32mm Glenosphere and Humeral Cup · recalls, adverse events, clearances

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.

European UnionB-03701037309360B-03701037309360

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.

1 linked reportInjury 1

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1.91
2019-02	0	1.78
2019-03	0	1.66
2019-04	0	2.06
2019-05	0	2.22
2019-06	0	1.85
2019-07	0	1.74
2019-08	0	2.27
2019-09	0	1.78
2019-10	0	1.89
2019-11	0	1.71
2019-12	0	1.8
2020-01	0	2
2020-02	0	2.08
2020-03	0	2.14
2020-04	0	1.74
2020-05	0	1.84
2020-06	0	2.08
2020-07	1	2.29
2020-08	0	1.94
2020-09	0	2.06
2020-10	0	2.19
2020-11	0	1.96
2020-12	0	1.86
2021-01	0	2.21
2021-02	0	2.04
2021-03	0	2.14
2021-04	0	2.15
2021-05	0	1.96
2021-06	0	1.86
2021-07	0	2.24
2021-08	0	2.37
2021-09	0	2.08
2021-10	0	2.41
2021-11	0	2.12
2021-12	0	2.65
2022-01	0	2.77
2022-02	0	2.62
2022-03	0	2.74
2022-04	0	2.56
2022-05	0	2.15
2022-06	0	2.44
2022-07	0	2.38
2022-08	0	2.3
2022-09	0	2.1
2022-10	0	2.08
2022-11	0	2.09
2022-12	0	2.14
2023-01	0	1.9
2023-02	0	1.91
2023-03	0	2.02
2023-04	0	2.22
2023-05	0	2.08
2023-06	0	2.18
2023-07	0	2.03
2023-08	0	1.72
2023-09	0	1.52
2023-10	0	1.62
2023-11	0	1.66
2023-12	0	1.43
2024-01	0	1.61
2024-02	0	1.84
2024-03	0	1.64
2024-04	0	1.88
2024-05	0	1.6
2024-06	0	1.87
2024-07	0	1.55
2024-08	0	1.7
2024-09	0	1.67
2024-10	0	1.75
2024-11	0	1.64
2024-12	0	1.65
2025-01	0	1.71
2025-02	0	1.67
2025-03	0	1.87
2025-04	0	1.82
2025-05	0	1.84
2025-06	0	1.89
2025-07	0	1.71
2025-08	0	1.7
2025-09	0	1.46
2025-10	0	1.61
2025-11	0	1.77
2025-12	0	2.14
2026-01	0	1.85
2026-02	0	1.77
2026-03	0	1.73
2026-04	0	1.73
2026-05	0	1.68
2026-06	0	1.76

This device (reports/month)Average device in HSD, KWT, PHX (reports/device/month)

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2020-07-29	3009532798-2020-00299	Injury	Available	model number

Regulatory clearances

510(k)K192206Substantially equivalent (SESE) · 2019-10-08clearance family

Predicate lineage

K192206

Cited as predicate by: K193394

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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