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.

59 linked reportsInjury 43Malfunction 16

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	1	1.88
2019-05	0	2.1
2019-06	0	1.88
2019-07	1	1.68
2019-08	0	2.18
2019-09	0	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	3	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	1	2.1
2023-01	0	1.85
2023-02	0	2.06
2023-03	0	2.05
2023-04	0	2.22
2023-05	1	2.12
2023-06	1	2.32
2023-07	0	2.11
2023-08	3	1.76
2023-09	6	1.59
2023-10	2	1.64
2023-11	2	1.69
2023-12	0	1.46
2024-01	0	1.9
2024-02	4	1.89
2024-03	6	1.73
2024-04	0	1.87
2024-05	0	1.72
2024-06	0	1.89
2024-07	0	1.63
2024-08	2	1.73
2024-09	0	1.74
2024-10	2	1.73
2024-11	2	1.64
2024-12	0	1.67
2025-01	0	1.74
2025-02	0	1.65
2025-03	0	1.94
2025-04	0	1.73
2025-05	2	1.83
2025-06	0	1.96
2025-07	4	1.8
2025-08	0	1.61
2025-09	0	1.52
2025-10	2	1.69
2025-11	2	1.74
2025-12	0	2.19
2026-01	0	1.93
2026-02	4	1.85
2026-03	6	1.8
2026-04	2	1.74
2026-05	0	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
2026-04-30	0001649390-2026-00390	Injury	Available	catalog number
2026-03-23	0001649390-2026-00299	Malfunction	Available	catalog number
2026-03-10	0001649390-2026-00249	Injury	Available	catalog number
2026-03-10	0001649390-2026-00255	Injury	Available	catalog number
2026-02-24	0001649390-2026-00193	Injury	Available	catalog number
2026-02-10	0001649390-2026-00112	Injury	Available	catalog number
2025-11-27	0001649390-2025-00881	Injury	Available	catalog number
2025-10-20	0001649390-2025-00739	Injury	Available	catalog number
2025-07-09	0001649390-2025-00497	Injury	Available	catalog number
2025-07-09	0001649390-2025-00499	Injury	Available	catalog number
2025-05-27	0001649390-2025-00373	Injury	Available	catalog number
2024-11-14	0001649390-2024-00644	Malfunction	Available	catalog number
2024-10-22	0001649390-2024-00612	Injury	Available	catalog number
2024-08-22	0001649390-2024-00393	Injury	Available	catalog number
2024-03-23	0001649390-2024-00124	Injury	Available	catalog number

Showing the most recent 33 of 59 linked reports.

Showing 1–15 of 33

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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