A simulator study of adverse wear with metal and cement debris contamination in metal-on-metal hip bearings

T Halim; I C Clarke; M D Burgett-Moreno; T K Donaldson; C Savisaar; J G Bowsher

doi:10.1302/2046-3758.43.2000332

A simulator study of adverse wear with metal and cement debris contamination in metal-on-metal hip bearings

Bone Joint Res. 2014 Mar;4(3):29-37. doi: 10.1302/2046-3758.43.2000332.

Authors

T Halim¹, I C Clarke¹, M D Burgett-Moreno¹, T K Donaldson¹, C Savisaar², J G Bowsher²

Affiliations

¹ Loma Linda University, 900 E Washington St, Suite 200, Colton, 92324, California, USA.
² Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, USA.

Abstract

Objectives: Third-body wear is believed to be one trigger for adverse results with metal-on-metal (MOM) bearings. Impingement and subluxation may release metal particles from MOM replacements. We therefore challenged MOM bearings with relevant debris types of cobalt-chrome alloy (CoCr), titanium alloy (Ti6Al4V) and polymethylmethacrylate bone cement (PMMA).

Methods: Cement flakes (PMMA), CoCr and Ti6Al4V particles (size range 5 µm to 400 µm) were run in a MOM wear simulation. Debris allotments (5 mg) were inserted at ten intervals during the five million cycle (5 Mc) test.

Results: In a clean test phase (0 Mc to 0.8 Mc), lubricants retained their yellow colour. Addition of metal particles at 0.8 Mc turned lubricants black within the first hour of the test and remained so for the duration, while PMMA particles did not change the colour of the lubricant. Rates of wear with PMMA, CoCr and Ti6Al4V debris averaged 0.3 mm(3)/Mc, 4.1 mm(3)/Mc and 6.4 mm(3)/Mc, respectively.

Conclusions: Metal particles turned simulator lubricants black with rates of wear of MOM bearings an order of magnitude higher than with control PMMA particles. This appeared to model the findings of black, periarticular joint tissues and high CoCr wear in failed MOM replacements. The amount of wear debris produced during a 500 000-cycle interval of gait was 30 to 50 times greater than the weight of triggering particle allotment, indicating that MOM bearings were extremely sensitive to third-body wear. Cite this article: Bone Joint Res 2015;4:29-37.

Keywords: 3rd-body abrasion; Hip arthroplasty; metal-on-metal; simulator; wear.

Grants and funding

This MOM retrieval study was supported by an FDA contract ‘Development and Validation of Improved Premarket Testing methods (simulator studies) for Metal-on-Metal (MOM) Hip Replacements’ (FD-1090372). Thanks are due to the DJO Group (Austin, Texas) for donation of the MOM implants used in this study. Funds have also been received by the FDA from Critical Path Funding to assist with this study. I. C. Clarke has received funding from Stryker, WMT and Biomet Japan, none of which is related to this article.