Standards We Test
Implants for surgery — Retrieval and analysis of surgical implants
Service Overview
Performing implant retrieval analyses can improve the clinical outcome of total joint replacements as well as determine the cause of failure (or success) for a particular implant system or model. Implant retrieval analysis is also beneficial for medical device development to advance implant design in the areas needed.
OIC’s Biomedical Engineers provide contracted implant retrieval analysis services for single cases or multiple device series. We specialize in:
- Objective, third-party analysis of implant failure mode, visible damage, and material assessment for legal proceedings
- Systematic evaluation of an implant series to determine patterns of wear, damage, and failure
Available analysis methods:
- Explant handling, processing, and analysis (1)
- Observer damage scoring of polyethylene (2), metal (3), ceramic (4), ceramicized-metal (5), and taper junctions (6)
- SEM imaging combined with EDS for microscopic evaluation of observed damage and surface wear, fracture mechanisms, and material composition
- Contact profilometry to measure post-implantation surface roughness and evaluate topographical changes on articular surfaces due to damage
- CMM measurement of articulation wear (7) (8) (9)
- CMM measurement of material loss on tapered junctions (9, 10)
- CMM measurement for device dimensional inspection (8)
- Volumetric wear analysis of articulating components through reverse engineering (5, 12)
Additional Information
Can your analyses be used in legal proceedings?
Our retrieved device analysis services will provide a complete and non-biased review of the damage, wear, and failure modes observed on the device but we are not able to provide direct interpretation of these results. Our focus is to perform state-of-the-art analysis and to report our findings, which may be used for legal cases, however the OIC is not structured to provide expert witness services and/or testimony.
Can you perform an internal review of your retrievals for an external client?
Performing contracted implant retrieval analyses is a backbone of our service offering. OIC Engineers will work with interested clients to establish an analysis protocol for a defined device or device-type that exists in our database. Our implant retrieval database is the largest in Western Canada with over 4000 retrieved joint replacements. Visit here for more information.
Do you publish your retrieved device analyses?
The decision to pursue publication is up to the client, as it can be a lengthy and challenging task in which success cannot be guaranteed. We have published a number of retrieval analysis studies. Please see our Publications page for more information.
References
- ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
- Hood, R. W., et al. “Retrieval Analysis of Total Knee Prostheses: A Method and Its Application to 48 Total Condylar Prostheses,” J. Biomed. Mater. Res., Vol. 17, No. 5, 1983, pp. 829–842 (https://pubmed.ncbi.nlm.nih.gov/6619179/)
- McKellop HA, et al. A lexicon for wear of metal-on-metal hip prostheses. J Orthop Res. 2014;32(9):1221-33 (https://pubmed.ncbi.nlm.nih.gov/24844814/)
- Brandt JM et al. Clinical failure analysis of contemporary ceramic-on-ceramic total hip replacements. 2014. Proc Inst Mech Eng Part H. Volume: 227 issue: 8, page(s): 833-846. (https://pubmed.ncbi.nlm.nih.gov/23736992/)
- Gascoyne TC et al. In vivo wear performance of cobalt-chromium versus oxidized zirconium femoral total knee replacements. J Arthroplasty. Jan; 31(1):137-41. (https://pubmed.ncbi.nlm.nih.gov/26424405/)
- Goldberg, JR; et al. A Multicenter Retrieval Study of the Taper Interfaces of Modular Hip Prostheses. Clin Orthop Relat Res: 2002 – 401: 149-161 (https://pubmed.ncbi.nlm.nih.gov/12151892/)
- ASTM F2979-14 Standard guide for characterization of wear from the articulating surfaces in retrieved metal-on-metal and other hard-on-hard prostheses
- Gascoyne TC, et al. Damage Assessment of Retrieved Birmingham Monoblock Cups: Is Conversion to Dual-Mobility Head a Viable Revision Option? J Arthroplasty. 2018;33(4):1242-6. (https://pubmed.ncbi.nlm.nih.gov/29276120/)
- Gascoyne TC et al. Retrieval Analysis of Large-Head Modular Metal-on-Metal Hip Replacements of a Single Design. J Arthroplasty. 2018 June;33(6):1945-1952. (https://pubmed.ncbi.nlm.nih.gov/29402714/)
- ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
- ASTM F2033-12 Standard specification for total hip joint prosthesis and hip endoprosthesis bearing surfaces made of metallic, ceramic, and polymeric materials
- Lord JK, Langton DJ, Nargol AVF, Joyce TJ. Volumetric wear assessment of failed metal-on-metal hip resurfacing prostheses. Wear. 2011;272(1):79-87. (https://www.sciencedirect.com/science/article/abs/pii/S004316481100528X)