title: [Failure analysis as basis for quality assurance strategies in implant technology].
abstract: BACKGROUND
  Implant safety is a topic gaining more and more public interest. Implants are safety relevant medical devices which in the case of failure can lead to life-threatening situations.
  
  
  OBJECTIVE
  A well-founded failure analysis requires expert knowledge not only of materials and implant design but also a qualified explantation procedure and storage conditions.
  
  
  METHODS
  A selective literature search was carried out putting the main emphasis on implant failure analysis supplemented with own investigations.
  
  
  RESULTS
  The reasons for implant breakdown are mostly failures of materials and in the manufacturing process. In some cases false material combinations can lead to tribocorrosion effects under cyclic loading.
  
  
  CONCLUSIONS
  The increased level of knowledge gained from complex analyses of failed implants produces valuable evidence for better quality management.
authors.affiliation: Lehrstuhl Werkstoffe für die Medizintechnik, Universität Rostock, Friedrich-Barnewitz-Str. 4, 18119, Rostock-Warnemünde, Deutschland, detlef.behrend@uni-rostock.de.
authors.forename: D
authors.initials: D
authors.lastname: Behrend
authors.forename: M
authors.initials: M
authors.lastname: Warkentin
authors.forename: D
authors.initials: D
authors.lastname: Klüß
authors.forename: R
authors.initials: R
authors.lastname: Bader
authors.forename: S
authors.initials: S
authors.lastname: Kopp
authors.forename: M
authors.initials: M
authors.lastname: Frank
authors.forename: W
authors.initials: W
authors.lastname: Mittelmeier
mesh_terms: D003627:Data Interpretation, Statistical; D042241:Early Diagnosis; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data*; D005858:Germany / Q000453:epidemiology; D006622:Hip Prosthesis / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D053208:Kaplan-Meier Estimate; D007720:Knee Prosthesis / Q000592:standards / Q000706:statistics & numerical data*; D011159:Population Surveillance / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data*; D016016:Proportional Hazards Models; D011475:Prosthesis Failure; D012042:Registries / Q000592:standards / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013548:Sweden / Q000453:epidemiology