The associated devices were returned and evaluated.Visual inspection of the returned devices showed scratches on the stem likely sustained during removal of the device.Bone ongrowth was observed on the acetabular shell that appeared well adhered as it did not become dislodged with the application of manual force.Scratches inside the acetabular shell were observed.Deformation to the taper mouth of the femoral head were observed, which was also likely caused due to removal of the device.The polyethylene liner showed damage along the rim likely from removal, and showed it also showed discoloration likely due to lipid absorption.The polyethylene liner showed burnishing and signs of tunnel wear within the articulating region, which is consistent with the reported complaint of osteolysis.The screw showed deformation just below the head likely due to contact with the acetabular liner.No material or manufacturing deviations were observed during this investigation.No clinical supporting documentation has been provided with this case.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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