|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS110029 / PSS002 |
| Date Original Plan Accepted |
10/15/2012
|
| Date Current Plan Accepted |
03/05/2015
|
| Study Name |
Device Retrieval Study
|
| Device Name |
Encore clp offset total hip system, metal/metal hip system,fmp metal/metal acetabular insert, revelation stem,djo surgical revision femoral i-lip system, metal backed acetabular component,
|
| Root Document Number |
K052320
K083651
K092331
K063414
K040354
K070221
K950542
K003250
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| 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 Objectives |
Explant Analysis / Failed devices will be retrieved
|
| Study Population |
Explanted devices from patients who had hip replacement surgery with the study device.
|
| Sample Size |
25 retrievals; 26 sites
|
| Key Study Endpoints |
Explant analysis per guidelines (ASTM F561-05a)
|
| Follow-up Visits and Length of Follow-up |
Not applicable. This is an analysis of explanted devices.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
7 revisions were included in the study cohort; 6 out of the 7 explants provided analytical data. The sponsor has complemented the 6 revision cases with 15 explants via the complaint handling process; this provides for a total of 21 explants available foranalysis. However, only limited clinical information is available on these additional 15 explants.
|
| Actual Number of Sites Enrolled |
8 sites
|
| Patient Followup Rate |
N/A
|
| Final Safety Findings |
Due to limited numbers of explanted components and tissues collected and analyzed, no conclusive modes and causes of failure could be made.
|
| Final Effectiveness Findings |
The study is intended to provide safety information only.
|
| Study Strengths and Weaknesses |
The study provides detailed explant analysis for 6 explants in the revision cohort of the 522 study. However, the sample size is too small to identify any modes and causes of failure. Additional explants (outside the study) were provided to supplement the limited number of study explants, though lacking clinical data.
|
| Recommendations for Labeling Changes |
No labeling update is recommended. The device is no longer available on US market.
|
