Daniel Kluess, Hans-E. Lange, Horst Heyer, Manuela Sander, Wolfram Mittelmeier, Rainer Bader
November 15, 2018
Before an implantable medical device passes market clearance, a number of mechanical tests need to be conducted in order to verify the mechanical safety of the product. With regard to total hip replacement stems, these are subject to fatigue tests both in the proximal region of the neck as well as in the distal region of the shaft. Despite these tests, we experienced two clinical fractures of the same product in our clinic. It was shown that these fractures were initiated by a laser engraving of the manufacturer with subsequent crack growth. The basic question raised in the present work was to find out why fracture may not have occurred during experimental preclinical testing. Hence, a supplementary finite element analysis was conducted considering the same hip stem under the prescribed conditions of the test standard in different variations. It was found that the choice of orientation and side (left or right leg) strongly influences stress in the hip stem which has not yet been prescribed in test standards. Depending on the side, only compressive stress may be acting in the experimental situation on the locations under risk, thereby inhibiting clinically relevant crack growth and concealing an actual fracture risk.