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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Natl Joint Registry for England and Wales


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General
Application Number P040023 / PAS005
Current Plan Approved 04/20/2010
Study Name OSB Lead-Natl Joint Registry for England and Wales
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Registry study
Sample Size In data extracted in June 2009, there were approximately 400 hips reportedly implanted with a DURALOC Option Metal Outer Shell in combination with either an AML, Corail, or S-ROM femoral stem.

Data Collection DePuy will provide the following information as the data exists and is permitted by the NJR-EW:

¿ Femoral Stem types

¿ The years in which the surgeries were performed

¿ Patient demographic summaries (age, gender, diagnosis, height, weight, BMI)

¿ Patient listing of reasons for revisions

¿ Revision rate

¿ Death rate

¿ Kaplan-Meier survival estimates

Follow-up Visits and Length of Follow-up The length of follow-up for this study is 10 years. DePuy will request annual data extract reports from the NJR-EW and provide these reports to the FDA in annual progress reports.


OSB Lead-Natl Joint Registry for England and Wales Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/20/2011 04/21/2011 Overdue/Received
2 year report 07/03/2012 06/26/2012 On Time
3 year report 05/17/2013 05/30/2013 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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