Tornier Perform® Reversed 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.

33 linked reportsInjury 33

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	0	1.67
2019-10	0	1.88
2019-11	1	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	1	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	3	2.16
2022-12	0	2.1
2023-01	0	1.85
2023-02	0	2.06
2023-03	0	2.05
2023-04	0	2.22
2023-05	0	2.12
2023-06	0	2.32
2023-07	0	2.11
2023-08	2	1.76
2023-09	2	1.59
2023-10	0	1.64
2023-11	0	1.69
2023-12	0	1.46
2024-01	2	1.9
2024-02	4	1.89
2024-03	2	1.73
2024-04	0	1.87
2024-05	0	1.72
2024-06	0	1.89
2024-07	1	1.63
2024-08	0	1.73
2024-09	2	1.74
2024-10	0	1.73
2024-11	2	1.64
2024-12	0	1.67
2025-01	0	1.74
2025-02	0	1.65
2025-03	1	1.94
2025-04	0	1.73
2025-05	2	1.83
2025-06	0	1.96
2025-07	0	1.8
2025-08	0	1.61
2025-09	0	1.52
2025-10	1	1.69
2025-11	0	1.74
2025-12	2	2.19
2026-01	0	1.93
2026-02	2	1.85
2026-03	0	1.8
2026-04	0	1.74
2026-05	2	1.8
2026-06	0	1.8

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

Failure-mode summaryAI-generated

33 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	0001649390-2026-00462	Injury	Available	catalog number
2026-02-16	0001649390-2026-00137	Injury	Available	catalog number
2025-12-10	0001649390-2025-00932	Injury	Available	catalog number
2025-10-20	0001649390-2025-00735	Injury	Available	catalog number
2025-05-26	0001649390-2025-00361	Injury	Available	catalog number
2025-03-12	0001649390-2025-00143	Injury	Available	catalog number
2024-11-28	0001649390-2024-00683	Injury	Available	catalog number
2024-09-05	0001649390-2024-00476	Injury	Available	catalog number
2024-07-18	0001649390-2024-00328	Injury	Available	exact di
2024-03-22	0001649390-2024-00121	Injury	Available	catalog number
2024-02-29	0001649390-2024-00070	Injury	Available	catalog number
2024-02-26	0001649390-2024-00067	Injury	Available	catalog number
2024-01-30	0001649390-2024-00022	Injury	Available	catalog number
2023-09-06	0001649390-2023-00219	Injury	Available	catalog number
2023-08-23	0001649390-2023-00205	Injury	Available	catalog number

Showing the most recent 19 of 33 linked reports.

Showing 1–15 of 19

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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