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 Shoulder03701037300305
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) |
|---|---|---|
| 2021-05 | 1 | — |
| 2021-09 | 2 | — |
| 2021-12 | 1 | — |
| 2022-01 | 1 | — |
| 2022-02 | 1 | — |
| 2022-03 | 1 | — |
| 2023-10 | 1 | — |
| 2024-01 | 1 | — |
| 2025-02 | 1 | — |
| 2025-06 | 1 | — |
| 2025-10 | 1 | — |
| 2026-05 | 1 | — |
| 2026-06 | 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 |
|---|---|---|---|---|
| 2026-06-15 | 3014128390-2026-00024 | Injury | Available | exact di |
| 2026-05-07 | 3014128390-2026-00013 | Injury | Available | exact di |
| 2025-10-17 | 3014128390-2025-00070 | Injury | Available | exact di |
| 2025-06-18 | 3009532798-2025-00041 | Injury | Available | exact di |
| 2025-02-06 | 3014128390-2025-00007 | Injury | Available | exact di |
| 2024-01-23 | 3009532798-2024-00001 | Injury | Available | exact di |
| 2023-10-13 | 3009532798-2023-00092 | Injury | Available | exact di |
| 2022-03-02 | 3009532798-2022-00046 | Injury | Available | exact di |
| 2022-02-01 | 3009532798-2021-00268 | Injury | Available | exact di |
| 2022-01-28 | 3009532798-2021-00259 | Injury | Available | exact di |
| 2021-12-24 | 3009532798-2021-00211 | Injury | Available | exact di |
| 2021-09-10 | 3009532798-2021-00138 | Injury | Available | exact di |
| 2021-09-01 | 3009532798-2021-00124 | Injury | Available | exact di |
| 2021-05-11 | 3009532798-2021-00053 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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