Reported event: an event regarding wear/trunnionosis, corrosion, and altr involving a accolade stem was reported.The wear/trunnionosis and corrosion events were confirmed via evaluation of the returned device.Altr was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: material analysis: a material analysis was performed and concluded the following: "review of size 4 accolade ii 127 deg, catalogue # 6721-0435, lot code 55927503, v40 cocr lfit head 36mm/+5, catalogue # 6260-9-236, lot code 7w60ya and liner was completed for evidence of wear of the femoral head-neck interface.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper of the lfit head.Energy dispersive spectroscopy confirmed oxidation of the accolade ii stem and lfit head in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." -clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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: it was reported that the patient was revised due to pseudotumor and trunnionosis.Visual inspection of the returned device was performed as part of the material analysis: the material analysis concluded the following: "review of size 4 accolade ii 127 deg, catalogue # 6721-0435, lot code 55927503, v40 cocr lfit head 36mm/+5, catalogue # 6260-9-236, lot code 7w60ya and liner was completed for evidence of wear of the femoral head-neck interface.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper of the lfit head.Energy dispersive spectroscopy confirmed oxidation of the accolade ii stem and lfit head in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." additional information such as medical records is required to confirm pseudotumor/altr in the patient.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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