Tornier Perform · 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.

105 linked reportsMalfunction 105

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	8.04
2019-02	0	10.7
2019-03	0	9
2019-04	0	6.8
2019-05	0	5.96
2019-06	0	6.11
2019-07	0	7.09
2019-08	0	6.59
2019-09	0	5.29
2019-10	0	8.2
2019-11	0	7.87
2019-12	0	7.83
2020-01	0	9.32
2020-02	0	5.8
2020-03	0	7.52
2020-04	0	3.87
2020-05	0	3.5
2020-06	0	5.84
2020-07	0	7.81
2020-08	0	7.86
2020-09	0	5.17
2020-10	0	8.95
2020-11	0	4.21
2020-12	0	8.39
2021-01	0	6.96
2021-02	0	5.95
2021-03	0	7.27
2021-04	0	6.14
2021-05	0	8.33
2021-06	0	7.67
2021-07	0	6.87
2021-08	0	6.42
2021-09	0	8.69
2021-10	0	7.78
2021-11	0	8.14
2021-12	0	6.94
2022-01	0	7.29
2022-02	0	4.93
2022-03	0	6.89
2022-04	0	7.73
2022-05	0	5.97
2022-06	2	6.34
2022-07	0	7.3
2022-08	0	6.86
2022-09	0	5.8
2022-10	3	6.3
2022-11	0	7.67
2022-12	0	9
2023-01	0	9.32
2023-02	0	7.11
2023-03	0	7.28
2023-04	0	6.58
2023-05	3	6.32
2023-06	0	5.81
2023-07	0	7.59
2023-08	0	5.71
2023-09	0	4.29
2023-10	14	6.9
2023-11	2	6.06
2023-12	2	4.94
2024-01	0	6.59
2024-02	0	7.17
2024-03	0	4.73
2024-04	3	5.58
2024-05	4	5.3
2024-06	0	5
2024-07	0	4.68
2024-08	3	5.25
2024-09	7	5.16
2024-10	4	6.49
2024-11	0	5.26
2024-12	9	5.42
2025-01	3	6.08
2025-02	1	4.36
2025-03	10	4.71
2025-04	4	4.73
2025-05	2	5.52
2025-06	3	5.73
2025-07	2	6.5
2025-08	8	5.55
2025-09	5	4.73
2025-10	4	4.49
2025-11	2	5.7
2025-12	0	6.43
2026-01	2	5.54
2026-02	0	5.05
2026-03	0	5.37
2026-04	1	6.24
2026-05	0	5.06
2026-06	2	5.5

This device (reports/month)Average device in HWA (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
2026-06-25	0001649390-2026-00682	Malfunction	—	catalog number
2026-04-06	0001649390-2026-00328	Malfunction	Available	catalog number
2026-01-13	0001649390-2026-00035	Malfunction	Available	catalog number
2026-01-08	0001649390-2026-00023	Malfunction	Available	catalog number
2025-11-24	0001649390-2025-00844	Malfunction	Available	catalog number
2025-10-28	0001649390-2025-00770	Malfunction	Available	catalog number
2025-10-08	0001649390-2025-00695	Malfunction	Available	catalog number
2025-09-11	0001649390-2025-00655	Malfunction	Available	catalog number
2025-09-11	0001649390-2025-00656	Malfunction	Available	catalog number
2025-09-10	0001649390-2025-00646	Malfunction	Available	catalog number
2025-08-27	0001649390-2025-00600	Malfunction	Available	catalog number
2025-08-14	0001649390-2025-00573	Malfunction	Available	catalog number
2025-08-14	0001649390-2025-00572	Malfunction	Available	catalog number
2025-08-12	0001649390-2025-00553	Malfunction	Available	catalog number
2025-07-10	0001649390-2025-00506	Malfunction	Available	catalog number

Showing the most recent 58 of 105 linked reports.

Showing 1–15 of 58

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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