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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 11/01/2015 |
Event Type
Injury
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Event Description
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It was reported that, on literature review ""comparison of clinical outcomes with three different intramedullary nailing devices in the treatment of unstable trochanteric fractures"", four (4) patients who underwent primary implantation with an intertan nail to treat an unstable trochanteric fracture experienced a postoperative hematoma.An unspecified amount of these patients required a further surgical drainage to resolve this complication.No further information is available.
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Manufacturer Narrative
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Internal complaint reference:(b)(4).Zehir, s., sahin, e., & zehir, r.(2015).Comparison of clinical outcomes with three different intramedullary nailing devices in the treatment of unstable trochanteric fractures.Doi: 10.5505/tjtes.2015.28227.
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Manufacturer Narrative
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Section h10: 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 images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes that could contribute to the reported event have been identified as post-operative healing issue 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.Internal complaint reference number: (b)(4).
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Search Alerts/Recalls
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