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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Metal Ion Levels Wright


 
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General
Study Status Revised/Replaced Study
522 Number / Requirement Number PS110070 / PSS001
Date Current Plan Accepted 11/01/2012
Study Name Metal Ion Levels Wright
Root Document Number K004043  K110029  K021349  K031963  K041586  K042530  K041114  K043073  K043099  K082924  K051348  K052915  K053588  K060356  K060358  K061844  K070785  K080663  K081090  K091423  K051995  K041425 
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Metal ions and ALTR assessed in cross-sectional multi-center manner. The primary objective is to compare serum and whole blood cobalt and chromium ion levels in revised and unrevised subjects implanted with components of Wright Medical Technology Metal-on-Metal Total Hip Artoplasty (hip replacement) System out to 8 years post-implant.
Study Population Description Patients who received Wright Medical Technology metal-on-metal hips in the post-market environment.
Sample Size 120 control patients, 380 with THA, 10 clinical sites
Data Collection Serum and whole blood cobalt and chromium level comparison between unrevised and revised subjects. Secondary endpoints include ALTR, radiographic outcomes, Harris Hip Scores
Follow-up Visits and Length of Follow-up Not applicable. This is a cross-sectional study.


Metal Ion Levels Wright Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/02/2013 05/23/2013 Overdue/Received
Status Report 1 05/14/2014 05/14/2014 On Time
Status Report 2 05/14/2014 05/14/2014 On Time


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