Failures in stainless steel orthopaedic implant devices: A survey

Sivakumar, M.; Dhanadurai, K. Suresh Kumar; Rajeswari, S.; Thulasiraman, V.

doi:10.1007/bf00592147

Cited by 58 publications

(22 citation statements)

References 6 publications

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“…In those bone plates that failed by fracture, the occurrence of cracks at the screw hole adjacent to the loading roller is consistent with previous studies in which it was shown that plates are most susceptible to fracture at the level of the screw holes [3,11]. Manufacturing issues, including gross defects in the processing of the screw-hole and surface finishing, can influence implant fatigue life, and have been identified in bone plates [3].…”

Section: Discussionsupporting

confidence: 87%

“…To date, there has been little or no information about the mechanical performance of such implants nor about which factors, such as adherence to manufacturing quality standards, might affect such performance [6,8,[10][11][12][13]. This study shows that bone plates from selected implant manufacturers in the developed and developing worlds display significant differences in mechanical performance.…”

Section: Discussionmentioning

confidence: 80%

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Mechanical behaviour of low-cost dynamic compression plates correlates with manufacturing quality standards

Aluede

McDonald

Jergesen

et al. 2013

International Orthopaedics (SICOT)

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Purpose This study compares the mechanical properties of low-cost stainless steel dynamic compression plates (DCPs) from developing-world manufacturers, adhering to varying manufacturing quality standards, with those of high-cost DCPs manufactured for use in the developed world. Methods Standard-design ten-hole DCPs from six developing-world manufacturers and high-cost DCPs from two manufacturers in the developed world were studied. Nine plates from each manufacturer underwent mechanical testing: six in four-point monotonic bending to assess strength and stiffness and three in four-point bending fatigue. Statistical comparisons of the group means of monotonic bending test data were made, and a qualitative comparison was performed to assess failures in fatigue. Results Low-cost DCPs from manufacturers with at least one manufacturing quality standard had significantly higher bending strength and fewer failures in fatigue than did those from low-cost manufacturers with no recognised quality standards. High-cost DCPs demonstrated greater bending strength than did those in both low-cost groups. There were no differences in stiffness and fatigue failure between highcost DCPs and those low-cost DCPs with quality standards. However, high-cost DCPs were significantly less stiff and had fewer fatigue failures than low-cost DCPs manufactured without such standards. Conclusion Significant differences were found in the mechanical properties of ten-hole DCP plates from selected manufacturers in the developing and developed worlds. These differences correlated with reported quality certification in the manufacturing process. Mechanical analysis of low-cost implants may provide information useful in determining which manufacturers produce implants with the best potential for benefit relative to cost.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 80%

Mechanical behaviour of low-cost dynamic compression plates correlates with manufacturing quality standards

Aluede

McDonald

Jergesen

et al. 2013

International Orthopaedics (SICOT)

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“…These implants may fail following different fracture modes, simple or mixed, depending upon loading [2]. For the catastrophic failure of orthopaedic compression plates made out of AISI 316L stainless steel, several mechanisms have been reported in the literature, ranging from stress assisted corrosion, fretting and fatigue under low stresses and unidirectional bending, to ductile fracture assisted by nonmetallic inclusions [3][4][5]. A good post operative behaviour leads to complete cure for the patient, providing that the plate was properly fixed and an appropriate time period was given to allow the bone to heal.…”

Section: Introductionmentioning

confidence: 99%

Premature fracture of a stainless steel 316L orthopaedic plate implant by alternative episodes of fatigue and cleavage decoherence

Triantafyllidis

Kazantzis

Karageorgiou

2007

Engineering Failure Analysis

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“…Crevice corrosion sometimes occurs on stainless steel and titanium alloys between bone plate and screw, between bone cement and stem and so on. [10][11][12] However, crevice corrosion between material and tissue has not been reported. The prevention of mass diffusion by the cell layer may not be complete to cause typical crevice corrosion because cell membranes can transmit certain ions and molecules.…”

Section: Resultsmentioning

confidence: 99%

pH near Cells on Stainless Steel and Titanium

Hiromoto

Hanawa

2004

Electrochem. Solid-State Lett.

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Murine fibroblast L929 cells were cultured for 605 ks on 316L stainless steel and titanium specimens and a cell adhesive layer was formed. Tip of a tungsten microelectrode was placed at the intracell layer and a few millimeters above the cell layer, and pH values of the intra-and extracell layer were measured, respectively. The pH values of the intracell layer on metallic specimens were apparently lower than that of the extracell layer. Therefore, the pH on metallic materials decreases with cells, that is probably caused by corrosion reaction as well as chemicals generated by cells.When metallic biomaterials are implanted in the human body, tissues adhere to the surface of the materials. The tissues consist of cells that generate various biomolecules such as extracellular matrix and cell-adhesive proteins. 1 Then, when the cells adhere to the materials, the adsorption layer of biomolecules consisting of various kinds of amino acids, proteins, extracellular matrix, and cells is formed on the materials. Hence, the effects of living cells on the corrosion behavior and surface composition of the metallic biomaterials have been evaluated. 2-6 Dissolution of titanium is accelerated due to the hydrogen peroxide generated by macrophages. 2 With murine fibroblast L929 cells on a titanium specimen, cathodic reaction is retarded and diffusion resistance at the interface obtained by impedance measurement increases, indicating that diffusivity at the interface between titanium and cells decreases. 6 Precipitation of calcium and phosphate ions is prevented by culturing L929 cells on Co-Cr alloy, 316L stainless steel, and titanium specimens. 3-5 Furthermore, only when the L929 cells are cultured, sulfate ion in the cell culture medium is reduced and precipitates as sulfite or sulfide on 316L and titanium specimens. 3,5 This reaction is also observed on stainless steel and titanium alloy implanted in the human body. [7][8][9] The surface of stainless steel incorporates sulfur when it is implanted in soft tissue. 7 The surface oxide film of titanium implanted in the human jaw usually incorporates sulfur, and the authors suggest that sulfur probably originated from proteoglycans in the extracellular matrix. 8 The surface oxide film of Ti-6Al-4V alloy also incorporates sulfur in human bone marrow. 9 Therefore, the chemical environment at the interface between materials and cells must be different from that without cells.The prevention of diffusion and the precipitation of sulfite and/or sulfide indicate the formation of a reducing environment at the interface between metallic materials and cells. However, direct evaluation of the chemical property at the interface was not performed. Cells form a monolayer, as it were, a cell adhesive layer, on the surface of materials. In this study, pH values of the intracell layer and a few millimeters above the cell layer were measured using a tungsten microelectrode to characterize the chemical environment at the interface between metallic materials and cells. The obtained data may contribute t...

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Failures in stainless steel orthopaedic implant devices: A survey

Cited by 58 publications

References 6 publications

Mechanical behaviour of low-cost dynamic compression plates correlates with manufacturing quality standards

Mechanical behaviour of low-cost dynamic compression plates correlates with manufacturing quality standards

Premature fracture of a stainless steel 316L orthopaedic plate implant by alternative episodes of fatigue and cleavage decoherence

pH near Cells on Stainless Steel and Titanium

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