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.
18 linked reportsMalfunction 16Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.74 |
| 2019-02 | 0 | 2.38 |
| 2019-03 | 0 | 2.76 |
| 2019-04 | 0 | 2.66 |
| 2019-05 | 0 | 2.06 |
| 2019-06 | 0 | 1.72 |
| 2019-07 | 0 | 1.74 |
| 2019-08 | 0 | 2.01 |
| 2019-09 | 0 | 2.22 |
| 2019-10 | 0 | 2.41 |
| 2019-11 | 0 | 2.06 |
| 2019-12 | 0 | 2.25 |
| 2020-01 | 0 | 2.54 |
| 2020-02 | 0 | 2.26 |
| 2020-03 | 0 | 2.86 |
| 2020-04 | 0 | 2.07 |
| 2020-05 | 0 | 1.96 |
| 2020-06 | 0 | 1.95 |
| 2020-07 | 0 | 2.28 |
| 2020-08 | 0 | 1.84 |
| 2020-09 | 0 | 2.29 |
| 2020-10 | 0 | 2.18 |
| 2020-11 | 0 | 2.11 |
| 2020-12 | 0 | 2.11 |
| 2021-01 | 0 | 2.29 |
| 2021-02 | 1 | 1.85 |
| 2021-03 | 0 | 1.85 |
| 2021-04 | 1 | 1.93 |
| 2021-05 | 0 | 1.8 |
| 2021-06 | 0 | 2.34 |
| 2021-07 | 0 | 2.05 |
| 2021-08 | 0 | 2.09 |
| 2021-09 | 0 | 2.15 |
| 2021-10 | 0 | 1.99 |
| 2021-11 | 0 | 1.85 |
| 2021-12 | 0 | 2.06 |
| 2022-01 | 0 | 1.87 |
| 2022-02 | 0 | 1.76 |
| 2022-03 | 0 | 1.97 |
| 2022-04 | 0 | 1.95 |
| 2022-05 | 1 | 1.92 |
| 2022-06 | 0 | 2.11 |
| 2022-07 | 0 | 1.88 |
| 2022-08 | 0 | 1.97 |
| 2022-09 | 0 | 2 |
| 2022-10 | 0 | 1.95 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1.91 |
| 2023-01 | 0 | 2.14 |
| 2023-02 | 0 | 1.99 |
| 2023-03 | 0 | 2.21 |
| 2023-04 | 0 | 2.1 |
| 2023-05 | 1 | 2.01 |
| 2023-06 | 0 | 2.07 |
| 2023-07 | 2 | 1.92 |
| 2023-08 | 0 | 1.83 |
| 2023-09 | 1 | 1.87 |
| 2023-10 | 0 | 1.59 |
| 2023-11 | 0 | 1.51 |
| 2023-12 | 0 | 1.61 |
| 2024-01 | 0 | 1.64 |
| 2024-02 | 0 | 1.93 |
| 2024-03 | 0 | 1.87 |
| 2024-04 | 0 | 1.65 |
| 2024-05 | 0 | 1.9 |
| 2024-06 | 1 | 1.8 |
| 2024-07 | 0 | 1.63 |
| 2024-08 | 0 | 1.8 |
| 2024-09 | 0 | 1.93 |
| 2024-10 | 0 | 1.77 |
| 2024-11 | 0 | 1.62 |
| 2024-12 | 0 | 1.5 |
| 2025-01 | 0 | 1.81 |
| 2025-02 | 0 | 1.47 |
| 2025-03 | 0 | 1.81 |
| 2025-04 | 0 | 1.76 |
| 2025-05 | 0 | 1.62 |
| 2025-06 | 0 | 1.78 |
| 2025-07 | 0 | 1.8 |
| 2025-08 | 1 | 1.61 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.64 |
| 2025-11 | 0 | 1.7 |
| 2025-12 | 2 | 1.79 |
| 2026-01 | 1 | 1.85 |
| 2026-02 | 2 | 1.53 |
| 2026-03 | 2 | 1.83 |
| 2026-04 | 0 | 1.77 |
| 2026-05 | 1 | 1.48 |
| 2026-06 | 1 | 1.65 |
Failure-mode summaryAI-generated
17 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-24 | 1818910-2026-10779 | Malfunction | — | exact di |
| 2026-05-28 | 1818910-2026-09332 | Malfunction | Available | exact di |
| 2026-03-13 | 1818910-2026-04794 | Malfunction | Available | exact di |
| 2026-03-11 | 1818910-2026-04624 | Malfunction | Available | exact di |
| 2026-02-26 | 1818910-2026-03790 | Malfunction | Available | exact di |
| 2026-02-13 | 1818910-2026-02976 | Malfunction | Available | exact di |
| 2026-01-20 | 1818910-2026-01163 | Malfunction | Available | exact di |
| 2025-12-30 | 1818910-2025-22704 | Malfunction | Available | exact di |
| 2025-12-15 | 1818910-2025-21862 | Malfunction | Available | exact di |
| 2025-08-18 | 1818910-2025-14345 | Malfunction | Available | exact di |
| 2024-06-03 | 1818910-2024-12137 | Malfunction | Available | exact di |
| 2023-09-28 | 1818910-2023-19664 | Injury | Available | exact di |
| 2023-07-19 | 1818910-2023-14657 | Malfunction | Available | exact di |
| 2023-07-11 | 1818910-2023-13931 | Malfunction | Available | exact di |
| 2023-05-01 | 1818910-2023-09192 | Injury | Available | exact di |
Showing 1–15 of 18
Regulatory clearances
Predicate lineage
Cited as predicate by: K160907, K170339, K202472, K211703, K223745, K233476, K233758, K241472, K241875, K243029, K250375, K251052, K251166, K252401
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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