Tornier Perform® Reversed Augmented Glenoid · recalls, adverse events, clearances

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.

51 linked reportsInjury 49Malfunction 2

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	1.82
2019-02	0	1.85
2019-03	0	1.75
2019-04	0	1.88
2019-05	0	2.1
2019-06	0	1.88
2019-07	0	1.68
2019-08	1	2.18
2019-09	1	1.67
2019-10	0	1.88
2019-11	0	1.72
2019-12	0	1.77
2020-01	0	1.96
2020-02	0	2.08
2020-03	0	2.19
2020-04	0	1.8
2020-05	0	1.66
2020-06	0	1.95
2020-07	0	2.24
2020-08	0	1.76
2020-09	0	1.96
2020-10	0	2.2
2020-11	0	1.9
2020-12	0	1.87
2021-01	0	2.2
2021-02	0	1.99
2021-03	0	2.15
2021-04	0	2.02
2021-05	0	2.02
2021-06	0	1.91
2021-07	0	2.06
2021-08	0	2.19
2021-09	0	1.97
2021-10	0	2.18
2021-11	0	2.13
2021-12	0	2.6
2022-01	0	2.65
2022-02	0	2.35
2022-03	0	2.51
2022-04	0	2.48
2022-05	0	2.13
2022-06	0	2.24
2022-07	1	2.2
2022-08	0	2.27
2022-09	0	2.04
2022-10	0	2.12
2022-11	0	2.16
2022-12	3	2.1
2023-01	2	1.85
2023-02	0	2.06
2023-03	0	2.05
2023-04	0	2.22
2023-05	3	2.12
2023-06	0	2.32
2023-07	0	2.11
2023-08	0	1.76
2023-09	0	1.59
2023-10	0	1.64
2023-11	0	1.69
2023-12	0	1.46
2024-01	0	1.9
2024-02	2	1.89
2024-03	2	1.73
2024-04	0	1.87
2024-05	2	1.72
2024-06	0	1.89
2024-07	0	1.63
2024-08	0	1.73
2024-09	0	1.74
2024-10	5	1.73
2024-11	2	1.64
2024-12	2	1.67
2025-01	0	1.74
2025-02	2	1.65
2025-03	0	1.94
2025-04	2	1.73
2025-05	4	1.83
2025-06	2	1.96
2025-07	2	1.8
2025-08	0	1.61
2025-09	0	1.52
2025-10	1	1.69
2025-11	0	1.74
2025-12	0	2.19
2026-01	2	1.93
2026-02	2	1.85
2026-03	2	1.8
2026-04	0	1.74
2026-05	6	1.8
2026-06	0	1.8

This device (reports/month)Average device in KWS, PHX (reports/device/month)

Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-05-29	0001649390-2026-00507	Injury	Available	catalog number
2026-05-21	0001649390-2026-00487	Injury	Available	catalog number
2026-05-20	0001649390-2026-00471	Injury	Available	catalog number
2026-03-02	0001649390-2026-00203	Injury	Available	catalog number
2026-02-02	0001649390-2026-00093	Injury	Available	catalog number
2026-01-14	0001649390-2026-00042	Injury	Available	catalog number
2025-10-28	3000931034-2025-00585	Injury	Available	exact di
2025-07-17	0001649390-2025-00522	Injury	Available	catalog number
2025-06-18	0001649390-2025-00443	Injury	Available	catalog number
2025-05-20	0001649390-2025-00329	Injury	Available	catalog number
2025-05-02	0001649390-2025-00296	Injury	Available	catalog number
2025-04-22	0001649390-2025-00273	Injury	Available	catalog number
2025-02-07	0001649390-2025-00085	Injury	Available	catalog number
2024-12-26	0001649390-2024-00731	Injury	Available	catalog number
2024-11-14	0001649390-2024-00642	Injury	Available	catalog number

Showing the most recent 27 of 51 linked reports.

Showing 1–15 of 27

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2015-07-15	NAI	No action indicated	Tornier, Inc	0
2015-01-22	NAI	No action indicated	Tornier Inc.	0
2014-03-26	NAI	No action indicated	Tornier, Inc	0
2013-01-31	VAI	Voluntary action indicated	Tornier, Inc	4
2011-11-03	NAI	No action indicated	Tornier, Inc	0

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