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 Shoulder03701037300107
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.
38 linked reportsInjury 38
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-02 | 1 | — |
| 2021-03 | 1 | — |
| 2021-05 | 1 | — |
| 2021-09 | 1 | — |
| 2021-11 | 1 | — |
| 2021-12 | 2 | — |
| 2022-01 | 3 | — |
| 2022-02 | 1 | — |
| 2022-04 | 1 | — |
| 2022-05 | 1 | — |
| 2023-04 | 1 | — |
| 2023-05 | 1 | — |
| 2023-08 | 1 | — |
| 2023-10 | 2 | — |
| 2023-12 | 1 | — |
| 2024-01 | 2 | — |
| 2024-04 | 1 | — |
| 2024-07 | 2 | — |
| 2024-08 | 1 | — |
| 2024-09 | 1 | — |
| 2024-10 | 2 | — |
| 2024-11 | 2 | — |
| 2025-02 | 1 | — |
| 2025-03 | 1 | — |
| 2025-05 | 1 | — |
| 2025-06 | 2 | — |
| 2025-07 | 1 | — |
| 2025-12 | 1 | — |
| 2026-06 | 1 | — |
Failure-mode summaryAI-generated
38 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-25 | 3014128390-2026-00031 | Injury | Available | exact di |
| 2025-12-15 | 3009532798-2025-00071 | Injury | Available | exact di |
| 2025-07-21 | 3009532798-2025-00051 | Injury | Available | exact di |
| 2025-06-16 | 3009532798-2025-00039 | Injury | Available | exact di |
| 2025-06-06 | 3014128390-2025-00032 | Injury | Available | exact di |
| 2025-05-06 | 3009532798-2025-00032 | Injury | Available | exact di |
| 2025-03-03 | 3009532798-2025-00012 | Injury | Available | exact di |
| 2025-02-18 | 3009532798-2025-00009 | Injury | Available | exact di |
| 2024-11-18 | 3014128390-2024-00062 | Injury | Available | exact di |
| 2024-11-08 | 3014128390-2024-00060 | Injury | Available | exact di |
| 2024-10-10 | 3009532798-2024-00109 | Injury | Available | exact di |
| 2024-10-10 | 3014128390-2024-00052 | Injury | Available | exact di |
| 2024-09-16 | 3009532798-2024-00098 | Injury | Available | exact di |
| 2024-08-09 | 3014128390-2024-00040 | Injury | Available | exact di |
| 2024-07-15 | 3009532798-2024-00080 | Injury | Available | exact di |
Showing 1–15 of 38
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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