SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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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, author: zhang junhui et all., "analysis on the short-term and medium-term efficacy of aseptic prosthesis loosening and revision after application of extensive porous coating stem in the primary hip joint replacement" it was reported that four patients had difficulty in removing the prosthesis, this was fixed with distal femoral windows.The patients were implanted with an echelon stem and it is unknown which other devices the patients had implanted.
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Manufacturer Narrative
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It was reported from a literature review from the paper: 'analysis on the short-term and medium-term efficacy of aseptic prosthesis loosening and revision after application of extensive porous coating stem in the primary hip joint replacement' by zhang junhui, et al that the patient had difficulty removing the prosthesis.This was treated with a wire cable.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.There is not enough information to make a cross-check between the patient and the device involved, therefore no potential causes of the reported event could be determined.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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