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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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Device Retrieval Study


 
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General
Study Status Completed
522 Number / Requirement Number PS110029 / PSS002
Date Original Plan Accepted 10/15/2012
Date Current Plan Accepted 03/05/2015
Study Name Device Retrieval Study
Device Name Encore clp offset total hip system, metal/metal hip system,fmp metal/metal acetabular insert, revelation stem,djo surgical revision femoral i-lip system, metal backed acetabular component,
Root Document Number K052320  K083651  K092331  K063414  K040354  K070221  K950542  K003250 
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Explant Analysis / Failed devices will be retrieved
Study Population Explanted devices from patients who had hip replacement surgery with the study device.
Sample Size 25 retrievals; 26 sites
Key Study Endpoints Explant analysis per guidelines (ASTM F561-05a)
Follow-up Visits and Length of Follow-up Not applicable. This is an analysis of explanted devices.
Interim or Final Data Summary
Actual Number of Patients Enrolled 7 revisions were included in the study cohort; 6 out of the 7 explants provided analytical data. The sponsor has complemented the 6 revision cases with 15 explants via the complaint handling process; this provides for a total of 21 explants available foranalysis. However, only limited clinical information is available on these additional 15 explants.
Actual Number of Sites Enrolled 8 sites
Patient Followup Rate N/A
Final Safety Findings Due to limited numbers of explanted components and tissues collected and analyzed, no conclusive modes and causes of failure could be made.
Final Effectiveness Findings The study is intended to provide safety information only.
Study Strengths and Weaknesses The study provides detailed explant analysis for 6 explants in the revision cohort of the 522 study. However, the sample size is too small to identify any modes and causes of failure. Additional explants (outside the study) were provided to supplement the limited number of study explants, though lacking clinical data.
Recommendations for Labeling Changes No labeling update is recommended. The device is no longer available on US market.


Device Retrieval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/15/2013 04/17/2013 Overdue/Received
one year report 11/15/2013 03/21/2014 Overdue/Received
18 month report 04/18/2014 04/18/2014 On Time
2 year report 11/24/2014 11/24/2014 On Time
3 yr report 09/03/2015 09/16/2015 Overdue/Received
4 year report 10/07/2016 10/11/2016 Overdue/Received
5 year report 09/06/2017 09/06/2017 On Time
Final Report 09/06/2018 09/19/2018 Overdue/Received


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources
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