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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 Completed
522 Number / Requirement Number PS110004 / PSS002
Date Current Plan Accepted 11/25/2013
Study Name Explant
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 "This is a study of retrieved explants based on the number of revision cases for which explants are retrieved. This study will evaluate explants retrieved through:

1. a prospective, multi-center trial that enrolls subjects who previously received a Biomet TMJ Replacement System (Study A, PS110004) and who are undergoing a revision procedure;

2. an analysis of explants returned to Biomet through the complaint handling process

3. explants received from all revisions which occur during the survival study (PS110004A) at sites enrolled in the survival study, whether or not revisions came from the survival analysis.

"

Study Population Description 18 to 21 yrs; Adult 21+

Sample Size 20 explanted joints

Data Collection The study endpoints will include analysis of the modes and causes of failure. The potential effect of a subject¿s demographic data, clinical history, or diagnosis on device failure will also be performed.

Follow-up Visits and Length of Follow-up Not applicable

Interim or Final Data Summary
Actual Number of Patients Enrolled 40 explanted joints

Actual Number of Sites Enrolled 8

Patient Followup Rate 100%
Final Safety Findings The majority of the enrolled joints (65%, 26/40) had a Biologic Cause of Failure, indicating these joints were removed for biologic reasons such as re-ankylosis and infection.

Only 12.5% of explants (5/40) were determined to have a Probable Mode of Failure. The most probable reasons leading to mechanical failure of these devices were related to improper surgical technique (n=4) or trauma resulting in a failure of the device secondary to the impact (n=1). There were no evidence or trends found that suggested a failure of the implant materials when used appropriately and when subject to typical loads over a period of time.

The most common Biologic Cause of Failure was: bone formation with ankylosis which was consistent with the preoperative diagnosis in these patients.

The majority of the enrolled joints (72.5%, 29/40) had no Mode of Failure, indicating there was no mechanical issue with the Biomet TMJ Replacement Device that led to its explanation.

Final Effectiveness Findings The mean time to revision for these cases was 5.0 ± 4.4 years.

Preoperative diagnoses that were found to lead to a shorter time to revision included arthritis and ankylosis. In both diagnoses, the mean time to revision was more than 13 years. These results are consistent with those reported in PS110004A-Time to revision.

Study Strengths and Weaknesses Strengths: Large sample size, long follow-up period, high follow-up rate. Weaknesses: Limited information available, such as oxidation measurements, radiographs and pathology.
Recommendations for Labeling Changes Label to be updated with the explant analysis results


Explant 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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