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 Shoulder03701037300237
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.
28 linked reportsInjury 27Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-03 | 2 | — |
| 2021-04 | 1 | — |
| 2021-05 | 2 | — |
| 2021-08 | 2 | — |
| 2021-09 | 1 | — |
| 2021-11 | 1 | — |
| 2021-12 | 3 | — |
| 2022-01 | 3 | — |
| 2022-02 | 2 | — |
| 2022-03 | 5 | — |
| 2022-04 | 1 | — |
| 2022-12 | 1 | — |
| 2023-05 | 1 | — |
| 2023-10 | 1 | — |
| 2023-11 | 1 | — |
| 2024-10 | 1 | — |
Failure-mode summaryAI-generated
28 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-10-02 | 3014128390-2024-00049 | Injury | Available | exact di |
| 2023-11-23 | 3009532798-2023-00117 | Injury | Available | exact di |
| 2023-10-18 | 3014128390-2023-00029 | Injury | Available | exact di |
| 2023-05-24 | 3009532798-2023-00037 | Injury | Available | exact di |
| 2022-12-14 | 3009532798-2022-00137 | Injury | Available | exact di |
| 2022-04-25 | 3014128390-2022-00017 | Injury | Available | exact di |
| 2022-03-25 | 3009532798-2022-00005 | Injury | Available | exact di |
| 2022-03-25 | 3009532798-2022-00057 | Injury | Available | exact di |
| 2022-03-18 | 3014128390-2022-00009 | Injury | Available | exact di |
| 2022-03-14 | 3014128390-2022-00007 | Injury | Available | exact di |
| 2022-03-03 | 3009532798-2022-00036 | Injury | Available | exact di |
| 2022-02-07 | 3009532798-2022-00016 | Injury | Available | exact di |
| 2022-02-03 | 3009532798-2021-00252 | Injury | Available | exact di |
| 2022-01-31 | 3009532798-2022-00006 | Injury | Available | exact di |
| 2022-01-28 | 3009532798-2021-00273 | Injury | Available | exact di |
Showing 1–15 of 28
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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