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 Cementless Shoulder System03701037301067
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.
15 linked reportsInjury 15
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-02 | 1 | — |
| 2021-03 | 1 | — |
| 2021-05 | 1 | — |
| 2021-08 | 1 | — |
| 2021-12 | 1 | — |
| 2022-09 | 1 | — |
| 2023-01 | 1 | — |
| 2023-04 | 1 | — |
| 2023-11 | 1 | — |
| 2024-06 | 3 | — |
| 2024-12 | 1 | — |
| 2026-03 | 2 | — |
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-30 | 3009532798-2026-00011 | Injury | Available | exact di |
| 2026-03-17 | 3009532798-2026-00010 | Injury | Available | exact di |
| 2024-12-13 | 3009532798-2024-00130 | Injury | Available | exact di |
| 2024-06-26 | 3009532798-2024-00071 | Injury | Available | exact di |
| 2024-06-26 | 3009532798-2024-00072 | Injury | Available | exact di |
| 2024-06-19 | 3009532798-2024-00065 | Injury | Available | exact di |
| 2023-11-20 | 3009532798-2023-00114 | Injury | Available | exact di |
| 2023-04-13 | 3009532798-2023-00021 | Injury | Available | exact di |
| 2023-01-12 | 3009532798-2023-00002 | Injury | Available | exact di |
| 2022-09-09 | 3009532798-2022-00125 | Injury | Available | exact di |
| 2021-12-24 | 3009532798-2021-00183 | Injury | Available | exact di |
| 2021-08-05 | 3009532798-2021-00114 | Injury | Available | exact di |
| 2021-05-10 | 3009532798-2021-00056 | Injury | Available | exact di |
| 2021-03-18 | 3009532798-2021-00038 | Injury | Available | exact di |
| 2021-02-15 | 3009532798-2021-00012 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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