Dataset Information
Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.
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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.
SUBMITTER: Koch CN
PROVIDER: S-EPMC5026663 | biostudies-literature | 2016 Oct
REPOSITORIES: biostudies-literature
Publications
Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.
HSS journal : the musculoskeletal journal of Hospital for Special Surgery 20160621 3
<h4>Background</h4>Femoral stem fracture following total hip arthroplasty is an uncommon event that requires immediate revision surgery.<h4>Questions/purposes</h4>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.<h4>Methods</h4>Fracture surfaces of four EMPERION™ (Smith & Nephew, Memphis, TN) femoral stems were analyzed under optical and scanning electron microscopy. A search of the FD ...[more]