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.

112 linked reportsInjury 97Malfunction 15

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	1	1.75
2019-04	0	1.88
2019-05	0	2.1
2019-06	2	1.88
2019-07	0	1.68
2019-08	0	2.18
2019-09	1	1.67
2019-10	1	1.88
2019-11	0	1.72
2019-12	0	1.77
2020-01	1	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	2	1.99
2021-03	1	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	0	2.2
2022-08	0	2.27
2022-09	0	2.04
2022-10	0	2.12
2022-11	0	2.16
2022-12	0	2.1
2023-01	3	1.85
2023-02	0	2.06
2023-03	0	2.05
2023-04	4	2.22
2023-05	6	2.12
2023-06	1	2.32
2023-07	0	2.11
2023-08	0	1.76
2023-09	0	1.59
2023-10	2	1.64
2023-11	0	1.69
2023-12	2	1.46
2024-01	2	1.9
2024-02	2	1.89
2024-03	10	1.73
2024-04	0	1.87
2024-05	0	1.72
2024-06	0	1.89
2024-07	2	1.63
2024-08	0	1.73
2024-09	4	1.74
2024-10	2	1.73
2024-11	4	1.64
2024-12	4	1.67
2025-01	4	1.74
2025-02	0	1.65
2025-03	4	1.94
2025-04	8	1.73
2025-05	10	1.83
2025-06	6	1.96
2025-07	2	1.8
2025-08	0	1.61
2025-09	1	1.52
2025-10	4	1.69
2025-11	2	1.74
2025-12	0	2.19
2026-01	2	1.93
2026-02	4	1.85
2026-03	1	1.8
2026-04	3	1.74
2026-05	4	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
2026-05-20	0001649390-2026-00459	Injury	Available	catalog number
2026-05-18	0001649390-2026-00443	Injury	Available	catalog number
2026-04-23	0001649390-2026-00374	Injury	Available	catalog number
2026-04-02	0001649390-2026-00325	Injury	Available	catalog number
2026-03-23	0001649390-2026-00298	Injury	Available	catalog number
2026-02-23	0001649390-2026-00179	Injury	Available	catalog number
2026-02-12	0001649390-2026-00129	Injury	Available	catalog number
2026-01-05	0001649390-2026-00008	Injury	Available	catalog number
2025-11-13	0001649390-2025-00821	Injury	Available	catalog number
2025-10-30	0001649390-2025-00775	Injury	Available	catalog number
2025-10-09	0001649390-2025-00697	Injury	Available	catalog number
2025-09-23	3000931034-2025-00509	Injury	Available	exact di
2025-07-01	0001649390-2025-00479	Injury	Available	catalog number
2025-06-25	0001649390-2025-00466	Injury	Available	catalog number
2025-06-10	0001649390-2025-00396	Injury	Available	catalog number

Showing the most recent 63 of 112 linked reports.

Showing 1–15 of 63

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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