The in vivo performance of 250 internal fixation devices: a follow-up study.

The in vivo performance of 250 retrieved internal fixation plates was evaluated. The corrosion characteristics and metallurgical properties of each implant were assessed and correlated with respective clinical performance. Screw-plate interface corrosion and screw surface corrosion were graded; Rockwell hardness, grain size, thin inclusion content, and heavy inclusion content measurements were made. The devices studied included 169 bone plates, 59 Richards type hip screw-plates and 22 Jewett type hip nail-plates. The devices remained in situ for an average of 26.3 months, with in situ periods ranging from 1 to 192 months. The majority of the plates (50.4%) were removed due to cause-related reasons, while the remaining devices (49.6%) were removed on a routine asymptomatic basis. The primary symptomatic removal reasons consisted of implant related pain, nonunion or malunion, infection, loosening and implant breakage. Upon stereomicroscopic examination, 89% of all plates exhibited some degree of interface crevice corrosion, and 88% of all screws exhibited some degree of surface corrosion. Statistical analysis of corrosion gradings and metallurgical data revealed significant correlations between the two. As was suggested in our previous study of a limited number of implants, this study demonstrates that stricter manufacturing standards for metallurgical properties would serve to enhance corrosion resistance and improve the in vivo performance of stainless steel internal fixation devices. It is also suggested that the routine removal of all internal fixation plates after fracture healing has been achieved would reduce the occurrence of symptomatic complications, such as implant breakage, implant loosening and implant related pain.