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HSS J. 2016 Oct;12(3):250-254. Epub 2016 Jun 21.

Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.

Author information

1
Department of Biomechanics, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021 USA.
2
Orthopaedic and Trauma Surgery, Hospital Clinico San Carlos, Madrid, 28040 Spain.
3
University Orthopaedic Associates, Somerset, NJ 08873 USA.
4
Orthopaedic Associates of Manhasset, P.C., General Orthopedics, Great Neck, NY 11021 USA.
5
Adult Reconstruction and Joint Replacement Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY 10021 USA.

Abstract

BACKGROUND:

Femoral stem fracture following total hip arthroplasty is an uncommon event that requires immediate revision surgery.

QUESTIONS/PURPOSES:

We report on four patients who experienced stem fractures of one design and a review of the US Food and Drug Administration adverse event reports on this design.

METHODS:

Fracture surfaces of four EMPERION™ (Smith & Nephew, Memphis, TN) femoral stems were analyzed under optical and scanning electron microscopy. A search of the FDA's Manufacturer and User Facility Device Experience (MAUDE) that reports on all EMPERION™ adverse events was completed.

RESULTS:

Fracture surfaces exhibited characteristics consistent with a fatigue fracture mechanism. Sixteen MAUDE reports claimed stem fracture or breakage of EMPERION™ stems.

CONCLUSION:

The four cases of EMPERION™ stem fractures were likely driven by small stem diameter, high offset, and high patient weight. Modular stem-sleeve femoral systems are susceptible to fatigue failure under high stress and should only be used in appropriate patients, whom are not considered obese.

KEYWORDS:

modular stem; stem fracture; total hip arthroplasty; uncemented

Conflict of interest statement

Compliance with Ethical Standard Conflict of Interest Chelsea N. Koch, BS, Laura Serrano Mateo, MD, and Kevin A. Cassidy, MD have declared that they have no conflict of interest. Stephen Kayiaros, MD reports personal fee from Depuy and other from Pfizer, outside the work. Seth A. Jerabek, MD reports personal fees from Stryker, outside the work. Alejandro Gonzalez Della Valle, MD reports personal fees from OrthoSensor, Ortho Development, and Link Bio, outside the work. Human/Animal Rights All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed Consent Informed consent was obtained from all patients for being included in the study. Required Author Forms Disclosure forms provided by the authors are available with the online version of this article.

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