An event regarding dislocation involving an metal head was reported.The event was confirmed.Method & results: device evaluation and results: material analysis was performed that concludes "burnishing, scratches and third-body indentation were observed on the insert, which are common damage modes on uhmwpe.Debris was observed on the taper of the head.Eds showed the debris was consistent with a corrosion product and material transfer from the hip stem.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: 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: as per material analysis it is concluded that "burnishing, scratches and third-body indentation were observed on the insert, which are common damage modes on uhmwpe.Debris were observed on the taper of the head.No material or manufacturing defects were observed on the surfaces examined." if the additional information will be received, this investigation will be reopened and re-evaluated.
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