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A cast stainless steel femoral head replacement prosthesis fractured midway down the stem within 13 months of implantation. Visual examination showed severe “orange peel” around the fracture on the concave side. This effect was not observed on the convex side, which suggested fatigue fracture. Metallographic examination of samples revealed an extremely large grain size and corroborated fatigue fracture. Chemical analysis indicated that the material conformed to the requirements for type 316L stainless steel. Substandard-size tensile bars machined from another prosthesis from the same manufacturer showing identical grain sizes were used for mechanical testing. Tensile tests indicated that the material did not meet the manufacturer's stated strength criteria in the portion of the stem that fractured. The failure was attributed to low strength, which resulted in fatigue. The extremely coarse grain size was considered a major factor in strength reduction.

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