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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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Clinical Study

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Study Status Progress Adequate
522 Number / Requirement Number PS110029 / PSS001
Date Current Plan Accepted 12/04/2015
Study Name Clinical Study
Root Document Number K083651  K092331  K063414  K052320  K040354  K070221  K950542  K003250 
General Study Protocol Parameters
Study Design Cross-Sectional 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 This study has a hybrid cross-sectional design based on new enrollment and its main objective is to examine the long term safety and effectiveness of the FMP metal-on-metal (MoM) Acetabular Hip System. The study is aimed to examine devices retrieved after revision and to assess adverse events associated with DJO MoM hip devices. The chromium and cobalt ion levels in whole blood and serum samples from implanted subjects will be prospectively determined at different post-implant time points. Secondary objectives of the study include: (1) evaluation of the overall success of the device over time, (2) the effect of nutritional status on metal ion concentrations and 3) the effect of demographic factors on device outcomes. The primary null hypothesis is that there will be no change in chromium or cobalt ion concentrations at a specified post-implant time point compared to baseline. The hypothesis will be tested for the metal ion concentrations in both whole blood (erythrocytes) and serum at multiple time points. However, multiple comparison corrections will not be used for two metal ion types, repeated tests (Year 1, 2, etc.), or for two sample types (blood or serum). Sample size calculations and subsequent statistical tests will use a 5% type 1 error rate for two-sided tests.

Study Population Description The main study population will consist of consented subjects (>18 year-old) who are scheduled for hip replacement surgery; the study population will include baseline (pre-implantation) subjects with similar indications as a candidate for MoM hip replacement. General exclusion criteria are metal allergies and renal dysfunction.

Sample Size With a total proposed sample size of 340 subjects (one visit per subject), the two cohorts will be as follows: Cohort B (N=315): Subjects who qualify for the study, including subjects who have not been implanted with any hip implant and are seen only at baseline (N = 75) and subjects who have a DJO MoM implant, have not had a revision, and are seen at a single cross-sectional post-op time point between Year 1 and Year 8 (N = 240, i.e., 30 at each time point). Cohort C, sample size 25: Subjects who have received a DJO MoM implant that will be revised in the near future. These subjects will provide data at one time point, the time of revision.

Data Collection The chromium and cobalt ion concentrations will be determined in all subjects in both Cohorts B and C. Serum cobalt concentration [Co-S], serum chromium concentration [Cr-S] and blood chromium concentration [Cr-B] will be measured using inductively coupled mass spectroscopy. Metal ion measurements will be examined with regards to time after surgery, adverse local tissue reactions, revision rates and physical exam findings.

Follow-up Visits and Length of Follow-up Not applicable; All patients will be assessed in a single visit (i.e., a total of 340 subject-visits with no plans to assess the same patient at more than one time point).

Clinical Study Schedule

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


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