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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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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.

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Explant


 
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General
Study Status Progress Inadequate
522 Number / Requirement Number PS110070 / PSS003
Date Current Plan Accepted 07/23/2021
Study Name Explant
Root Document Number K004043  K021349  K031963  K041425  K042530  K043073  K043099  K041586  K041114  K061844  K060358  K060356  K053588  K052915  K051995  K051348  K070785  K080663  K082924  K110029  K081090  K091423 
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The main study objective is to conduct an analysis of revised and retrieved cases of MOM THA involved in the Post-Market Surveillance study in order to correctly identify all failure modes. The study design is explant analysis.

Study Population Description The study population is comprised of patients who have had a revised metal-on-metal hip.
Sample Size There is not a control group.
Data Collection The data collection for the study is new data collection
Follow-up Visits and Length of Follow-up n/a


Explant Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/19/2017 09/08/2017 On Time
1 year report 03/21/2018 03/13/2018 On Time
2 year report 03/21/2019 03/28/2019 Overdue/Received
3 year report 03/20/2020 03/17/2020 On Time
4 year report 03/21/2021 03/17/2021 On Time
final report 03/22/2022    


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