1. An analysis of Food and Drug Administration medical device reports relating to total joint components.
- Author
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Castro FP Jr, Chimento G, Munn BG, Levy RS, Timon S, and Barrack RL
- Subjects
- Evaluation Studies as Topic, Humans, Prosthesis Failure, United States, United States Food and Drug Administration, Hip Prosthesis, Knee Prosthesis, Product Surveillance, Postmarketing
- 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.
- Published
- 1997
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