SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
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Catalog Number 71291302 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/21/2018 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed due to a emperion stem fracture.Intraoperatively it was found that the patient was infected, all the implants were removed and replaced with competitor devices.
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Manufacturer Narrative
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Reviewing the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that this even was already reported on the report 1020279-2019-03999, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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