SMITH & NEPHEW, INC. TRAUMA IMPLANT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Device Problem
Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Event Description
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In a scientific publication, mekhail et al., "bone transport in the management of posttraumatic bone defects in the lower extremity" it was reported that following an ilizarov external fixation procedure to treat a lower extremity injury, the patient presented forefoot gangrene and an angiogram demonstrated peripheral vascular disease.The patient underwent femoropopliteal bypass and tarsometatarsal amputation.Later, there was a deep infection and persisting pain, so a transtibial amputation was performed.
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Manufacturer Narrative
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It was reported from a literature review from the paper: 'bone transport in the management of posttraumatic bone defects in the lower extremity" by mekhail et al., that the patient presented forefoot gangrene and an angiogram demonstrated peripheral vascular disease.The patient underwent femoropopliteal bypass and tarsometatarsal amputation.Later, there was a deep infection and persisting pain, so a transtibial amputation was performed.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The paper was published in 2004.The cause of the reported event was stated as deep infection.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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