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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Explant Analysis


 
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General
Study Status Completed
522 Number / Requirement Number PS110005 / PSS002
Date Current Plan Accepted 06/14/2013
Study Name Explant Analysis
Root Document Number K052888  K061423  K062994  K062995  K063002  K063514  K070274  K073637  K062998  K993438  K002379  K011110  K042037  K042774  K042841  K050124  K043547  K082446  K090757  K050251  K050441  K093235  K852351 
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Explant Analysis / Failed devices will be retrieved

Study Population Description Explanted devices from patients who have received one of two Biomet implant types; a MOP primary THA or Biomet MOM primary THA devices (M2a Ringloc, M2a Taper, M2a 38 or the M2a Magnum).

Sample Size At least 80 - 100 retrievals

Data Collection Endpoints are based on the analysis of retrieved components (Stages 1-3) in conjunction with available clinical information (see data collection field for PS110005/PSS001-Metal Ions Levels Study).

Follow-up Visits and Length of Follow-up Not applicable. This is an analysis of explanted devices.



Explant Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 yr report 02/12/2014 02/19/2014 Overdue/Received
3 yr report 02/12/2015 02/13/2015 Overdue/Received
Final Report 11/29/2015 12/01/2015 Overdue/Received


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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