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 Shoulder03701037301364
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.
21 linked reportsInjury 21
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-02 | 1 | — |
| 2021-03 | 1 | — |
| 2021-05 | 2 | — |
| 2021-08 | 2 | — |
| 2021-10 | 1 | — |
| 2021-12 | 1 | — |
| 2022-01 | 3 | — |
| 2022-04 | 4 | — |
| 2022-07 | 1 | — |
| 2022-08 | 1 | — |
| 2022-12 | 1 | — |
| 2023-05 | 1 | — |
| 2024-11 | 1 | — |
| 2026-05 | 1 | — |
Failure-mode summaryAI-generated
21 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-05 | 3009532798-2026-00017 | Injury | Available | exact di |
| 2024-11-27 | 3009532798-2024-00127 | Injury | Available | exact di |
| 2023-05-29 | 3009532798-2023-00040 | Injury | Available | exact di |
| 2022-12-02 | 3009532798-2022-00135 | Injury | Available | exact di |
| 2022-08-03 | 3009532798-2022-00120 | Injury | Available | exact di |
| 2022-07-07 | 3014128390-2022-00021 | Injury | Available | exact di |
| 2022-04-08 | 3014128390-2022-00015 | Injury | Available | exact di |
| 2022-04-04 | 3009532798-2022-00092 | Injury | Available | exact di |
| 2022-04-04 | 3009532798-2022-00090 | Injury | Available | exact di |
| 2022-04-04 | 3009532798-2022-00093 | Injury | Available | exact di |
| 2022-01-31 | 3009532798-2021-00266 | Injury | Available | exact di |
| 2022-01-05 | 3009532798-2021-00245 | Injury | Available | exact di |
| 2022-01-04 | 3014128390-2021-00076 | Injury | Available | exact di |
| 2021-12-10 | 3014128390-2021-00065 | Injury | Available | exact di |
| 2021-10-08 | 3009532798-2021-00145 | Injury | Available | exact di |
Showing 1–15 of 21
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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