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.
97 linked reportsInjury 86Malfunction 8Death 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.71 |
| 2019-02 | 0 | 5.36 |
| 2019-03 | 0 | 3.38 |
| 2019-04 | 0 | 5.83 |
| 2019-05 | 0 | 3.67 |
| 2019-06 | 0 | 6.08 |
| 2019-07 | 0 | 6.23 |
| 2019-08 | 0 | 13.93 |
| 2019-09 | 0 | 14.91 |
| 2019-10 | 0 | 23.47 |
| 2019-11 | 0 | 34.33 |
| 2019-12 | 0 | 24.64 |
| 2020-01 | 1 | 19.47 |
| 2020-02 | 0 | 10.83 |
| 2020-03 | 1 | 9.93 |
| 2020-04 | 0 | 6.62 |
| 2020-05 | 0 | 5.7 |
| 2020-06 | 0 | 9.11 |
| 2020-07 | 0 | 5.53 |
| 2020-08 | 0 | 4.22 |
| 2020-09 | 0 | 6.07 |
| 2020-10 | 0 | 3.82 |
| 2020-11 | 0 | 18.75 |
| 2020-12 | 0 | 6.3 |
| 2021-01 | 0 | 5.33 |
| 2021-02 | 0 | 7.7 |
| 2021-03 | 1 | 8.15 |
| 2021-04 | 0 | 11.47 |
| 2021-05 | 2 | 6.23 |
| 2021-06 | 3 | 7.08 |
| 2021-07 | 1 | 5.92 |
| 2021-08 | 1 | 4.62 |
| 2021-09 | 2 | 3.5 |
| 2021-10 | 0 | 4.13 |
| 2021-11 | 1 | 3.67 |
| 2021-12 | 0 | 4 |
| 2022-01 | 3 | 3.69 |
| 2022-02 | 0 | 3.17 |
| 2022-03 | 1 | 6.11 |
| 2022-04 | 0 | 3.33 |
| 2022-05 | 1 | 3.17 |
| 2022-06 | 7 | 2.92 |
| 2022-07 | 2 | 4.58 |
| 2022-08 | 0 | 2.5 |
| 2022-09 | 2 | 2.11 |
| 2022-10 | 1 | 3.15 |
| 2022-11 | 1 | 3.3 |
| 2022-12 | 0 | 2.83 |
| 2023-01 | 2 | 2.64 |
| 2023-02 | 3 | 2.5 |
| 2023-03 | 5 | 4.7 |
| 2023-04 | 0 | 2.44 |
| 2023-05 | 0 | 2.42 |
| 2023-06 | 1 | 3.11 |
| 2023-07 | 3 | 4.1 |
| 2023-08 | 0 | 6.64 |
| 2023-09 | 2 | 2.11 |
| 2023-10 | 0 | 2.2 |
| 2023-11 | 5 | 2.11 |
| 2023-12 | 1 | 4 |
| 2024-01 | 0 | 4.14 |
| 2024-02 | 0 | 4.75 |
| 2024-03 | 3 | 2.6 |
| 2024-04 | 0 | 2 |
| 2024-05 | 1 | 4.17 |
| 2024-06 | 2 | 4.22 |
| 2024-07 | 0 | 2.6 |
| 2024-08 | 1 | 3.14 |
| 2024-09 | 0 | 2.8 |
| 2024-10 | 1 | 3.91 |
| 2024-11 | 3 | 2.92 |
| 2024-12 | 0 | 3.25 |
| 2025-01 | 3 | 2.44 |
| 2025-02 | 4 | 3.25 |
| 2025-03 | 2 | 3.22 |
| 2025-04 | 2 | 2 |
| 2025-05 | 0 | 2.79 |
| 2025-06 | 3 | 2.2 |
| 2025-07 | 2 | 2.83 |
| 2025-08 | 1 | 1.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 2.63 |
| 2025-11 | 2 | 2 |
| 2025-12 | 3 | 2.2 |
| 2026-01 | 1 | 3.43 |
| 2026-02 | 0 | 2 |
| 2026-03 | 3 | 2.57 |
| 2026-04 | 1 | 2 |
| 2026-05 | 6 | 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 |
|---|---|---|---|---|
| 2026-05-25 | 3006946279-2026-00025 | Injury | Available | exact di |
| 2026-05-25 | 3006946279-2026-00026 | Injury | Available | exact di |
| 2026-05-12 | 3006946279-2026-00024 | Injury | Available | exact di |
| 2026-05-12 | 3006946279-2026-00023 | Injury | Available | exact di |
| 2026-05-11 | 3006946279-2026-00021 | Injury | Available | exact di |
| 2026-05-11 | 3006946279-2026-00022 | Injury | Available | exact di |
| 2026-04-24 | 3006946279-2026-00018 | Malfunction | Available | exact di |
| 2026-03-03 | 3006946279-2026-00011 | Injury | Available | exact di |
| 2026-03-03 | 3006946279-2026-00012 | Injury | Available | exact di |
| 2026-03-02 | 3006946279-2026-00010 | Injury | Available | exact di |
| 2026-01-05 | 3006946279-2026-00001 | Injury | Available | exact di |
| 2025-12-10 | 3006946279-2025-00129 | Injury | Available | exact di |
| 2025-12-10 | 3006946279-2025-00128 | Injury | Available | exact di |
| 2025-12-05 | 3006946279-2025-00127 | Injury | Available | exact di |
| 2025-11-26 | 3006946279-2025-00125 | Injury | Available | exact di |
Showing 1–15 of 97
Regulatory clearances
- 510(k)K172408Substantially equivalent (SESE) · 2017-10-05clearance family
Predicate lineage
- K172408
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 |
|---|---|---|---|---|
| 2023-11-09 | VAI | Voluntary action indicated | Biomet, Inc. | 0 |
| 2023-11-09 | VAI | Voluntary action indicated | Biomet, Inc. | 0 |
| 2020-01-30 | VAI | Voluntary action indicated | Biomet, Inc. | 8 |
| 2020-01-30 | VAI | Voluntary action indicated | Biomet, Inc. | 8 |
| 2018-08-24 | WL | Warning Letter | Biomet, Inc. | — |
| 2018-08-24 | WL | Warning Letter | Biomet, Inc. | — |
| 2018-04-24 | OAI | Official action indicated | Biomet, Inc. | 11 |
| 2018-04-24 | OAI | Official action indicated | Biomet, Inc. | 11 |
| 2017-08-17 | NAI | No action indicated | Zhejiang Biomet Medical Products Co. Ltd. | 0 |
| 2017-08-03 | VAI | Voluntary action indicated | Biomet UK Ltd. | 4 |
| 2017-02-10 | NAI | No action indicated | Biomet | 0 |
| 2017-02-03 | NAI | No action indicated | Biomet France SARL | 0 |
| 2016-11-22 | OAI | Official action indicated | Biomet, Inc. | 14 |
| 2016-11-22 | OAI | Official action indicated | Biomet, Inc. | 14 |
| 2016-03-24 | NAI | No action indicated | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. | 0 |
| 2015-06-03 | WL | Warning Letter | Zhejiang Biomet Medical Products Co. Ltd. | — |
| 2015-03-18 | VAI | Voluntary action indicated | Biomet UK Ltd. | 2 |
| 2015-01-22 | OAI | Official action indicated | Zhejiang Biomet Medical Products Co. Ltd. | 0 |
| 2014-06-30 | VAI | Voluntary action indicated | Biomet, Inc. | 2 |
| 2014-06-30 | VAI | Voluntary action indicated | Biomet, Inc. | 2 |
| 2013-01-18 | NAI | No action indicated | Biomet | 0 |
| 2010-07-27 | WL | Warning Letter | Biomet, Inc. | — |
| 2010-07-27 | WL | Warning Letter | Biomet, Inc. | — |
| 2010-03-26 | NAI | No action indicated | Biomet, Inc. | 0 |
| 2010-03-26 | NAI | No action indicated | Biomet, Inc. | 0 |
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