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.
52 linked reportsInjury 30Malfunction 19Death 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.71 |
| 2019-02 | 1 | 5.36 |
| 2019-03 | 1 | 3.38 |
| 2019-04 | 0 | 5.83 |
| 2019-05 | 0 | 3.67 |
| 2019-06 | 2 | 6.08 |
| 2019-07 | 4 | 6.23 |
| 2019-08 | 1 | 13.93 |
| 2019-09 | 0 | 14.91 |
| 2019-10 | 3 | 23.47 |
| 2019-11 | 3 | 34.33 |
| 2019-12 | 0 | 24.64 |
| 2020-01 | 0 | 19.47 |
| 2020-02 | 1 | 10.83 |
| 2020-03 | 0 | 9.93 |
| 2020-04 | 0 | 6.62 |
| 2020-05 | 0 | 5.7 |
| 2020-06 | 0 | 9.11 |
| 2020-07 | 3 | 5.53 |
| 2020-08 | 1 | 4.22 |
| 2020-09 | 6 | 6.07 |
| 2020-10 | 3 | 3.82 |
| 2020-11 | 1 | 18.75 |
| 2020-12 | 0 | 6.3 |
| 2021-01 | 0 | 5.33 |
| 2021-02 | 0 | 7.7 |
| 2021-03 | 0 | 8.15 |
| 2021-04 | 0 | 11.47 |
| 2021-05 | 0 | 6.23 |
| 2021-06 | 0 | 7.08 |
| 2021-07 | 1 | 5.92 |
| 2021-08 | 0 | 4.62 |
| 2021-09 | 0 | 3.5 |
| 2021-10 | 0 | 4.13 |
| 2021-11 | 0 | 3.67 |
| 2021-12 | 0 | 4 |
| 2022-01 | 2 | 3.69 |
| 2022-02 | 0 | 3.17 |
| 2022-03 | 0 | 6.11 |
| 2022-04 | 0 | 3.33 |
| 2022-05 | 6 | 3.17 |
| 2022-06 | 1 | 2.92 |
| 2022-07 | 0 | 4.58 |
| 2022-08 | 0 | 2.5 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 3.15 |
| 2022-11 | 0 | 3.3 |
| 2022-12 | 0 | 2.83 |
| 2023-01 | 0 | 2.64 |
| 2023-02 | 0 | 2.5 |
| 2023-03 | 0 | 4.7 |
| 2023-04 | 0 | 2.44 |
| 2023-05 | 0 | 2.42 |
| 2023-06 | 0 | 3.11 |
| 2023-07 | 0 | 4.1 |
| 2023-08 | 0 | 6.64 |
| 2023-09 | 1 | 2.11 |
| 2023-10 | 0 | 2.2 |
| 2023-11 | 1 | 2.11 |
| 2023-12 | 0 | 4 |
| 2024-01 | 0 | 4.14 |
| 2024-02 | 1 | 4.75 |
| 2024-03 | 0 | 2.6 |
| 2024-04 | 2 | 2 |
| 2024-05 | 0 | 4.17 |
| 2024-06 | 0 | 4.22 |
| 2024-07 | 0 | 2.6 |
| 2024-08 | 0 | 3.14 |
| 2024-09 | 0 | 2.8 |
| 2024-10 | 0 | 3.91 |
| 2024-11 | 1 | 2.92 |
| 2024-12 | 0 | 3.25 |
| 2025-01 | 0 | 2.44 |
| 2025-02 | 0 | 3.25 |
| 2025-03 | 0 | 3.22 |
| 2025-04 | 0 | 2 |
| 2025-05 | 2 | 2.79 |
| 2025-06 | 3 | 2.2 |
| 2025-07 | 0 | 2.83 |
| 2025-08 | 1 | 1.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 2.63 |
| 2025-11 | 0 | 2 |
| 2025-12 | 0 | 2.2 |
| 2026-01 | 0 | 3.43 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 2.57 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2.57 |
| 2026-06 | 0 | 2.4 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-25 | 0002249697-2025-00913 | Injury | Available | exact di |
| 2025-06-26 | 0002249697-2025-00641 | Malfunction | Available | exact di |
| 2025-06-02 | 22122388 | Malfunction | Available | catalog number |
| 2025-05-19 | 0002249697-2025-00518 | Injury | Available | exact di |
| 2025-05-15 | 0002249697-2025-00488 | Injury | Available | exact di |
| 2024-11-12 | 0002249697-2024-01544 | Injury | Available | exact di |
| 2024-04-03 | 0002249697-2024-00544 | Death | Available | exact di |
| 2024-04-03 | 0002249697-2024-00545 | Death | Available | exact di |
| 2024-02-26 | 0002249697-2024-00296 | Injury | Available | exact di |
| 2023-11-29 | MW5148578 | Malfunction | Available | model number |
| 2023-09-21 | 0002249697-2023-01058 | Injury | Available | exact di |
| 2022-06-17 | 0002249697-2022-00857 | Injury | Available | exact di |
| 2022-05-30 | 0002249697-2022-00779 | Injury | Available | exact di |
| 2022-05-30 | 0002249697-2022-00778 | Injury | Available | exact di |
| 2022-05-25 | 0002249697-2022-00756 | Injury | Available | exact di |
Showing the most recent 51 of 52 linked reports.
Showing 1–15 of 51
Regulatory clearances
Predicate lineage
K062553
Cited as predicate by: K170802
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 |
|---|---|---|---|---|
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2021-06-22 | NAI | No action indicated | Howmedica Osteonics Corp. | 0 |
| 2015-03-09 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 3 |
| 2013-04-16 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 3 |
| 2010-01-15 | NAI | No action indicated | Howmedica Osteonics Corp. | 0 |
Similar devices
- Arthrex Bone Cement HV G21 SRL
- Arthrex Bone Cement HV G21 SRL
- Arthrex Bone Cement HV w/G G21 SRL
- Arthrex Bone Cement MV G21 SRL
- Arthrex Bone Cement MV G21 SRL
- Arthrex Bone Cement MV w/G G21 SRL
- AutoPlex VertaPlex STRYKER CORPORATION
- AutoPlex, VertaPlex STRYKER CORPORATION
- AutoPlex, VertaPlex STRYKER CORPORATION
- BIOMET® BONE CEMENT R BIOMET
- BIOMET® BONE CEMENT R BIOMET
- BONE CEMENT ACETABULAR GOUGE, 20MM BIOPRO, INC.
Select up to two to place side-by-side with this device.