An event regarding corrosion & fracture of an lfit morse taper head was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis indicated: "corrosion was observed between the head taper and stem trunnion of the omnifit stem.The base alloy of the stem was consistent with an astm f75 alloy.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: review of medical records by a consulting clinician indicated: "other than the device corrosion and fatigue fracture the completed material analysis reviewed found no other material or manufacturing defects.Further documentation required to further complete this assessment would include: operative reports, surgical implant records from the surgeries, pre and post op xrays from the index and revision surgeries, outpatient office/clinic notes." device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: a material analysis concluded: "corrosion was observed between the head taper and stem trunnion of the omnifit stem.The base alloy of the stem was consistent with an astm f75 alloy.No material or manufacturing defects were observed on the surfaces examined." it was also noted that the "the origin of the fracture occurred in the region of corrosion and progressed through fatigue and final fracture." if additional information become available, this investigation will be reopened.
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