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 Shoulder03701037301357
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.
40 linked reportsInjury 40
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-03 | 1 | — |
| 2021-05 | 1 | — |
| 2021-07 | 1 | — |
| 2021-09 | 2 | — |
| 2021-10 | 4 | — |
| 2021-12 | 1 | — |
| 2022-01 | 2 | — |
| 2022-02 | 4 | — |
| 2022-03 | 2 | — |
| 2022-04 | 4 | — |
| 2022-06 | 1 | — |
| 2023-04 | 1 | — |
| 2023-05 | 2 | — |
| 2023-08 | 1 | — |
| 2023-09 | 1 | — |
| 2024-01 | 1 | — |
| 2024-02 | 1 | — |
| 2024-03 | 1 | — |
| 2024-06 | 1 | — |
| 2024-09 | 1 | — |
| 2024-11 | 1 | — |
| 2025-01 | 1 | — |
| 2025-04 | 1 | — |
| 2025-06 | 1 | — |
| 2025-12 | 1 | — |
| 2026-02 | 1 | — |
| 2026-06 | 1 | — |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-08 | 3009532798-2026-00024 | Injury | Available | exact di |
| 2026-02-16 | 3009532798-2026-00006 | Injury | Available | exact di |
| 2025-12-15 | 3009532798-2025-00070 | Injury | Available | exact di |
| 2025-06-06 | 3009532798-2025-00036 | Injury | Available | exact di |
| 2025-04-03 | 3009532798-2025-00020 | Injury | Available | exact di |
| 2025-01-29 | 3009532798-2025-00003 | Injury | Available | exact di |
| 2024-11-13 | 3009532798-2024-00120 | Injury | Available | exact di |
| 2024-09-16 | 3009532798-2024-00097 | Injury | Available | exact di |
| 2024-06-17 | 3009532798-2024-00064 | Injury | Available | exact di |
| 2024-03-18 | 3009532798-2024-00023 | Injury | Available | exact di |
| 2024-02-16 | 3014128390-2024-00011 | Injury | Available | exact di |
| 2024-01-11 | 3009532798-2023-00142 | Injury | Available | exact di |
| 2023-09-14 | 3009532798-2023-00084 | Injury | Available | exact di |
| 2023-08-01 | 3009532798-2023-00075 | Injury | Available | exact di |
| 2023-05-29 | 3009532798-2023-00039 | Injury | Available | exact di |
Showing 1–15 of 40
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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