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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

 

 

 

 

            

Cross-Sectional Study


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General
522 Number / Requirement Number PS110093 / PSS001
Current Plan Approved 06/28/2013
Study Name Cross-Sectional Study
Root Document Number K871453  K032348  K033634  K033943  K974728  K003758  K053536  K071723  K091003  K091973  K063251  K071856  K073499  K081007 
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. This is a cross-sectional, multi-center study of several Zimmer metal-on-metal (MoM) hip implant systems. The study subjects will be grouped in three cohorts: 1. cross-section of subjects with a Zimmer total hip arthoplasty (THA). They will be assessed for ALTR and subjecst suspected or confirmed with ALTR will be follwed for up to one year following the baseline assesment or until revision is necessary (which ever occurs first). 2. Subjects in second cohort do not yet have an implant but are candidates for a MoM total hip system. 3. Subjects in the 3rd cohort have MoM hips and are in need or revision.

Study Population Description "The study population is expected to be comprised of 400 males and females who underwent metal on metal THR within the last 96 months. Patients implanted with any of the following devices:

Zweymuller-SL Hip Prosthesis Stem, Metasul Taper Liners, Metasul Femoral Heads, Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology, Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model(s) 7848 Series (modular necks) 7713 Series, and Zimmer M/L Taper Hip Prosthesis."

Sample Size 120 patients without device implants, 400 patients who underwent metal-on-metal THA., 15 sites
Data Collection Study endpoints include adverse events, changes in metal ion concentrations in whole blood and serum over time, radiographic results and any incidence of adverse local tissue reactions that might be linked to metal ion levels or certain patient clinical or demographic characteristics.
Follow-up Visits and Length of Follow-up This is a cross-sectional study. However, subjecst suspected or confirmed with ALTR will be follwed for up to one year following the baseline assesment or until revision is necessary (which ever occurs first).

Final Study Results
Interim Safety Information N/A


Cross-Sectional Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/06/2013 05/15/2013 On Time
1 yr report 12/06/2013 11/25/2013 On Time
18 month report 06/06/2014 06/06/2014 On Time
2 yr report 12/06/2014 12/11/2014 Overdue/Received
3 yr report 12/06/2015    
39 month report 06/05/2016    
Final Report 07/06/2016    


  • 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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