Additional narrative: examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product/lot code combinations since their release to distribution.Additional event information and investigational inputs were requested but not provided.The initial reporting stated the patient was revised to address malpositioning of the acetabular component.Because no patient x-rays have been provided, no comment on positioning can be made.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
|