Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.79 |
| 2019-02 | 0 | 1.72 |
| 2019-03 | 0 | 1.71 |
| 2019-04 | 0 | 1.79 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 1.84 |
| 2019-07 | 0 | 1.57 |
| 2019-08 | 0 | 2.11 |
| 2019-09 | 0 | 1.64 |
| 2019-10 | 0 | 1.81 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 1.74 |
| 2020-01 | 0 | 1.96 |
| 2020-02 | 0 | 2.08 |
| 2020-03 | 0 | 1.97 |
| 2020-04 | 0 | 1.72 |
| 2020-05 | 0 | 1.63 |
| 2020-06 | 0 | 1.91 |
| 2020-07 | 0 | 2.15 |
| 2020-08 | 0 | 1.79 |
| 2020-09 | 0 | 1.97 |
| 2020-10 | 0 | 2.1 |
| 2020-11 | 0 | 1.85 |
| 2020-12 | 0 | 1.81 |
| 2021-01 | 0 | 2.05 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 2.09 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 1.93 |
| 2021-06 | 0 | 1.78 |
| 2021-07 | 0 | 2.01 |
| 2021-08 | 0 | 2.21 |
| 2021-09 | 0 | 1.9 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 0 | 2.08 |
| 2021-12 | 0 | 2.32 |
| 2022-01 | 0 | 2.52 |
| 2022-02 | 0 | 2.31 |
| 2022-03 | 0 | 2.33 |
| 2022-04 | 0 | 2.34 |
| 2022-05 | 0 | 2.07 |
| 2022-06 | 0 | 2.18 |
| 2022-07 | 0 | 2.19 |
| 2022-08 | 0 | 2.17 |
| 2022-09 | 0 | 1.96 |
| 2022-10 | 0 | 1.98 |
| 2022-11 | 0 | 2.05 |
| 2022-12 | 0 | 1.95 |
| 2023-01 | 0 | 1.81 |
| 2023-02 | 0 | 1.93 |
| 2023-03 | 0 | 2.01 |
| 2023-04 | 0 | 2.16 |
| 2023-05 | 0 | 2.06 |
| 2023-06 | 0 | 2.23 |
| 2023-07 | 0 | 2.02 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 0 | 1.5 |
| 2023-10 | 0 | 1.6 |
| 2023-11 | 1 | 1.63 |
| 2023-12 | 0 | 1.41 |
| 2024-01 | 0 | 1.76 |
| 2024-02 | 0 | 1.78 |
| 2024-03 | 0 | 1.63 |
| 2024-04 | 0 | 1.81 |
| 2024-05 | 0 | 1.62 |
| 2024-06 | 0 | 1.86 |
| 2024-07 | 0 | 1.56 |
| 2024-08 | 0 | 1.68 |
| 2024-09 | 0 | 1.64 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 0 | 1.55 |
| 2024-12 | 0 | 1.57 |
| 2025-01 | 0 | 1.68 |
| 2025-02 | 0 | 1.58 |
| 2025-03 | 0 | 1.85 |
| 2025-04 | 0 | 1.64 |
| 2025-05 | 0 | 1.74 |
| 2025-06 | 0 | 1.86 |
| 2025-07 | 0 | 1.72 |
| 2025-08 | 0 | 1.57 |
| 2025-09 | 0 | 1.47 |
| 2025-10 | 0 | 1.6 |
| 2025-11 | 0 | 1.73 |
| 2025-12 | 0 | 2.16 |
| 2026-01 | 0 | 1.87 |
| 2026-02 | 0 | 1.79 |
| 2026-03 | 0 | 1.7 |
| 2026-04 | 0 | 1.72 |
| 2026-05 | 0 | 1.69 |
| 2026-06 | 0 | 1.73 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-12-07 | Z-0483-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 28 units | clearance family |
| 2021-12-07 | Z-0484-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 432 units | clearance family |
| 2021-12-07 | Z-0485-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 3 units | clearance family |
| 2021-12-07 | Z-0486-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 781 units | clearance family |
| 2021-12-07 | Z-0487-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 3 units | code info di |
| 2021-12-07 | Z-0488-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 870 units | clearance family |
| 2021-12-07 | Z-0489-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 451 units | clearance family |
| 2021-12-07 | Z-0490-2022 | Class II | Terminated | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damageDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. | 140 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-11-28 | 1818910-2023-24137 | Injury | Available | exact di |
Regulatory clearances
- 510(k)K101996Substantially equivalent (SESE) · 2010-12-15clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-07-04 | NAI | No action indicated | DEPUY (IRELAND) | 0 |
| 2015-01-08 | NAI | No action indicated | DEPUY (IRELAND) | 0 |
| 2012-01-26 | VAI | Voluntary action indicated | DEPUY (IRELAND) | 1 |
| 2011-02-03 | NAI | No action indicated | DEPUY (IRELAND) | 0 |
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