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.
78 linked reportsInjury 60Malfunction 18
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 5.15 |
| 2019-02 | 0 | 6.5 |
| 2019-03 | 0 | 3.86 |
| 2019-04 | 0 | 6.82 |
| 2019-05 | 0 | 4.46 |
| 2019-06 | 0 | 6.95 |
| 2019-07 | 0 | 7.15 |
| 2019-08 | 0 | 15.71 |
| 2019-09 | 0 | 15.88 |
| 2019-10 | 0 | 29.33 |
| 2019-11 | 0 | 38.28 |
| 2019-12 | 0 | 27.82 |
| 2020-01 | 1 | 21.91 |
| 2020-02 | 0 | 12.06 |
| 2020-03 | 1 | 11 |
| 2020-04 | 0 | 6.62 |
| 2020-05 | 0 | 6.43 |
| 2020-06 | 0 | 9.29 |
| 2020-07 | 1 | 5.7 |
| 2020-08 | 0 | 5.45 |
| 2020-09 | 1 | 6.17 |
| 2020-10 | 3 | 3.82 |
| 2020-11 | 0 | 20.25 |
| 2020-12 | 0 | 7.19 |
| 2021-01 | 0 | 5.61 |
| 2021-02 | 0 | 8.4 |
| 2021-03 | 0 | 10.05 |
| 2021-04 | 2 | 12.86 |
| 2021-05 | 0 | 7.2 |
| 2021-06 | 0 | 7.63 |
| 2021-07 | 1 | 6.65 |
| 2021-08 | 2 | 4.8 |
| 2021-09 | 0 | 3.73 |
| 2021-10 | 1 | 4.12 |
| 2021-11 | 0 | 4.33 |
| 2021-12 | 0 | 4.55 |
| 2022-01 | 2 | 4.17 |
| 2022-02 | 0 | 3.5 |
| 2022-03 | 3 | 6.36 |
| 2022-04 | 0 | 3.54 |
| 2022-05 | 2 | 3.24 |
| 2022-06 | 2 | 2.72 |
| 2022-07 | 5 | 4.68 |
| 2022-08 | 0 | 2.59 |
| 2022-09 | 0 | 2.14 |
| 2022-10 | 1 | 3.6 |
| 2022-11 | 2 | 3.5 |
| 2022-12 | 1 | 2.75 |
| 2023-01 | 2 | 2.36 |
| 2023-02 | 3 | 2.38 |
| 2023-03 | 0 | 5.07 |
| 2023-04 | 1 | 2.5 |
| 2023-05 | 1 | 2.42 |
| 2023-06 | 0 | 3.43 |
| 2023-07 | 1 | 3.54 |
| 2023-08 | 1 | 8.06 |
| 2023-09 | 0 | 2.5 |
| 2023-10 | 0 | 2.25 |
| 2023-11 | 2 | 2.14 |
| 2023-12 | 0 | 3.67 |
| 2024-01 | 0 | 4.64 |
| 2024-02 | 0 | 4.91 |
| 2024-03 | 0 | 2.64 |
| 2024-04 | 0 | 1.86 |
| 2024-05 | 0 | 4.38 |
| 2024-06 | 1 | 3.92 |
| 2024-07 | 8 | 3.5 |
| 2024-08 | 0 | 3.67 |
| 2024-09 | 4 | 2.79 |
| 2024-10 | 0 | 3.93 |
| 2024-11 | 0 | 3.24 |
| 2024-12 | 1 | 3.58 |
| 2025-01 | 1 | 2.38 |
| 2025-02 | 3 | 3.14 |
| 2025-03 | 10 | 3.46 |
| 2025-04 | 1 | 2 |
| 2025-05 | 4 | 3.05 |
| 2025-06 | 0 | 2.13 |
| 2025-07 | 0 | 2.56 |
| 2025-08 | 0 | 1.8 |
| 2025-09 | 1 | 1.4 |
| 2025-10 | 2 | 2.92 |
| 2025-11 | 0 | 2.13 |
| 2025-12 | 0 | 2.25 |
| 2026-01 | 0 | 3.89 |
| 2026-02 | 0 | 2.14 |
| 2026-03 | 0 | 2.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2.36 |
| 2026-06 | 0 | 2.38 |
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 |
|---|---|---|---|---|
| 2025-10-15 | 3006946279-2025-00119 | Injury | Available | exact di |
| 2025-10-15 | 3006946279-2025-00120 | Injury | Available | exact di |
| 2025-09-10 | 3006946279-2025-00104 | Injury | Available | exact di |
| 2025-05-27 | 3006946279-2025-00062 | Injury | Available | exact di |
| 2025-05-27 | 3006946279-2025-00061 | Injury | Available | exact di |
| 2025-05-27 | 3006946279-2025-00063 | Injury | Available | exact di |
| 2025-05-21 | 3006946279-2025-00057 | Injury | Available | exact di |
| 2025-04-02 | 3006946279-2025-00029 | Injury | Available | exact di |
| 2025-03-28 | 3006946279-2025-00035 | Injury | Available | exact di |
| 2025-03-28 | 3006946279-2025-00037 | Injury | Available | exact di |
| 2025-03-28 | 3006946279-2025-00038 | Injury | Available | exact di |
| 2025-03-28 | 3006946279-2025-00036 | Injury | Available | exact di |
| 2025-03-28 | 3006946279-2025-00039 | Injury | Available | exact di |
| 2025-03-28 | 3006946279-2025-00034 | Injury | Available | exact di |
| 2025-03-27 | 3006946279-2025-00033 | Injury | Available | exact di |
Showing 1–15 of 78
Regulatory clearances
- 510(k)K171540Substantially equivalent (SESE) · 2017-08-30clearance family
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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