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.
13 linked reportsInjury 10Malfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.77 |
| 2019-02 | 0 | 1.78 |
| 2019-03 | 0 | 1.42 |
| 2019-04 | 0 | 1.51 |
| 2019-05 | 2 | 1.62 |
| 2019-06 | 0 | 1.9 |
| 2019-07 | 1 | 1.54 |
| 2019-08 | 1 | 1.46 |
| 2019-09 | 0 | 1.37 |
| 2019-10 | 0 | 1.54 |
| 2019-11 | 1 | 1.32 |
| 2019-12 | 0 | 2.25 |
| 2020-01 | 0 | 1.56 |
| 2020-02 | 0 | 1.8 |
| 2020-03 | 1 | 2.5 |
| 2020-04 | 0 | 1.85 |
| 2020-05 | 0 | 1.44 |
| 2020-06 | 0 | 3.45 |
| 2020-07 | 0 | 4.3 |
| 2020-08 | 0 | 4.04 |
| 2020-09 | 0 | 3.65 |
| 2020-10 | 0 | 4.49 |
| 2020-11 | 0 | 4.62 |
| 2020-12 | 0 | 6.89 |
| 2021-01 | 0 | 4.59 |
| 2021-02 | 0 | 5.04 |
| 2021-03 | 0 | 2.55 |
| 2021-04 | 1 | 2.34 |
| 2021-05 | 0 | 4.35 |
| 2021-06 | 0 | 4.25 |
| 2021-07 | 0 | 3.72 |
| 2021-08 | 0 | 4.1 |
| 2021-09 | 0 | 5.22 |
| 2021-10 | 0 | 3.36 |
| 2021-11 | 0 | 3.65 |
| 2021-12 | 0 | 3.7 |
| 2022-01 | 0 | 3.45 |
| 2022-02 | 0 | 4.9 |
| 2022-03 | 0 | 4.12 |
| 2022-04 | 0 | 4.15 |
| 2022-05 | 0 | 6.31 |
| 2022-06 | 0 | 3.39 |
| 2022-07 | 0 | 4.53 |
| 2022-08 | 0 | 3.43 |
| 2022-09 | 1 | 2.92 |
| 2022-10 | 0 | 3.98 |
| 2022-11 | 0 | 3.28 |
| 2022-12 | 0 | 4 |
| 2023-01 | 0 | 4.36 |
| 2023-02 | 0 | 3.3 |
| 2023-03 | 0 | 2.46 |
| 2023-04 | 0 | 4.15 |
| 2023-05 | 0 | 3.16 |
| 2023-06 | 0 | 3.73 |
| 2023-07 | 0 | 2.36 |
| 2023-08 | 1 | 2.22 |
| 2023-09 | 0 | 1.91 |
| 2023-10 | 0 | 2.17 |
| 2023-11 | 0 | 2.82 |
| 2023-12 | 0 | 2.07 |
| 2024-01 | 0 | 2.93 |
| 2024-02 | 0 | 2.34 |
| 2024-03 | 0 | 2.52 |
| 2024-04 | 0 | 2.88 |
| 2024-05 | 0 | 1.89 |
| 2024-06 | 1 | 2.34 |
| 2024-07 | 0 | 2.96 |
| 2024-08 | 0 | 2.73 |
| 2024-09 | 0 | 2.57 |
| 2024-10 | 0 | 2.26 |
| 2024-11 | 0 | 2.1 |
| 2024-12 | 0 | 2.91 |
| 2025-01 | 1 | 2.17 |
| 2025-02 | 0 | 2.1 |
| 2025-03 | 0 | 2.12 |
| 2025-04 | 1 | 2.27 |
| 2025-05 | 0 | 2.21 |
| 2025-06 | 0 | 1.89 |
| 2025-07 | 0 | 2.48 |
| 2025-08 | 0 | 1.79 |
| 2025-09 | 0 | 2.36 |
| 2025-10 | 0 | 2.55 |
| 2025-11 | 1 | 1.91 |
| 2025-12 | 0 | 2.54 |
| 2026-01 | 0 | 1.67 |
| 2026-02 | 0 | 2.14 |
| 2026-03 | 0 | 2.26 |
| 2026-04 | 0 | 1.97 |
| 2026-05 | 0 | 2.54 |
| 2026-06 | 0 | 1.97 |
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-11-14 | 1818910-2025-19908 | Injury | Available | exact di |
| 2025-04-21 | 1818910-2025-06055 | Injury | Available | exact di |
| 2025-01-22 | 1818910-2025-01262 | Malfunction | Available | exact di |
| 2024-06-27 | 1818910-2024-14164 | Injury | Available | exact di |
| 2023-08-25 | 1818910-2023-17584 | Injury | Available | exact di |
| 2022-09-13 | 1818910-2022-17795 | Injury | Available | exact di |
| 2021-04-15 | 1818910-2021-08077 | Injury | Available | exact di |
| 2020-03-30 | 1818910-2020-09636 | Malfunction | Available | exact di |
| 2019-11-27 | 1818910-2019-118444 | Injury | Available | exact di |
| 2019-08-30 | 1818910-2019-102691 | Injury | Available | exact di |
| 2019-07-10 | 1818910-2019-97907 | Malfunction | Available | exact di |
| 2019-05-29 | 1818910-2019-94669 | Injury | Available | exact di |
| 2019-05-29 | 1818910-2019-94670 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
Cited as predicate by: K241000, K242665, K252887, K253197, K261458
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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