87 JDL DEPUY ORTHOPAEDICS, INC.

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION IN 1991. PRODUCT/LOT INFO WAS NOT PROVIDED FOR THE LINER ASSOCIATED WITH THIS REPORT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

PT REVISED FOR LOOSE ACETABULAR COMPONENT, OSTEOLYSIS AND POLYETHYLENE WEAR.