Patient was revised to address poly wear and osteolysis.No device was returned to examine.Review of provided patient x-ray confirms the reported poly-wear.The femoral head is eccentrically loading the acetabular construct, indicating eccentric wear.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combination was not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine a root cause, the need for corrective action has not been identified.
|