Response to: Confidence in the ATTUNE Knee is Driven by Real-World Scientific Evidence: Response to Bonutti et al. Article

In a letter to clinicians dated June 14, 2017 (“the DePuy Letter”),[1] Dr. Daniel Funk (US Franchise Medical Director for DePuy Synthes) and Mr. Joshua Bridgens (EMEA Franchise Medical Director for DePuy Synthes) wrote a four-page commentary on the article published in the Journal of Knee Surgery using terms such as “inaccurate” and “misleading” and provided 19 references to support their letter.[2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] This is a response to this DePuy commentary.

The article by Bonutti et al points to design issues in the DePuy ATTUNE tibial baseplate DePuy Synthes which may lead to early failure of the tibial component (i.e., cement debonding at the tibial implant cement interface at short-term follow-up). It identifies 15 cases of catastrophic tibial component debonding with tibial component pistoning off the cement mantle and failure of cement fixation to the tibial implant. In these cases, the tibia could simply be lifted off the cement mantle manually ([Figs. 1] [2] [3]). The authors of this article identified several possible design deficiencies, which could contribute to early failure, and these appear to have been confirmed by DePuy's recent launch of the ATTUNE S+ tibia for their fixed bearing system. The ATTUNE RP tibia may also have issues with cement fixation and we have identified severe backside polyethylene wear in this revision series ([Figs. 4] and [5]).

Fig. 1 ATTUNE Rotating Platform baseplate.

Fig. 2 Backside of baseplate. No polymethyl methacrylate fixation.

Fig. 3 Tibial cement mantle completely intact. Implant loose and pistoning off cement.

Fig. 4 Backside of poly bearing. Severe erosions, wear, and pitting.

Fig. 5 Additional view of backside poly wear.

• References

• 1 Funk DA, Bridgens J. Confidence in the ATTUNE knee is driven by real-world scientific evidence: response to Bonutti et al. article. Available at: http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Journal%20Articles/CERT%20Attune%20WP%20Response%20to%20Bonutti.pdf . Accessed December 14, 2017
• 2 Bonutti PM, Khlopas A, Chughtai M. , et al. Unusually high rate of early failure of tibial component in ATTUNE total knee arthroplasty system at implant-cement interface. J Knee Surg 2017; 30 (05) 435-439
• 3 Abdel MP, Bonadurer III GF, Jennings MT, Hanssen AD. Increased aseptic tibial failures in patients with a BMI ≥35 and well-aligned total knee arthroplasties. J Arthroplasty 2015; 30 (12) 2181-2184
• 4 Richardson G, Turgeon T, Gascoyne T, Laende E, Bohm E, Dunbar M. Stability assessment of a new knee replacement product using radiostereometric analysis. Poster Presentation at the Canadian Orthopaedic Association Meeting, Ottawa, Ontario, June 15–18, 2017
• 5 Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2016). Tables KT9 and KT22. Available at: https://aoanjrr.sahmri.com/ documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20 . Accessed September, 2017
• 6 Billi F, Kavanaugh A, Schmalzried H, Schmalzried T. Factor influencing the initial strength of the tibial tray-PMMA cement bond. ORS 2014 Annual Meeting, 2014; Poster Number 1854
• 7 U.S. Food and Drug Administration (FDA). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM . Accessed September 2017
• 8 Hazelwood KJ, O'Rourke M, Stamos VP, McMillan RD, Beigler D, Robb III WJ. Case series report: early cement-implant interface fixation failure in total knee replacement. Knee 2015; 22 (05) 424-428
• 9 Maag C, Peckenpaugh E, Metcalf A. , et al. Influence of intra-operative lipid/marrow infiltration and intra- operative motions upon cemented tibial implant fixation. Poster # 1239, EFORT, Vienna, Austria, 2017
• 10 Kopinski JE, Aggarwal A, Nunley RM, Barrack RL, Nam D. Failure at the tibial cement-implant interface with the use of high-viscosity cement in total knee arthroplasty. J Arthroplasty 2016; 31 (11) 2579-2582
• 11 National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 13th Annual Report, 2016; Table 3.28. Available at: http://www-new.njrcentre.org.uk/njrcentre/Default.aspx . Accessed September, 2017
• 12 National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Summary Report for DePuy ATTUNE CR and ATTUNE PS. NJR Database extract April 7, 2017:1–17. Licensed for use until April 19, 2018. Available at: www.attuneevidence.com and www.provingthepromise.com . Accessed September, 2017
• 13 Pijls BG, Valstar ER, Nouta KA. , et al. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop 2012; 83 (06) 614-624
• 14 Sharkey PF, Lichstein PM, Shen C, Tokarski AT, Parvizi J. Why are total knee arthroplasties failing today--has anything changed after 10 years?. J Arthroplasty 2014; 29 (09) 1774-1778
• 15 Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty 2013; 28 (05) 714-721
• 16 Gebert de Uhlenbrock A, Püschel V, Püschel K, Morlock MM, Bishop NE. Influence of time in-situ and implant type on fixation strength of cemented tibial trays - a post mortem retrieval analysis. Clin Biomech (Bristol, Avon) 2012; 27 (09) 929-935
• 17 Vyskocil P, Gerber C. Bamert P. Radiolucent lines and component stability in knee arthroplasty. Standard versus fluoroscopically-assisted radiographs. J Bone Joint Surg Br 1999; 81-B (01) 24-26
• 18 Hamilton WG, Brenkel I, Clatworthy M. , et al. Early patient-reported outcomes with primary vs contemporary total knee arthroplasty: a comparison of two worldwide multi-center prospective studies. Presentation at the International Society for Technology in Arthroplasty (ISTA), San Diego, CA, March 2016. Poster 106
• 19 Ryd L, Albrektsson BE, Carlsson L. , et al. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br 1995; 77 (03) 377-383
• 20 Martin JR, Watts CD, Levy DL. , et al. Tibial tray thickness significantly increases medial tibial bone resorption in cobalt-chromium total knee arthroplasty implants. J Arthroplasty 2017; 32: 79-82
• 21 National Joint Registry. NJR Supporting Data Quality. Available at: http://www.njrcentre.org.uk/njrcentre/Portals/0/Documents/England/Data quality and strategy/NJR Supporting data quality - strategy 14-16 online.pdf . Accessed November 29, 2017