SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71421377 |
Device Problem
Break (1069)
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Patient Problem
Injury (2348)
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Event Date 05/07/2019 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed on the patient due to set screw backed out of the poly.There was a significant defect on medial aspect of femur so the decision was made to change the femur.No procedure details reported.
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Manufacturer Narrative
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The associated complaint devices were not returned.The clinical/medical team concluded, without the requested supporting clinical documents, a thorough medical investigation cannot be rendered.Should any clinical information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
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Search Alerts/Recalls
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