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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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SUI AE and Effectiveness rates

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522 Number / Requirement Number PS120093 / PSS001
Current Plan Approved 08/29/2016
Study Name SUI AE and Effectiveness rates
Root Document Number K081275 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is multi-center, cross-sectional. There is not a study hypothesis.

Study Population Description The study population is comprised of 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

For baseline measurement of pre-implant whole blood and serum cobalt and chromium ion levels 120 males and females who do not currently have a medical device implant and meet the inclusion/exclusion criteria will be enrolled.

Sample Size

The study population is expected to be comprised of 400 males and females who underwent metal on metal THR within the last 96 months (range 1-8 years) and meet the inclusion/exclusion criteria. Subjects will be enrolled at up to 15 clinical sites.

For baseline values of non-implantable subjects that will be used as a reference with the cross-sectional study subjects’ whole blood and serum cobalt and chromium ion levels. At the cross-sectional study sites, any non-implanted patient who is a candidate to undergo MoM THR with a Zimmer hip system will be asked to enroll in the study. A total of 120 cases are expected to be included in this study group.

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 Patients will undergo a one-time cross-sectional assessment, as available by product release date (3 months - 8 years post-op).

SUI AE and Effectiveness rates Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/01/2013 08/01/2013 On Time
1 yr report 01/31/2014 01/31/2014 On Time
18 month report 08/01/2014 07/31/2014 On Time
2 yr report 01/31/2015 02/02/2015 Overdue/Received
3 yr report 01/31/2016 01/29/2016 On Time
4 yr report 01/30/2017    
Final report 06/29/2018    

  • 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.


Contact Information

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

Phone: (301) 796-6068
Fax: (301) 847-8140