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The failure of a proximal humerus internal locking system (PHILOS) used in a pantalar arthrodesis was investigated in this paper. PHILOS constructs are hybrids using locking and non-locking screws. Both the plate and the screws used in the fusion were obtained for analysis. However, only the plate failure analysis is reported in this paper. The implant had failed in several pieces. Optical and scanning electron microscopic analyses were performed to characterize the failure mode(s) and fracture surface. The chemical composition and mechanical properties of the plate were determined and compared to controlling specifications to manufacture the devices. We found that equivalent tensile strength exceeded at the locations of high stress, axial, and angular displacement and matched the specification at the regions of lower stress/displacement. Such a region-wise change in mechanical properties with in vivo utilization has not been reported in the literature. Evidence of inclusions was qualitatively determined for the stainless steel 316L plate failing the specifications. Pitting corrosion, scratches, discoloration and debris were present on the plate. Fracture surface showed (1) multi-site corrosion damage within the screw holes forming a 45° maximum shear force line for crack-linking, and (2) crack propagation perpendicular to the crack forming origin that may have formed due to the presence of inclusions. Fracture features such as beach marks and striations indicating that corrosion may have initiated the crack(s), which grew by fatigue over a period of time. In conclusion, the most likely mechanism of failure for the device was due to corrosion fatigue and lack of bony in-growth on the screws that may have caused loosening of the device causing deformity and pre-mature failure.

Failure Analysis of PHILOS Plate Construct Used for Pantalar Arthrodesis Paper I—Analysis of the Plate