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 Shoulder03701037300091
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.
85 linked reportsInjury 85
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-02 | 2 | — |
| 2021-04 | 1 | — |
| 2021-08 | 1 | — |
| 2021-09 | 1 | — |
| 2021-10 | 3 | — |
| 2021-12 | 4 | — |
| 2022-01 | 2 | — |
| 2022-03 | 13 | — |
| 2022-04 | 7 | — |
| 2022-06 | 3 | — |
| 2022-12 | 1 | — |
| 2023-01 | 2 | — |
| 2023-03 | 1 | — |
| 2023-05 | 2 | — |
| 2023-06 | 3 | — |
| 2023-07 | 4 | — |
| 2023-08 | 1 | — |
| 2023-10 | 1 | — |
| 2023-11 | 2 | — |
| 2023-12 | 2 | — |
| 2024-02 | 1 | — |
| 2024-04 | 1 | — |
| 2024-05 | 1 | — |
| 2024-06 | 1 | — |
| 2024-07 | 1 | — |
| 2024-09 | 1 | — |
| 2024-10 | 5 | — |
| 2024-11 | 2 | — |
| 2025-01 | 1 | — |
| 2025-04 | 1 | — |
| 2025-06 | 2 | — |
| 2025-07 | 1 | — |
| 2025-10 | 3 | — |
| 2025-11 | 1 | — |
| 2026-01 | 1 | — |
| 2026-04 | 1 | — |
| 2026-05 | 1 | — |
| 2026-06 | 4 | — |
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 |
|---|---|---|---|---|
| 2026-06-29 | 3009532798-2026-00031 | Injury | Available | exact di |
| 2026-06-23 | 3009532798-2026-00027 | Injury | Available | exact di |
| 2026-06-15 | 3014128390-2026-00023 | Injury | Available | exact di |
| 2026-06-08 | 3009532798-2026-00025 | Injury | Available | exact di |
| 2026-05-12 | 3009532798-2026-00021 | Injury | Available | exact di |
| 2026-04-14 | 3014128390-2026-00009 | Injury | Available | exact di |
| 2026-01-23 | 3014128390-2026-00002 | Injury | Available | exact di |
| 2025-11-13 | 3009532798-2025-00066 | Injury | Available | exact di |
| 2025-10-17 | 3009532798-2025-00061 | Injury | Available | exact di |
| 2025-10-17 | 3014128390-2025-00069 | Injury | Available | exact di |
| 2025-10-16 | 3009532798-2025-00059 | Injury | Available | exact di |
| 2025-07-17 | 3014128390-2025-00045 | Injury | Available | exact di |
| 2025-06-19 | 3009532798-2025-00042 | Injury | Available | exact di |
| 2025-06-09 | 3009532798-2025-00037 | Injury | Available | exact di |
| 2025-04-22 | 3009532798-2025-00027 | Injury | Available | exact di |
Showing 1–15 of 85
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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