SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKN02100103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Confusion/ Disorientation (2553)
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Event Date 02/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case(b)(4)."effect comparison of three kinds of internal fixation in the treatment of osteoporotic intertrochanteric fracture".(b)(4).
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Event Description
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It was reported that, on literature review "effect comparison of three kinds of internal fixation in the treatment of osteoporotic intertrochanteric fracture", 3 patients, who initially underwent internal trochanteric fixation with an intertan nail to treat an osteoporotic intertrochanteric fracture, experienced delirium.No specific details were reported in regards of how was this complication treated or resolved.The patients' outcome is unknown.No further information is available.
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Manufacturer Narrative
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H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.It is noted within the attachments that no further information is available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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