J Knee Surg 2017; 30(06): 594-599
DOI: 10.1055/s-0036-1593876
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Catastrophic Failure of Regenerex Tibial Components: A Case Series

Gavin Stormont
1   Department of Medical Education, University of Wisconsin–Madison School of Medicine and Public Health, Madison, Wisconsin
,
Daniel Stormont
2   Department of Orthopaedics, Memorial Hospital of Lafayette County, Darlington, Wisconsin
› Author Affiliations
Further Information

Publication History

14 August 2016

18 September 2016

Publication Date:
28 November 2016 (online)

Abstract

The aim of this study was to analyze short-term metal failures in well-placed Signature-guided Regenerex (Zimmer Biomet, Warsaw, IN) tibial components in a limited patient series. A retrospective, consecutive, nonrandomized, unblinded study from a limited cohort of young active osteoarthritis patients was conducted. All cases received a Regenerex tibial component which we evaluated for metal failure. Patients met the then current indications from the Center for Medicare and Medicaid Services Guidelines for knee replacement. Age, body mass index (BMI),and gender were compared between Regenerex and concurrent non-Regenerex knee arthroplasties. We identified a 4.7% (2 of 43) fracture rate in our Regenerex tibia replacements. Fractures occurred after 17 and 37 months, with a mean follow-up of 65 months (44–77). No statistical difference was seen in age or BMI between the fracture and nonfracture groups. Regenerex compared with standard arthroplasty patients were younger and predominantly male. Our inability to identify our fractures in the Food and Drug Administration (FDA) reporting site is concerning, suggesting additional cases may be unreported. A short-term Regenerex tibial fracture rate of 4.7% is unacceptably high. Inability to identify our fractures on the FDA Web site is a system failure, suggesting additional component fractures may be unreported.

Notes

The primary author (G.S.) gathered patient information and drafted report. The secondary author (D.S.) was principal surgeon and provided guidance and review in preparation of this report.


 
  • References

  • 1 Maradit Kremers H, Larson DR, Crowson CS. , et al. Prevalence of total hip and knee replacement in the United States. J Bone Joint Surg Am 2015; 97 (17) 1386-1397
  • 2 Daniele DO, Taubman SB, Clark LL. Incidence of joint replacement among active component service members, U.S. Armed Forces, 2004-2014. MSMR 2015; 22 (05) 2-8
  • 3 Singh JA, Vessely MB, Harmsen WS. , et al. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. Mayo Clin Proc 2010; 85 (10) 898-904
  • 4 Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. ClinOrthopRelat Res 2001; (392) 315-318
  • 5 Tanzer M, Makhdom AM. Preoperative planning in primary total knee arthroplasty. J Am AcadOrthopSurg 2016; 24 (04) 220-230
  • 6 Koh IJ, Cho WS, Choi NY. , et al. Causes, risk factors, and trends in failures after TKA in Korea over the past 5 years: a multicenter study. Clin Orthop Relat Res 2014; 472: 316-326
  • 7 Gilg MM, Zeller CW, Leitner L, Leithner A, Labek G, Sadoghi P. The incidence of implant fractures after knee arthroplasty. Knee Surg Sports TraumatolArthrosc 2016; 24 (10) 3272-3279
  • 8 Bozic KJ, Kurtz SM, Lau E. , et al; Clinical Orthopaedics and Related Research®. The epidemiology of revision total knee arthroplasty in the United States. ClinOrthopRelat Res 2010; 468 (01) 45-51
  • 9 Moreland JR. Mechanisms of failure in total knee arthroplasty. ClinOrthopRelat Res 1988; (226) 49-64
  • 10 Calliess T, Ettinger M, Hülsmann N, Ostermeier S, Windhagen H. Update on the etiology of revision TKA -- evident trends in a retrospective survey of 1449 cases. Knee 2015; 22 (03) 174-179
  • 11 Lombardi Jr AV, Berend KR, Adams JB. Why knee replacements fail in 2013: patient, surgeon, or implant?. Bone Joint J 2014; 96-B (11) , suppl A ): 101-104
  • 12 Helm AT, Kerin C, Ghalayini SR, McLauchlan GJ. Preliminary results of an uncemented trabecular metal tibial component in total knee arthroplasty. J Arthroplasty 2009; 24 (06) 941-944
  • 13 Kamath AF, Lee GC, Sheth NP, Nelson CL, Garino JP, Israelite CL. Prospective results of uncemented tantalum monoblock tibia in total knee arthroplasty: minimum 5-year follow-up in patients younger than 55 years. J Arthroplasty 2011; 26 (08) 1390-1395
  • 14 Hanssen A. Why the Future of Cementless TKR is Bright. VuMedi. 2016 . Available at: https://www.vumedi.com/video/why-the-future-of-cementless-tkr-is-bright/
  • 15 McGrory B, Weber K, Lynott JA. , et al; American Academy of Orthopaedic Surgeons. The American Academy of Orthopaedic Surgeons Evidence-Based Clinical Practice Guideline on surgical management of osteoarthritis of the knee. J Bone Joint Surg Am 2016; 98 (08) 688-692
  • 16 Ritter MA, Meneghini RM. Twenty-year survivorship of cementless anatomic graduated component total knee arthroplasty. J Arthroplasty 2010; 25 (04) 507-513
  • 17 No authors listed. Medicare Learning Network. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1236.pdf . Accessed March 1, 2016
  • 18 Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: patient expectations affect satisfaction with total knee arthroplasty. ClinOrthopRelat Res 2006; 452 (452) 35-43
  • 19 Motififard M, Pesteh M, Etemadifar MR, Shirazinejad S. Causes and rates of revision total knee arthroplasty: local results from Isfahan, Iran. Adv Biomed Res 2015; 4: 111
  • 20 Gudnason A, Hailer NP, W-Dahl A, Sundberg M, Robertsson O. All-polyethylene versus metal-backed tibial components-an analysis of 27,733 cruciate-retaining total knee replacements from the Swedish Knee Arthroplasty Register. J Bone Joint Surg Am 2014; 96 (12) 994-999
  • 21 Kasahara Y, Majima T, Kimura S, Nishiike O, Uchida J. What are the causes of revision total knee arthroplasty in Japan?. ClinOrthopRelat Res 2013; 471 (05) 1533-1538
  • 22 Siqueira MB, Klika AK, Higuera CA, Barsoum WK. Modes of failure of total knee arthroplasty: registries and realities. J Knee Surg 2015; 28 (02) 127-138
  • 23 Kohan L, Field C, Kerr D. Early failure of the uncemented Biomet Vanguard tibial component. Bone Joint J 2013; 95-B (Suppl. 15) 103
  • 24 No authors listed. MAUDE FDA. Website. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm . Accessed March 1, 2016
  • 25 Chapman RM, Mayor MB, Van Critter D. Joint Retrieval Registry does not represent U.S. population for Primary Reason for Revision in Total Knee Arthroplasty. AAOS Annual Meeting; 2016
  • 26 Pabinger C, Lumenta DB, Cupak D, Berghold A, Boehler N, Labek G. Quality of outcome data in knee arthroplasty. Acta Orthop 2015; 86 (01) 58-62
  • 27 Bin AbdRazak HR, Tan C-S, Chen YJD. , et al. Age and preoperative Knee Society score are significant predictors of outcomes among Asians following total knee arthroplasty. J Bone Joint Surg Am 2016; 98 (09) 735-741
  • 28 Meneghini RM, de Beaubien BC. Early failure of cementless porous tantalum monoblock tibial components. J Arthroplasty 2013; 28 (09) 1505-1508
  • 29 da Palma IM, Albuquerque RP, Barretto JM. Fracture of the tibial component in total knee arthroplasty: report on two cases. Rev Bras Ortop 2015; 46 (03) 325-328
  • 30 Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi Jr AV. ; Clinical Orthopaedics and Related Research®. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. ClinOrthopRelat Res 2012; 470 (01) 99-107
  • 31 Spencer BA, Mont MA, McGrath MS, Boyd B, Mitrick MF. Initial experience with custom-fit total knee replacement: intra-operative events and long-leg coronal alignment. IntOrthop 2009; 33 (06) 1571-1575
  • 32 Lachiewicz PF, Henderson RA. Patient-specific instruments for total knee arthroplasty. J Am AcadOrthopSurg 2013; 21 (09) 513-518
  • 33 Goyal T, Tripathy SK. Doespatient-specific instrumentations improve short-term functional outcomes after total knee arthroplasty? A systematic review and meta-analysis. J Arthroplasty 2016; 31 (10) 2173-2180
  • 34 Nam D, Vajapey S, Nunley RM, Barrack RL. The impact of imaging modality on the measurement of coronal plane alignment after total knee arthroplasty. J Arthroplasty 2016; 31 (10) 2314-2319
  • 35 Noble Jr JW, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty 2012; 27 (01) 153-155
  • 36 Nunley RM, Ellison BS, Zhu J, Ruh EL, Howell SM, Barrack RL. Do patient-specific guides improve coronal alignment in total knee arthroplasty?. ClinOrthopRelat Res 2012; 470 (03) 895-902
  • 37 Skyttä ET, Haapamäki V, Koivikko M, Huhtala H, Remes V. Reliability of the hip-to-ankle radiograph in determining the knee and implant alignment after total knee arthroplasty. Acta OrthopBelg 2011; 77 (03) 329-335
  • 38 Kumar N, Yadav C, Raj R, Anand S. How to interpret postoperative X-rays after total knee arthroplasty. OrthopSurg 2014; 6 (03) 179-186
  • 39 Colebatch AN, Hart DJ, Zhai G, Williams FM, Spector TD, Arden NK. Effective measurement of knee alignment using AP knee radiographs. Knee 2009; 16 (01) 42-45