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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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Time to Revision


 
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General
Study Status Completed
522 Number / Requirement Number PS110004 / PSS001
Date Current Plan Accepted 01/13/2017
Study Name Time to Revision
Root Document Number P020016 
General Study Protocol Parameters
Study Design Prospective & Retrospective 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 study design includes the following two groups/arms: 1. A prospective, observational study through 2015 to collect follow-up data on all subjects who received a Biomet TMJ Replacement System between 1995 - 2010 and for who Biomet holds current contact information. 2. A retrospective review to collect data on demographics, clinical history and diagnosis for subjects treated with the Biomet TMJ Replacement System between 2005 - 2010
Study Population Description 18 to 21 yrs; Adult 21+
Sample Size 329 patients
Data Collection Primary endpoint: The revision rate of the implant for patients who received the Biomet TMJ Replacement Device between 1995 and 2010 and who participate in the prospective observational study.
Follow-up Visits and Length of Follow-up FU Visits: Annually; Length of FU: from 2 to 20 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 498
Actual Number of Sites Enrolled 1
Patient Followup Rate 100%
Final Safety Findings Reasons for first SSIs included fibrous ankylosis (21.4%), heterotopic bone formation (17.9%), infection (14.3%), and pain/swelling (12.5%).
Final Effectiveness Findings The rate of first subsequent surgical interventions (SSIs) was 11.2% (56/498), the rate of reoperations was 7.0% (35/498) and the rate of implant removals was 4.2% (21/498).
The probability of survival was 96% at 3 years, 94% at 5 years and 86% at 10 years post- operative.
Study Strengths and Weaknesses Strengths: Large sample size, long follow-up period, high follow-up rate. Weaknesses:Follow up was done by mailing questionnaires. No physical examination was conducted.
Recommendations for Labeling Changes Label to be updated with the time to revision results


Time to Revision Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 Month Report 10/24/2012 10/24/2012 On Time
1 year report 04/24/2013 04/25/2013 Overdue/Received
18 month report 10/23/2013 10/18/2013 On Time
2 year report 04/24/2014 04/23/2014 On Time
3 year report 04/24/2015 04/23/2015 On Time
Final Report 03/30/2016 03/29/2016 On Time


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