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
Hip Fracture (2349)
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Event Date 09/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4)."comparison of the long-term efficacy of dhs, pfna and intertan internal fixation in senile unstable intertrochanteric femoral fracturer".
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Event Description
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It was reported that on literature review "comparison of the long-term efficacy of dhs, pfna and intertan internal fixation in senile unstable intertrochanteric femoral fracturer", 1 patient had a lateral femoral trochanter wall fracture.No further information is available.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the literature article was reviewed.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.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.The contribution of the device 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 device 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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Search Alerts/Recalls
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