|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS110005 / PSS002 |
| Date Original Plan Accepted |
11/15/2012
|
| Date Current Plan Accepted |
06/14/2013
|
| Study Name |
Explant Analysis
|
| Device Name |
Porous titanium acetabular augments, m2a magnum 12/14 taper inserts and one-piece modular heads
|
| Root Document Number |
K052888
K061423
K062994
K062995
K063002
K063514
K070274
K073637
K062998
K993438
K002379
K011110
K042037
K042774
K042841
K050124
K043547
K082446
K090757
K050251
K050441
K093235
K852351
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| 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 have received one of two Biomet implant types; a MOP primary THA or Biomet MOM primary THA devices (M2a Ringloc, M2a Taper, M2a 38 or the M2a Magnum).
|
| Sample Size |
At least 80 - 100 retrievals
|
| Key Study Endpoints |
Endpoints are based on the analysis of retrieved components (Stages 1-3) in conjunction with available clinical information (see data collection field for PS110005/PSS001-Metal Ions Levels Study).
|
| 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 |
Actual number of retrievals enrolled:
Stage 1 analysis – 181 retrievals; Stage 2 analysis – 69 retrievals
|
| Actual Number of Sites Enrolled |
4 sites
|
| Patient Followup Rate |
N/A
|
| Final Safety Findings |
According to this 522 Explant Analysis study results, device safety for the following Biomet Metal-on-Metal Hip Arthroplasty devices: M2a 38mm, M2a Magnum, M2a Ringloc, and M2a Taper, is consistent with the expected safety of MoM hip arthroplasty devices in general. No unexpected adverse events were identified in association with the devices under review.
However, a relationship between the incidence of pseudotumors and taper wear was identified, indicating potential safety issues associated with the Titanium taper used in Biomet MoM THA. The Biomet explant analysis also showed a relatively high incidence rate of edge-loaded cups leading to higher metal wear rates. On the other hand, severe tissue reactions were noted in association with what would appear a small amount of wear, indicating possible variability in individual patient responses.
|
| Final Effectiveness Findings |
According to this 522 study results, device performance for the following Biomet Metal-on- Metal Hip Arthroplasty devices: M2a 38mm, M2a Magnum, M2a Ringloc, and M2a Taper, is consistent with that of MoM hip arthroplasty devices in general.
|
| Study Strengths and Weaknesses |
Additional information on the role of taper interface that was derived from this study can help with optimizing management of patients with MoM THA arthroplasty.. Nonetheless, the current study raises the need for development of updated criteria for MoM THA related metal particle analysis and metal ion blood/serum measurements (including but not limited to Co and Cr).
|
| Recommendations for Labeling Changes |
: No labeling change is being recommended because Biomet MoM THA devices are no longer marketed.
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