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Catalog Number UNKNOWN |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Discomfort (2330)
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Event Date 10/10/2008 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Webb, j.A., almaiyah, m., mcvie, j., & montgomery, r.J.(2008).Proximal femoral osteotomies in children using the richards hip screw: techniques, outcome and subsequent removal.Journal of children's orthopaedics, 2(6), 417-423.Doi: 10.1007/s11832-008-0127-8.
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Event Description
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It was reported that on literature review "proximal femoral osteotomies in children using the richards hip screw: techniques, outcome and subsequent removal", (1) patient was readmitted with increased discomfort; 2 weeks after derotation osteotomy, using a chs (compression hip screws) radiographs showed that the upper fragment had rotated around the screw and was loose.The osteotomy was repositioned and it was fixed with a standard ao tibial plate, contoured to fit the upper femur.The patient remained non-weight-bearing until bone union and had no further problems no further information is available.
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Manufacturer Narrative
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Given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, the literature article was reviewed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.However as of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided.Therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the limited information provided.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include, postoperative care, size selected or poor insertion 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 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.Internal complaint reference number: (b)(4).
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Search Alerts/Recalls
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