This presentation briefly describes the capabilities of the BPAL in the analysis and characterization of wear debris and metal ions

1. Wear Debris Isolation and Characterization The J. Vernon Luck, Sr., M.D., Orthopaedic Research Center Orthopaedic Hospital, Los Angeles

3. Optimized density gradient centrifugation

4. Complete separation of particles from organic contaminants

5. Negligible level of artifactual agglomerates

6. Applicable to most materials

7. Suitable for simultaneous separation of coexisting particles of different materials (for example PE and CoCr)

10. Excellent monetary value

11. Particles classified by ECD, number and volume

12. Well-suited for homogeneous samples:

13. low level of contaminants

16. Excellent monetary value

17. Particles classified by ECD, number and volume

18. Qualitative SEM/EDS analysis

19. Well-suited for homogeneous samples:

20. low level of contaminants

22. > 90% particle recovery rate

23. Even dispersion of particles on Si waferEnzyme-Digested Sample Particles (density<2.0) Protein Fragments (density<2.0) Sample r = 1.1 g/cc (average density) Denaturant Layer (density 1.25 g/cc) Barrier Layer (density 2.0 g/cc) Si Wafer or TEM Grid Tube Plug (density= 2.2 g/cc) 1 Recognized with the 2011 John Charnley Award, The Hip Society

25. Excellent particle-background contrast

26. Accurate chemical identification via EDS

27. Semi-automated particle analysis (shape, size, chemical ID)

28. 3D reconstruction of particle shape and volume – available on request

29. Well-suited for non-homogeneous samples:

30. high level of contaminants

32. MOPE – HIP – Bovine Serum 95% + NaN3 1 µm Arrows indicate nanometer-size particles

34. Total Load (free ions + particles)

35. Cr speciation [Cr (III) vs. Cr(VI)] - available on request

37. All electronic data encrypted with 256-bit key on two separate hard drives (one mirroring the other) and copied to DVD.

38. All data, documents, and samples preserved for five years unless otherwise specified.

39. Morphological characterization used in the Advanced Protocol exceeds ISO and ASTM standards.

41. Weekly updates on the status of the analysis.

42. Where applicable, intermediate report.

43. Final report delivered via e-mail and on DVD.

45. Contact Fabrizio Billi, Ph.D. Director, Biomaterials and Particle Analysis Laboratory The J. Vernon Luck Sr., M.D., Orthopaedic Research Center at Orthopaedic Hospital Orthopaedic Hospital 2400 South Flower Street Lowman Building - 5th FloorLos Angeles, CA 90007-2629 office: +1 213 742 1352 Cell: +1 424 442 0364 fax: + 1 213 742 1090 e-mail: fb@orthopaedicparticleanalysis.com www.orthopaedicparticleanalysis.com