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

Abstract

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. 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. 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. 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.