An analysis of Food and Drug Administration medical device reports relating to total joint components

Castro, F. P., Chimento, G., Munn, B. G., Levy, R. S., Timon, S. and Barrack, R. L. (1997). An analysis of Food and Drug Administration medical device reports relating to total joint components. In: Annual Meeting of the American Association of Hip and Knee Surgeons, Dallas, TX United States, (765-771). November 1996. doi:10.1016/S0883-5403(97)90006-1


Author Castro, F. P.
Chimento, G.
Munn, B. G.
Levy, R. S.
Timon, S.
Barrack, R. L.
Title of paper An analysis of Food and Drug Administration medical device reports relating to total joint components
Conference name Annual Meeting of the American Association of Hip and Knee Surgeons
Conference location Dallas, TX United States
Conference dates November 1996
Journal name Journal of Arthroplasty   Check publisher's open access policy
Place of Publication Philadelphia, PA, United States
Publisher Churchill Livingstone
Publication Year 1997
Sub-type Fully published paper
DOI 10.1016/S0883-5403(97)90006-1
ISSN 0883-5403
1532-8406
Volume 12
Issue 7
Start page 765
End page 771
Total pages 6
Language eng
Abstract/Summary 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.
Keyword arthroplasty
complications
modularity
polyethylene wear
HIP
Q-Index Code E1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Conference Paper
Collection: School of Medicine Publications
 
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Created: Mon, 14 Mar 2011, 08:50:21 EST