SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PRSTHSS,HIP,SMICNSTRND,UNCMNTD,MTAL/POLYMER,PROS
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Catalog Number 71330001 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/24/2017 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed to remove all the parts due to infection.
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Manufacturer Narrative
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The associated complaint device was not returned.The clinical/medical team concluded, this is a complaint from (b)(6) reporting a revision of a reflection hip secondary to an infection was performed on (b)(6) 2017.All the components were removed.It was communicated that no further information would be forthcoming.No date for the primary surgery was provided.No clinical/medical documents, x-rays nor, operative reports were provided.Based on the lack of information, an investigation cannot be completed and the root cause of the infection cannot be concluded.No patient information has been presented at this time.Should any relevant information become available this complaint can be re-assessed.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved and/or device information our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
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