An event regarding disassociation and loosening involving a mrh femoral component was reported.The disassociation between the femoral component and the stem was confirmed by medical review but the event of loosening of the femoral component was not confirmed.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 21-may-2019.The returned device were examined with the aid of a stereomicroscope at magnifications up to 50x.This inspection indicated that the femoral component were returned in the assembled condition.Bone cement was observed on the proximal surface of the femoral component.Scratching was observed on the articulating surface of the femoral component.The threaded portion of the femoral component was inspected and noticed that debris on the internal thread; this debris was collected on an sem stub for further analysis.Energy dispersive spectroscopy (eds) analysis was performed on the femoral component and debris from femoral component.Eds showed that the femoral component is consistent with its respective drawing.The elemental constitute of the debris from femoral component is ca-p-s which is consistent with biological material.Dimensional and inspection were not performed as the product was returned damaged.Damage consistent with scratching was observed on the articulating surface of the femoral component.Damage present on the articulating surface is consistent with burnishing, scratching, and third body indentations.Eds showed that each component is consistent with its respective drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.Clinician review: a review of the provided medical record was deemed insufficient by a clinical consultant indicated: provided x-rays confirm disassociation.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the mar report indicates that damage consistent with scratching was observed on the articulating surface of the femoral component.Damage present on the articulating surface is consistent with burnishing, scratching, and third body indentations.Eds showed that each component is consistent with its respective drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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