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 Problems
Impaired Healing (2378); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4)."clinical effect of pfna and intertan internal fixation in the treatment of elderly intertrochanteric fracture." doi: 1673-7210 (2020)10(c)-0099-04.
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Event Description
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It was reported that on literature review "clinical effect of pfna and intertan internal fixation in the treatment of elderly intertrochanteric fracture", 1 patient suffered from delayed healing fracture.It is unknown how the event was treated.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, per complaint details, the article noted one patient suffered from delayed healing fracture.Patient specific clinically relevant documentation has not been provided as of the date of this medical investigation and it was communicated that there was ¿no more information¿.The current patient health status remains unknown.The clinical root cause of the reported delayed healing/union could not be further assessed.The patient outcomes beyond that which was documented in the article could not be determined.No further medical assessment is warranted at this time.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 patient condition and/or post-operative healing issue.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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