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Model Number 164-02-14 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 06/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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As reported, approximately 16 months postop this (b)(6) y/o female¿s initial right tha, the hip became infected and revised.All total hip devices were removed and insertion of antibiotic spacer.Patient was last known to be in stable condition following the event.Devices were disposed by hospital.
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Manufacturer Narrative
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Section h10: (h3) the evaluation noted that bassed upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to the patient¿s infection.
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Search Alerts/Recalls
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