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 StatesTiN Coated Glenosphere03701037300800
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.
18 linked reportsInjury 18
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-02 | 1 | — |
| 2022-03 | 1 | — |
| 2023-10 | 3 | — |
| 2023-11 | 1 | — |
| 2024-01 | 1 | — |
| 2024-03 | 1 | — |
| 2024-04 | 1 | — |
| 2024-09 | 1 | — |
| 2025-03 | 1 | — |
| 2025-06 | 2 | — |
| 2025-09 | 2 | — |
| 2025-10 | 1 | — |
| 2026-01 | 1 | — |
| 2026-06 | 1 | — |
Failure-mode summaryAI-generated
18 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-12 | 3014128390-2026-00022 | Injury | Available | exact di |
| 2026-01-23 | 3014128390-2026-00003 | Injury | Available | exact di |
| 2025-10-16 | 3014128390-2025-00066 | Injury | Available | exact di |
| 2025-09-19 | 3014128390-2025-00056 | Injury | Available | exact di |
| 2025-09-04 | 3014128390-2025-00052 | Injury | Available | exact di |
| 2025-06-12 | 3014128390-2025-00033 | Injury | Available | exact di |
| 2025-06-12 | 3014128390-2025-00035 | Injury | Available | exact di |
| 2025-03-07 | 3014128390-2025-00011 | Injury | Available | exact di |
| 2024-09-26 | 3014128390-2024-00047 | Injury | Available | exact di |
| 2024-04-08 | 3014128390-2024-00020 | Injury | Available | exact di |
| 2024-03-04 | 3009532798-2024-00016 | Injury | Available | exact di |
| 2024-01-03 | 3014128390-2024-00001 | Injury | Available | exact di |
| 2023-11-03 | 3014128390-2023-00039 | Injury | Available | exact di |
| 2023-10-20 | 3014128390-2023-00036 | Injury | Available | exact di |
| 2023-10-19 | 3014128390-2023-00032 | Injury | Available | exact di |
Showing 1–15 of 18
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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