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 Shoulder03701037300138
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.
14 linked reportsInjury 14
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-03 | 1 | — |
| 2022-04 | 1 | — |
| 2023-05 | 1 | — |
| 2023-06 | 1 | — |
| 2023-07 | 1 | — |
| 2023-10 | 1 | — |
| 2023-11 | 2 | — |
| 2024-04 | 1 | — |
| 2024-05 | 1 | — |
| 2024-06 | 1 | — |
| 2024-09 | 1 | — |
| 2025-04 | 1 | — |
| 2026-03 | 1 | — |
Failure-mode summaryAI-generated
14 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-02 | 3009532798-2026-00007 | Injury | Available | exact di |
| 2025-04-04 | 3009532798-2025-00022 | Injury | Available | exact di |
| 2024-09-06 | 3009532798-2024-00093 | Injury | Available | exact di |
| 2024-06-27 | 3014128390-2024-00033 | Injury | Available | exact di |
| 2024-05-03 | 3009532798-2024-00047 | Injury | Available | exact di |
| 2024-04-05 | 3014128390-2024-00021 | Injury | Available | exact di |
| 2023-11-09 | 3009532798-2023-00107 | Injury | Available | exact di |
| 2023-11-03 | 3014128390-2023-00038 | Injury | Available | exact di |
| 2023-10-18 | 3014128390-2023-00031 | Injury | Available | exact di |
| 2023-07-11 | 3009532798-2023-00060 | Injury | Available | exact di |
| 2023-06-07 | 3009532798-2023-00046 | Injury | Available | exact di |
| 2023-05-23 | 3009532798-2023-00033 | Injury | Available | exact di |
| 2022-04-04 | 3009532798-2022-00096 | Injury | Available | exact di |
| 2022-03-25 | 3009532798-2022-00060 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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