Mobile-bearing knee systems: ultra-high molecular weight polyethylene wear and design issues.
In June 2004, the U.S. Food and Drug Administration Orthopaedic Advisory Panel recommended the reclassification of mobile-bearing knee systems for general use. This reflects the increasing use of mobile-bearing knee systems internationally, which is currently limited in the United States by regulatory requirement. Mobile-bearing knee systems are distinguished from conventional, fixed-plateau systems in that they allow dual-surface articulation between an ultra-high molecular weight polyethylene insert and metallic femoral and tibial tray components. Their in vivo success is dependent on patient selection, design, and material choice, as well as surgical precision during implantation. Laboratory and clinical experience extending over 25 years with individual systems suggests that mobile-bearing knee systems represent a viable treatment option for patients with knee arthrosis.
Greenwald
A Seth
AS
Orthopaedic Research Laboratories, Lutheran Hospital, Cleveland Clinic Health System, Ohio, USA.
Heim
Christine S
CS
D019645:Arthroplasty, Replacement, Knee; D001696:Biomechanical Phenomena; D003257:Consumer Product Safety; D018795:Device Approval; D019544:Equipment Failure Analysis; D006801:Humans; D007720:Knee Prosthesis / Q000592:standards / Q000706:statistics & numerical data; D011095:Polyethylenes; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration
D011095:Polyethylenes; C111601:ultra-high molecular weight polyethylene