Reported event an event regarding loosening involving a omnifit stem was reported.The event was confirmed via medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: x-ray confirms loose stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: x-ray confirms loose stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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