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 Shoulder03701037300114
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.
20 linked reportsInjury 20
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-07 | 1 | — |
| 2021-12 | 2 | — |
| 2022-01 | 1 | — |
| 2022-02 | 1 | — |
| 2022-03 | 4 | — |
| 2022-04 | 1 | — |
| 2022-08 | 1 | — |
| 2023-08 | 1 | — |
| 2023-09 | 1 | — |
| 2023-12 | 1 | — |
| 2024-01 | 2 | — |
| 2024-02 | 1 | — |
| 2024-05 | 1 | — |
| 2025-07 | 1 | — |
| 2026-05 | 1 | — |
Failure-mode summaryAI-generated
20 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-11 | 3009532798-2026-00019 | Injury | Available | exact di |
| 2025-07-01 | 3009532798-2025-00046 | Injury | Available | exact di |
| 2024-05-10 | 3014128390-2024-00026 | Injury | Available | exact di |
| 2024-02-27 | 3009532798-2024-00011 | Injury | Available | exact di |
| 2024-01-22 | 3014128390-2024-00005 | Injury | Available | exact di |
| 2024-01-19 | 3009532798-2023-00146 | Injury | Available | exact di |
| 2023-12-12 | 3014128390-2023-00043 | Injury | Available | exact di |
| 2023-09-28 | 3009532798-2023-00088 | Injury | Available | exact di |
| 2023-08-01 | 3009532798-2023-00071 | Injury | Available | exact di |
| 2022-08-04 | 3009532798-2022-00124 | Injury | Available | exact di |
| 2022-04-05 | 3009532798-2022-00098 | Injury | Available | exact di |
| 2022-03-25 | 3009532798-2022-00071 | Injury | Available | exact di |
| 2022-03-14 | 3014128390-2022-00006 | Injury | Available | exact di |
| 2022-03-02 | 3009532798-2022-00044 | Injury | Available | exact di |
| 2022-03-02 | 3009532798-2022-00051 | Injury | Available | exact di |
Showing 1–15 of 20
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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