Wear debris. An environmental issue in total joint replacement.

There is a growing concern that osteolytic lesions, often adjacent to otherwise stable implants, are a recent phenomenon caused by some recent change in polyethylene, metal, or other aspect of the total hip construction. This study investigates the possibility that bearings and modular connections used in modern hip replacements are an unappreciated source of particulate debris. Measurements taken from contemporary femoral bearings show a significant mismatch in both surface finish and sphericity of mating metal and polyethylene components, with sphericity of inserts being much worse then sphericity of femoral heads. The tolerances for sphericity of polyethylene inserts were further changed by the placement of an insert into its metal shell. Hip simulator tests of assembled inserts and shells showed greater polyethylene weight loss for metal-backed shells than for inserts alone. Bending and torsional tests of metal/metal modular connections showed that dynamic loads can release large numbers of debris particles from taper junctions. Because osteolytic lesions clearly are associated with overload of tissue by debris particles, the design, manufacture, and tolerances of modular connections in total hip replacement all seem to require reevaluation.