Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesHumelock II Cemented Reversible Shoulder03701037300268
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.
61 linked reportsInjury 61
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-03 | 2 | — |
| 2021-04 | 2 | — |
| 2021-05 | 2 | — |
| 2021-07 | 1 | — |
| 2021-08 | 1 | — |
| 2021-10 | 1 | — |
| 2021-11 | 2 | — |
| 2021-12 | 7 | — |
| 2022-01 | 2 | — |
| 2022-02 | 2 | — |
| 2022-03 | 2 | — |
| 2022-06 | 1 | — |
| 2022-07 | 1 | — |
| 2022-09 | 2 | — |
| 2023-04 | 3 | — |
| 2023-06 | 1 | — |
| 2023-10 | 4 | — |
| 2023-12 | 1 | — |
| 2024-01 | 2 | — |
| 2024-03 | 3 | — |
| 2024-04 | 2 | — |
| 2024-05 | 3 | — |
| 2024-10 | 1 | — |
| 2024-12 | 1 | — |
| 2025-01 | 2 | — |
| 2025-03 | 1 | — |
| 2025-04 | 1 | — |
| 2025-05 | 2 | — |
| 2025-07 | 1 | — |
| 2025-09 | 1 | — |
| 2025-10 | 1 | — |
| 2025-12 | 1 | — |
| 2026-05 | 1 | — |
| 2026-06 | 1 | — |
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 |
|---|---|---|---|---|
| 2026-06-12 | 3014128390-2026-00020 | Injury | Available | exact di |
| 2026-05-29 | 3014128390-2026-00019 | Injury | Available | exact di |
| 2025-12-12 | 3014128390-2025-00089 | Injury | Available | exact di |
| 2025-10-17 | 3014128390-2025-00072 | Injury | Available | exact di |
| 2025-09-04 | 3014128390-2025-00053 | Injury | Available | exact di |
| 2025-07-15 | 3014128390-2025-00042 | Injury | Available | exact di |
| 2025-05-15 | 3014128390-2025-00022 | Injury | Available | exact di |
| 2025-05-09 | 3014128390-2025-00021 | Injury | Available | exact di |
| 2025-04-30 | 3014128390-2025-00018 | Injury | Available | exact di |
| 2025-03-21 | 3014128390-2025-00012 | Injury | Available | exact di |
| 2025-01-29 | 3014128390-2025-00006 | Injury | Available | exact di |
| 2025-01-15 | 3014128390-2025-00002 | Injury | Available | exact di |
| 2024-12-05 | 3014128390-2024-00065 | Injury | Available | exact di |
| 2024-10-02 | 3014128390-2024-00050 | Injury | Available | exact di |
| 2024-05-27 | 3009532798-2024-00056 | Injury | Available | exact di |
Showing 1–15 of 61
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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