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Updated: Aug 1, 2026
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Published on: September 4, 2016
An analysis of Food and Drug Administration medical device reports relating to total joint components
F P Castro1, G Chimento, B G Munn
1Department of Orthopaedic Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USA.
Insights
Medical device reports reveal that component modularity caused many hip complications, while polyethylene wear led to knee issues. Mechanical failures are a growing cause of total joint revision surgery.
Area of Science:
- Orthopedic Surgery
- Biomedical Engineering
- Medical Device Regulation
Background:
- Total hip and knee arthroplasty are common procedures for joint degeneration.
- Medical device reporting systems are crucial for post-market surveillance of orthopedic implants.
Purpose of the Study:
- To analyze medical device reports (MDRs) for total hip and knee arthroplasty from 1984-1993.
- To identify common causes of device-related complications and total joint revision.
Main Methods:
- Reviewed 1,717 total hip and 2,769 total knee MDRs submitted to the U.S. Food and Drug Administration (FDA).
- Categorized complications by device type, component location, and suspected cause.
Main Results:
- Component modularity was a major source of total hip complications, particularly cementless acetabular components.
- Accelerated polyethylene wear was associated with 56% of total knee MDRs, with patellar components most affected.
- Mechanical failure was identified as a common and increasing cause of total joint revision.
Conclusions:
- Modularity in hip implants and polyethylene wear in knee implants are significant concerns.
- Underreporting of device-related complications to the FDA is substantial, likely less than 5%.
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.
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