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.
71 linked reportsInjury 70Malfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 2.64 |
| 2019-02 | 0 | 2.28 |
| 2019-03 | 1 | 2.55 |
| 2019-04 | 2 | 2.47 |
| 2019-05 | 2 | 2 |
| 2019-06 | 0 | 1.69 |
| 2019-07 | 1 | 1.71 |
| 2019-08 | 1 | 1.96 |
| 2019-09 | 1 | 2.09 |
| 2019-10 | 2 | 2.27 |
| 2019-11 | 2 | 1.94 |
| 2019-12 | 1 | 2.18 |
| 2020-01 | 1 | 2.46 |
| 2020-02 | 1 | 2.25 |
| 2020-03 | 1 | 2.83 |
| 2020-04 | 0 | 2.02 |
| 2020-05 | 0 | 2.06 |
| 2020-06 | 3 | 1.95 |
| 2020-07 | 0 | 2.51 |
| 2020-08 | 0 | 2.15 |
| 2020-09 | 0 | 2.43 |
| 2020-10 | 1 | 2.48 |
| 2020-11 | 3 | 2.39 |
| 2020-12 | 1 | 2.59 |
| 2021-01 | 0 | 2.6 |
| 2021-02 | 0 | 2.11 |
| 2021-03 | 2 | 1.98 |
| 2021-04 | 1 | 1.99 |
| 2021-05 | 0 | 2.19 |
| 2021-06 | 4 | 2.46 |
| 2021-07 | 0 | 2.32 |
| 2021-08 | 0 | 2.27 |
| 2021-09 | 1 | 2.41 |
| 2021-10 | 1 | 2.17 |
| 2021-11 | 2 | 2.07 |
| 2021-12 | 0 | 2.25 |
| 2022-01 | 1 | 2.04 |
| 2022-02 | 1 | 2.16 |
| 2022-03 | 2 | 2.08 |
| 2022-04 | 1 | 2.15 |
| 2022-05 | 0 | 2.1 |
| 2022-06 | 1 | 2.09 |
| 2022-07 | 0 | 1.98 |
| 2022-08 | 0 | 2.04 |
| 2022-09 | 1 | 2.05 |
| 2022-10 | 2 | 2.06 |
| 2022-11 | 3 | 2.06 |
| 2022-12 | 1 | 1.99 |
| 2023-01 | 0 | 2.11 |
| 2023-02 | 0 | 1.97 |
| 2023-03 | 0 | 2.16 |
| 2023-04 | 1 | 2.09 |
| 2023-05 | 0 | 2.06 |
| 2023-06 | 1 | 2.08 |
| 2023-07 | 0 | 2 |
| 2023-08 | 1 | 1.9 |
| 2023-09 | 0 | 1.9 |
| 2023-10 | 2 | 1.59 |
| 2023-11 | 0 | 1.57 |
| 2023-12 | 1 | 1.64 |
| 2024-01 | 2 | 1.68 |
| 2024-02 | 0 | 1.94 |
| 2024-03 | 1 | 1.9 |
| 2024-04 | 1 | 1.7 |
| 2024-05 | 0 | 2.02 |
| 2024-06 | 0 | 1.86 |
| 2024-07 | 1 | 1.67 |
| 2024-08 | 0 | 1.87 |
| 2024-09 | 1 | 1.94 |
| 2024-10 | 0 | 1.73 |
| 2024-11 | 1 | 1.65 |
| 2024-12 | 0 | 1.53 |
| 2025-01 | 0 | 1.78 |
| 2025-02 | 0 | 1.49 |
| 2025-03 | 0 | 1.76 |
| 2025-04 | 1 | 1.78 |
| 2025-05 | 0 | 1.63 |
| 2025-06 | 2 | 1.78 |
| 2025-07 | 0 | 1.79 |
| 2025-08 | 1 | 1.63 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 1 | 1.7 |
| 2025-11 | 0 | 1.72 |
| 2025-12 | 0 | 1.82 |
| 2026-01 | 1 | 1.89 |
| 2026-02 | 1 | 1.58 |
| 2026-03 | 0 | 1.86 |
| 2026-04 | 0 | 1.79 |
| 2026-05 | 2 | 1.62 |
| 2026-06 | 0 | 1.69 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-12-30 | Z-0652-2022 | Class II | Terminated | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.Distribution: The product was distributed to the following US states: MI | 58 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-27 | 0002249697-2026-00446 | Injury | Available | exact di |
| 2026-05-19 | 0002249697-2026-00408 | Injury | Available | exact di |
| 2026-02-09 | 0002249697-2026-00082 | Injury | Available | exact di |
| 2026-01-28 | 0002249697-2026-00056 | Injury | Available | exact di |
| 2025-10-03 | 0002249697-2025-01051 | Injury | Available | exact di |
| 2025-08-25 | 0002249697-2025-00914 | Injury | Available | exact di |
| 2025-06-17 | 0002249697-2025-00624 | Injury | Available | exact di |
| 2025-06-04 | 0002249697-2025-00586 | Injury | Available | exact di |
| 2025-04-07 | 0002249697-2025-00384 | Injury | Available | exact di |
| 2024-11-13 | 0002249697-2024-01549 | Injury | Available | exact di |
| 2024-09-10 | 0002249697-2024-01232 | Injury | Available | exact di |
| 2024-07-02 | 0002249697-2024-00950 | Injury | Available | exact di |
| 2024-04-24 | 0002249697-2024-00642 | Injury | Available | exact di |
| 2024-03-22 | 0002249697-2024-00484 | Injury | Available | exact di |
| 2024-01-26 | 0002249697-2024-00139 | Injury | Available | exact di |
Showing 1–15 of 71
Regulatory clearances
None linked.
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 |
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