The DePuy ASR hip implant systems had exceptionally high Cumulative Percent Revision compared with other implants in Australia. This was likely to be the case worldwide and thus the ASR hip implant systems were voluntarily withdrawn by DePuy on August 24, 2010. To avoid such debacles in future implant systems, it is instructive for biotribologists to examine the warnings provided by hip wear simulator testing prior to market release circa 2004. The ASR hip implants had metal-on-metal bearings that had shown some success in other designs. Based on hip wear simulator studies of these designs (mostly having 28 mm diameter heads), a Safe Zone for Wear Rates versus Implantation Time could be defined. However, some of the earlier metal-on-metal designs were wear simulator tested under some harsher clinically relevant conditions. They missed the Safe Zone thus confirming a biotribological risk for ASR hip implant systems. Subsequent analysis after market release of the ASR implants confirmed that the risk had been underestimated. Biotribological risk for new implant designs should be examined rigorously prior to market release.
IsaacGHSiebelTSchmalzriedTP, et al. Development rationale for an articular surface replacement: a science-based evolution. Proc IMechE, Part H: J Engineering in Medicine2006; 220(2): 253–263.
ASTM F75 – 07. Standard specification for cobalt-28 chromium-6 molybdenum alloy castings and casting alloy for surgical implants (UNS R30075). ASTM International, 2007. DOI: 10.1520/F0075-07.
6.
ASR total conventional hip investigation. Table 2. https://aoanjrr.sahmri.com/annual-reports-2023 . Click on “Prosthesis Investigations” then “Hips” then “Total Hips” then “Total Conventional Hip” then “Identified and no longer used” and finally on page 3 “ASR Acetabular 2023” (2023, accessed 9 May 2024).
7.
ASR/ASR total resurfacing hip investigation. Table 2. https://aoanjrr.sahmri.com/annual-reports-2023 . Click on “Prosthesis Investigations” then “Hips” then “Total Hips” then “Total Resurfacing Hip” then “Identified and no longer used” and finally on “ASR & ASR Combination 2023” (2023, accessed 9 May 2024).
8.
FisherJ.Bioengineering reasons for the failure of metal-on-metal hip prostheses – an engineer’s perspective. J Bone Joint Surg Br2011; 93(8): 1001–1004.
9.
JinZMMeakinsSMorlockMM, et al. Deformation of press-fitted metallic resurfacing cups. Part 1: experimental simulation. Proc IMechE, Part H: J Engineering in Medicine2006; 220(2): 299–309.
10.
MedleyJB.Can physical joint simulators be used to anticipate clinical wear problems of new joint replacement implants prior to market release?Proc IMechE, Part H: J Engineering in Medicine2016; 230(5): 347–358.
11.
De SmetKDe HaanRCalistriA, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am2008; 90: 202–208.
12.
KwonY-MGlyn-JonesSSimpsonDJ, et al. Analysis of wear of retrieved metal-on-metal hip resurfacing implants revised due to pseudotumours. JBone Joint Surg Br2010; 92(3): 356–361.
13.
GrammatopoulosGPanditHKamaliA, et al. The correlation of wear with histological features after failed hip resurfacing arthroplasty. J Bone Joint Surg Am2013; 95(1–10): e81.
14.
HailerNPBengtssonMLundbergC, et al. High metal ion levels after use of the ASRTM device correlate with development of pseudotumors and T cell activation. Clin Orthop Relat Res2014; 472(3): 953–961.
15.
LangtonDJJoyceTJJamesonSS, et al. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br2011; 93(2): 164–167.
16.
MatthiesAKSkinnerJAOsmaniH, et al. Pseudotumors are common in well-positioned low-wearing metal-on-metal hips. Clin Orthop Relat Res2012; 470(7): 1895–1906.
17.
EbramzadehECampbellPTanTL, et al. Can wear explain the histological variation around metal-on-metal total hips?Clin Orthop Relat Res2015; 473(2): 487–494.
18.
ParkS-HLuZHastingsRS, et al. Five hundred fifty-five retrieved metal-on-metal hip replacements of a single design show a wide range of wear, surface features, and histopathologic reactions. Clin Orthop Relat Res2018; 476(2): 261–278.
19.
LangtonDJSidaginamaleRPJoyceTJ, et al. Aseptic lymphocyte-dominated vasculitis-associated lesions are related to changes in metal ion handling in the joint capsules of metal-on-metal hip arthroplasties. Bone Jt Res2018; 7(6): 388–396.
20.
GranchiDSavarinoLMCiapettiG, et al. Biological effects of metal degradation in hip arthroplasties. Crit Rev Toxicol2018; 48(2): 170–193.
21.
SilvaMShepherdEFJacksonWO, et al. Average patient walking activity approaches 2 million cycles per year – pedometers under-record walking activity. J Arthroplasty2002; 17(6): 693–697.
22.
DorrLDLongWTSirianniL, et al. The argument for the use of Metasul as an articulation surface in total hip replacement. Clin Orthop Relat Res2018; 429: 80–85.
23.
MedleyJBChanFWKrygierJJ, et al. Comparison of alloys and designs in a hip simulator study of metal on metal implants. Clin Orthop Relat Res1996; 329: S148–S159.
24.
ChanFWBobynJDMedleyJB, et al. Engineering issues and wear performance of metal on metal hip implants. Clin Orthop Relat Res1996; 333(333): 96–107.
25.
MedleyJBDowlingJMPoggieRA, et al. Simulator wear of some commercially available metal-on-metal hip implants. In: JacobsJJCraigTL (eds) Alternative bearings surfaces in total joint replacement (STP 1346). West Conshohocken, PA: ASTM International, 1998, pp.92–110.
26.
ChanFWBobynJDMedleyJB, et al. Wear and lubrication of metal-on-metal hip implants. Clin Orthop Relat Res1999; 369(369): 10–24.
27.
GoldsmithAAJDowsonDIsaacGH, et al. A comparative joint simulator study of the wear of metal-on-metal and alternative material combinations in hip replacements. Proc IMechE, Part H: J Engineering in Medicine2000; 214(1): 39–47.
28.
ScholesSCGreenSMUnsworthA.The wear of metal-on-metal total hip prostheses measured in a hip simulator. Proc IMechE, Part H: J Engineering in Medicine2001; 215(6): 523–530.
29.
FirkinsPJTipperJLSaadatzadehMR, et al. Quantitative analysis of wear and wear debris from metal-on-metal hip prostheses tested in a physiological hip joint simulator. Biomed Mater Eng2001; 11(1): 143–157.
30.
FirkinsPJTipperJLInghamE, et al. A novel low wearing differential hardness, ceramic-on-metal hip joint prosthesis. J Biomech2001; 34(10): 1291–1298.
31.
WilliamsSStewartTDInghamE, et al. Metal-on-metal bearing wear with different swing phase loads. J Biomed Mater Res B Appl Biomater2004; 70(2): 233–239.
32.
DowsonDHardakerCFlettM, et al. A hip joint simulator study of the performance of metal-on-metal joints: part II: design. J Arthroplasty2004; 19(8Suppl. 3): 124–130.
33.
FarrarRSchmidtMB. The effect of diametral clearance on wear between head and cup for metal on metal articulations. In: Proceedings of the 43rd annual meeting of the orthopaedic research society (Paper 71-12), San Francisco, CA, 9–13 February 1997. Rosemont, IL: ORS.
34.
ReinischGJudmannKPLhotkaC, et al. Retrieval study of uncemented metal-metal hip prostheses revised for early loosening. Biomath (Sofia)2003; 24(6): 1081–1091.
35.
RiekerCBSchönRKöttigP.Development and validation of a second-generation metal-on-metal bearing: laboratory studies and analysis of retrievals. J Arthroplasty2004; 19(8Suppl. 3): 5–11. Personal email sent to current author by Dr. Claude Rieker regarding data in his publication.
36.
ButterfieldMStewartTWilliamsS, et al. Wear of metal-metal and ceramic-ceramic hip prostheses with swing phase microseparation. In: Proceedings of the 48th annual meeting of the orthopaedic research society (Paper 128), Dallas, TX, 10–13 February 2002. Rosemont, IL: ORS.
37.
NevelosJInghamEDoyleC, et al. Microseparation of the centers of alumina-alumina artificial hip joints during simulator testing produces clinically relevant wear rates and patterns. J Arthroplasty2000; 15(6): 793–795.
38.
ChanFWBobynJDMedleyJB, et al. Simulator wear of metal-metal hip implants under adverse load conditions. In: Proceedings of the 45th annual meeting of the orthopaedic research society, Anaheim, CA, 1–4 February 1999. Rosemont, IL: ORS.
39.
FisherJInghamEMatthewsB, et al. Functional biological activity and osteolytic potential of wear debris generated in artificial hip joints. In: International conference: Engineers & surgeons – joined at the hip. Refining future strategies in total hip replacement, (Paper C601/011/2002), Savoy Place, London, UK, 13–15 June 2002. IMechE.
40.
WilliamsSLeslieIIsaacG, et al. Tribology and wear of metal-on-metal hip prostheses: influence of cup angle and head position. J Bone Joint Surg Am2008; 90: 111–117.
41.
LeslieIJWilliamsSIsaacG, et al. High cup angle and microseparation increase the wear of hip surface replacements. Clin Orthop Relat Res2009; 467(9): 2259–2265.
42.
LordJKLangtonDJNargolAVF, et al. Volumetric wear assessment of failed metal-on-metal hip resurfacing prostheses. Wear2011; 272(1): 79–87.
43.
LeslieIWilliamsSBrownC, et al. Effect of bearing size on the long-term wear, wear debris, and ion levels of large diameter metal-on-metal hip replacements: an in vitro study. J Biomed Mater Res B Appl Biomater2008; 87(1): 163–172.
44.
WilliamsSJalali-VahidDJinZM, et al. Effect of swing phase load conditions on the wear, friction and lubrication in metal-on-metal hips. In: Proceedings of the 50th annual meeting of the orthopaedic research society, (Paper 0122), San Francisco, CA, 7–10 March 2004. Rosemont, IL: ORS.
45.
DonellSTDarrahCNolanJF, et al.; Norwich Metal-on-Metal Study Group. Early failure of the ultima metal-on-metal total hip replacement in the presence of normal plain radiographs. J Bone Joint Surg Br2010; 92-B(11): 1501–1508.
46.
JinZMMedleyJBDowsonD.Fluid film lubrication in artificial hip joints. Tribol Ser41: 237–256. Tribological research and design for engineering systems, Ed. DowsonDPriestMDalmazGLubrechtAA. Proc of the 29th Leeds-Lyon Symposium on Tribology, Bodington Hall, University of Leeds, 3–6 September 2002.
47.
Australian orthopaedic association national joint replacement registry – 2018 annual report. Revision:page 29. https://aoanjrr.sahmri.com/annual-reports-2018. Click on “Hip, Knee & Shoulder Arthroplasty Annual Report” (accessed 10 July 2024).
48.
Bionik/bionik total resurfacing hip investigation 2022. Table 2. https://aoanjrr.sahmri.com/annual-reports-2023. Click on “Prosthesis Investigations” then “Hips” then “Total Hips” then “Total Resurfacing Hip” then “Identified and no longer used” and finally “Bionik & Bionik Combination 2023” (accessed 10 July 2024).
49.
Bionik total conventional hip investigation 2022. Table 2. https://aoanjrr.sahmri.com/annual-reports-2023. Click on “Prosthesis Investigations” then “Hips” then “Total Hips” then “Total Conventional Hip” then “Identified and no longer used” and finally “Bionik & Bionik Acetabular 2023” (accessed 10 July 2024).
50.
Cormet/Cormet total resurfacing hip investigation 2022. Table 2. https://aoanjrr.sahmri.com/annual-reports-2023. Click on “Prosthesis Investigations” then “Hips” then “Total Hips” then “Total Resurfacing Hip” then “Identified and no longer used” and finally “Cormet & Cormet Combination 2023” (accessed 10 July 2024).
51.
BHR total conventional hip investigation 2022. Table 2. https://aoanjrr.sahmri.com/annual-reports-2023. Click on “Prosthesis Investigations” then “Hips” then “Total Hips” then “Total Conventional Hip” then “Identified and no longer used” and finally “BHR Acetabular 2023” (accessed 10 July 2024).
52.
Australian orthopaedic association national joint replacement registry – 2023 annual report. Table HT84:page 201. https://aoanjrr.sahmri.com/annual-reports-2018. Click on “Hip, Knee & Shoulder Arthroplasty Annual Report” (accessed 10 July 2024).
53.
Australian orthopaedic association national joint replacement registry – 2023 annual report. Table HT38:page 155. https://aoanjrr.sahmri.com/annual-reports-2018. Click on “Hip, Knee & Shoulder Arthroplasty Annual Report” (accessed 10 July 2024).
54.
Australian orthopaedic association national joint replacement registry – 2023 annual report. Bearing Surface:page 145. https://aoanjrr.sahmri.com/annual-reports-2018. Click on “Hip, Knee & Shoulder Arthroplasty Annual Report” (accessed 10 July 2024).
