title: An analysis of Food and Drug Administration medical device reports relating to total joint components.
abstract: A total of 1,717 total hip and 2,769 total knee medical device reports submitted to the U.S. Food and Drug Administration (FDA) from 1984 through 1993 were reviewed. A large percentage of total hip complications could be attributed to some aspect of component modularity. Cementless modular acetabular components were the single largest source of device-related complications. Fifty-six percent of total knee medical device reports (MDRs) were associated with accelerated polyethylene wear. By location, MDRs identified patellar (46%), tibial (33%), and femoral (5%) component complications. It was estimated that less than 5% of device-related complications were reported to the FDA. Based on the reports received, it was apparent that mechanical failure of components was a common and increasing cause of total joint revision.
authors.affiliation: Department of Orthopaedic Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USA.
authors.forename: F P
authors.initials: FP
authors.lastname: Castro
authors.forename: G
authors.initials: G
authors.lastname: Chimento
authors.forename: B G
authors.initials: BG
authors.lastname: Munn
authors.forename: R S
authors.initials: RS
authors.lastname: Levy
authors.forename: S
authors.initials: S
authors.lastname: Timon
authors.forename: R L
authors.initials: RL
authors.lastname: Barrack
mesh_terms: D005069:Evaluation Studies as Topic; D006622:Hip Prosthesis; D006801:Humans; D007720:Knee Prosthesis; D011358:Product Surveillance, Postmarketing; D011475:Prosthesis Failure; D014481:United States; D014486:United States Food and Drug Administration