High rates of implant fracture of a generic polished tapered femoral stem

Abstract

Objectives: Cemented polished tapered stems have demonstrated excellent long-term outcomes. Based on this concept, many generic tapered stems have been released into the market. The aim of this study was to evaluate implant-related complications of 1 specific stem design. Methods: Between 2010 and 2017, 315 total hip replacements were performed using a Fortress stem (Biotechni, La Ciotat, France). Patient records and radiology were retrospectively reviewed for implant-related complications. A failure analysis was performed on the failed Fortress stems in order to determine the cause of premature failure. Results: 7 (2.2%) patients sustained a fracture of the neck of the implant after a mean of 5 years (range 50–81 months). All fractures were atraumatic, originating at the introducer inlet of the stem. All fractured occurred in obese patients (BMI >33 kg/m2) with a small sized prosthesis. Of these, there were 5 135° and 2 125° stems. Fracture risk was 23% (7/30) for patients with a small sized stem and a BMI >30 kg/m2. All cases were revised using a cement-in-cement technique or a cementless modular revision stem. Failure analysis on the retrieved stems revealed a stress riser at the bottom of the introducer inlet. Conclusions: An alarmingly high rate of early implant fractures was seen using this specific type of cemented stem, particularly when using smaller implant sizes in obese patients. Although based on a proven design, a specific modification led to a stress riser in the neck area, which resulted in a high incidence of implant failure. This series underlines the importance of a stepwise introduction into the market of new orthopaedic devices even when based on established concepts. Generic stems may not behave as the original stem upon which it was designed.