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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

 

 

 

 

            

Metal ion levels


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General
522 Number / Requirement Number PS110070 / PSS001
Current Plan Approved 11/01/2012
Study Name Metal ion levels
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 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.
Final Study Results
Interim Safety Information N/A


Metal ion levels Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/02/2013 05/23/2013 Overdue/Received
1 yr report 11/01/2013   Overdue
18 month report 05/02/2014   Overdue
Status Report 1 05/14/2014 05/14/2014 On Time
Status Report 2 05/14/2014 05/14/2014 On Time
2 yr report 11/01/2014   Overdue
3 yr report 11/01/2015    
4 yr report 10/31/2016    


  • 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
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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