Triathlon · 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.

48 linked reportsInjury 45Malfunction 3

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	2	1.9
2019-02	0	1.96
2019-03	2	1.62
2019-04	3	1.9
2019-05	6	1.74
2019-06	3	2.03
2019-07	4	1.94
2019-08	1	2.11
2019-09	3	1.86
2019-10	2	2.21
2019-11	0	2.73
2019-12	1	2.22
2020-01	0	2.22
2020-02	0	2.55
2020-03	0	2.11
2020-04	0	2.02
2020-05	0	1.71
2020-06	2	1.96
2020-07	0	2.49
2020-08	1	2.54
2020-09	1	2.1
2020-10	1	2.65
2020-11	1	2.59
2020-12	1	2.69
2021-01	0	2.25
2021-02	0	2.24
2021-03	0	2.39
2021-04	0	2.21
2021-05	1	2.16
2021-06	0	2.05
2021-07	0	2.04
2021-08	0	1.75
2021-09	3	2.13
2021-10	0	1.81
2021-11	0	2.1
2021-12	0	2.16
2022-01	0	1.87
2022-02	0	2.2
2022-03	0	1.87
2022-04	0	1.93
2022-05	0	2.11
2022-06	1	1.87
2022-07	0	1.92
2022-08	0	1.94
2022-09	0	2.07
2022-10	0	2.04
2022-11	0	2.1
2022-12	0	1.77
2023-01	0	1.92
2023-02	0	2.05
2023-03	0	2.04
2023-04	0	2.1
2023-05	0	2.22
2023-06	1	2.1
2023-07	3	1.87
2023-08	0	1.59
2023-09	0	1.64
2023-10	0	1.53
2023-11	0	1.59
2023-12	0	1.59
2024-01	0	1.47
2024-02	0	1.63
2024-03	1	1.68
2024-04	0	1.56
2024-05	0	1.76
2024-06	0	1.84
2024-07	0	1.7
2024-08	0	2.16
2024-09	1	1.85
2024-10	0	1.85
2024-11	1	1.81
2024-12	0	1.92
2025-01	0	2.12
2025-02	0	1.71
2025-03	0	1.69
2025-04	0	1.56
2025-05	0	1.61
2025-06	0	1.68
2025-07	0	1.53
2025-08	0	1.56
2025-09	0	1.53
2025-10	1	1.38
2025-11	0	1.58
2025-12	0	1.57
2026-01	1	1.47
2026-02	0	1.46
2026-03	0	1.81
2026-04	0	1.62
2026-05	0	1.59
2026-06	0	1.57

This device (reports/month)Average device in JWH, MBH (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
2026-01-21	0002249697-2026-00045	Injury	Available	exact di
2025-10-01	0002249697-2025-01050	Injury	Available	exact di
2024-11-22	0002249697-2024-01617	Injury	Available	exact di
2024-09-23	0002249697-2024-01319	Injury	Available	exact di
2024-03-12	0002249697-2024-00383	Injury	Available	exact di
2023-07-12	0002249697-2023-00766	Injury	Available	exact di
2023-07-06	0002249697-2023-00749	Injury	Available	exact di
2023-07-05	0002249697-2023-00746	Injury	Available	exact di
2023-06-26	0002249697-2023-00714	Injury	Available	exact di
2022-06-15	0002249697-2022-00845	Injury	Available	exact di
2021-09-21	0002249697-2021-01597	Injury	Available	exact di
2021-09-16	0002249697-2021-01564	Injury	Available	exact di
2021-09-11	0002249697-2021-01545	Injury	Available	exact di
2021-05-13	0002249697-2021-00843	Injury	Available	exact di
2020-12-21	0002249697-2020-02734	Injury	Available	exact di

Showing 1–15 of 48

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-12-01	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	1
2021-06-22	NAI	No action indicated	Howmedica Osteonics Corp.	0
2015-03-09	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	3
2013-04-16	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	3
2010-01-15	NAI	No action indicated	Howmedica Osteonics Corp.	0

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