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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)

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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.

Keywords

knee - arthroplasty - failure - Regenerex

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.