(4).Case 2 through case 13 are captured in the guidance document and are linked to (b)(4)." (b)(6) female patient showed signs of radiologically identified corail stem migration of 4.28-mm.Stem was stable with bony ingrowth at final follow-up.No intervention required and no patient consequences.
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Search Alerts/Recalls
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