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 Shoulder System03701037300732
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.
5 linked reportsInjury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-11 | 1 | — |
| 2022-01 | 1 | — |
| 2022-11 | 1 | — |
| 2023-03 | 1 | — |
| 2023-12 | 1 | — |
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-12-18 | 3009532798-2023-00128 | Injury | Available | exact di |
| 2023-03-02 | 3009532798-2023-00010 | Injury | Available | exact di |
| 2022-11-14 | 3009532798-2022-00131 | Injury | Available | exact di |
| 2022-01-06 | 3009532798-2021-00237 | Injury | Available | exact di |
| 2021-11-25 | 3009532798-2021-00190 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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