SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SHORT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKN02100105 |
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 06/01/2021 |
Event Type
Injury
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Event Description
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It was reported that, on literature review "clinical study of standard intertan intramedullary nail and extended intertan intramedullary nail in the treatment of intertrochanteric fracture of senile femur", 4 patients who initially underwent primary implantation of a short trigen intertan nail to treat elderly femoral intertrochanteric fractures experienced delirium postoperatively.No specific details were provided 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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Internal complaint reference: (b)(4)."clinical study of standard intertan intramedullary nail and extended intertan intramedullary nail in the treatment of intertrochanteric fracture of senile femur".Doi: 10.3969/j.Issn.1009-5519.2021.12.030.
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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 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 product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to post-operative complication and/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 product 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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