PMA · Approved
Recalled · Class II · 2013Trilogy AB Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Approved on Jun 28, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 561-day review. It has been recalled 4 times.
- Decided
- Jun 28, 2006
- Review
- 561 days
- Class
- Class III
- Product code
- MRA
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040048 has 14 supplements since 2006: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-1028-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| Sep 14, 2012 | Class II | Z-0774-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| Sep 14, 2012 | Class II | Z-0776-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| May 29, 2009 | Not classified | Z-1616-2009 | Packaging process control | The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MRA devicesMRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRA
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRA
Too few MRA 510(k)s in any year since 2007 to give a median.
Recalls per year · MRA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRA
88in 2025
MAUDE reports naming product code MRA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | — | 0 | 117 |
| 2008 | 12 | — | 5 | 146 |
| 2009 | 14 | — | 1 | 91 |
| 2010 | 14 | — | 0 | 188 |
| 2011 | 12 | — | 6 | 248 |
| 2012 | 28 | — | 2 | 283 |
| 2013 | 17 | — | 1 | 235 |
| 2014 | 9 | — | 0 | 281 |
| 2015 | 18 | — | 0 | 330 |
| 2016 | 26 | — | 0 | 367 |
| 2017 | 16 | — | 0 | 540 |
| 2018 | 11 | — | 0 | 696 |
| 2019 | 17 | — | 0 | 641 |
| 2020 | 13 | — | 0 | 371 |
| 2021 | 18 | — | 0 | 109 |
| 2022 | 33 | — | 0 | 89 |
| 2023 | 19 | — | 0 | 132 |
| 2024 | 16 | — | 0 | 118 |
| 2025 | 18 | — | 0 | 88 |
| 2026 | 7 | — | 0 | — |
https://510kreport.com/device/P040048 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040048: Trilogy AB Acetabular System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040048
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026