• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

  • Print
  • Share
  • E-mail
-
The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

Learn more...

            

Metal Ion Levels Microport


 
Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Inadequate
522 Number / Requirement Number PS110070 / PSS002
Date Current Plan Accepted 03/09/2021
Study Name Metal Ion Levels Microport
Root Document Number K004043  K021349  K031963  K041425  K042530  K043073  K043099  K041586  K041114  K051348  K051995  K052915  K053588  K060356  K060358  K061844  K070785  K080663  K082924  K091423  K081090  K110029 
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is multi-center, cross-sectional, new enrollment. The primary objective of the study is to determine the prevalence of adverse local issue reactions (ALTR) in subjects implanted with the WMT MoM THA System overall and for each defined cross-section interval. Secondary objectives include the determination of whole blood and serum cobalt and chromium metal levels for subjects implanted with the WMT MoM THA System overall and for each defined cross-sectional interval and the estimation of baseline whole blood and serum cobalt and chromium ion levels in subjects not implanted with any metal implant.

Study Population Description The study population is comprised of patients who received WMT metal-on-metal hip implants. The control group is comprised of patients without metallic implants, with the exception of dental implants.

Sample Size The sample size for Group 1 is 155 subjects who must have been implanted between 4 and 8 years prior to the study start date. The sample size for Group 2, the control group, is 100 patients.

Data Collection Study endpoints include Adverse Local Tissue Reaction (ALTR), serum and whole blood cobalt and chromium metal ions, and HOOS (Hip disability and Osteoarthritis Outcome Score, ) and the comparison of functional outcomes in subjects with and without confirmed ALTR.

Follow-up Visits and Length of Follow-up Attempts will be made to enroll all eligible patients at participating clinical sites. Patients who present with ALTR will be followed for 1 year

or until revision, whichever occurs first.



Interim or Final Data Summary
Interim Safety Information The sponsor is collecting metal ion levels in serum and whole blood and functional outcomes (HOOS score) in subjects with and without metal-on-metal total hip systems. The sponsor is collecting MRI data on subjects with metal-on-metal total hip systems to assess adverse local tissue reaction (ALTR). Ion levels in patients with MoM implants are higher than those of patients without MoM implants. The study is ongoing at this time and no other conclusions can be drawn from the interim data.
Actual Number of Patients Enrolled A total of 162 patients (173 hips) have been enrolled.
Actual Number of Sites Enrolled A total of 4 sites have been enrolled.
Patient Followup Rate Not applicable, not a longitudinal follow-up study. (Only patients with ALTR diagnosis are to be followed for 1 year or until revision.)
Study Strengths and Weaknesses This information will be included in the final report.


Metal Ion Levels Microport Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 07/31/2017 10/25/2017 On Time
1 year report 01/30/2018 01/25/2018 On Time
18 month report 07/31/2018 07/27/2018 On Time
2 year report 01/30/2019 01/25/2019 On Time
30 month report 07/31/2019 07/31/2019 On Time
36 month report 01/30/2020 01/30/2020 On Time
42 month report 07/30/2020 07/30/2020 On Time
4 year report 01/29/2021 01/27/2021 On Time
54 month report 07/29/2021 07/14/2021 On Time
5 year report 01/29/2022    
final report 03/22/2022    


-
-