U2 Total Knee System · 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.

99 linked reportsMalfunction 99

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	2.43
2019-02	0	2.31
2019-03	0	2.25
2019-04	0	2.08
2019-05	0	2.21
2019-06	0	2.28
2019-07	0	2.37
2019-08	0	2.23
2019-09	0	2.68
2019-10	0	2.1
2019-11	0	2.09
2019-12	0	2.29
2020-01	0	2.34
2020-02	0	2.07
2020-03	0	2.14
2020-04	0	2.25
2020-05	0	2.09
2020-06	0	2.65
2020-07	0	3.62
2020-08	0	3.36
2020-09	0	3.49
2020-10	0	4.02
2020-11	0	3.63
2020-12	0	3.57
2021-01	0	3.73
2021-02	0	3.67
2021-03	0	3.23
2021-04	0	3.49
2021-05	0	3.18
2021-06	0	3.03
2021-07	0	2.66
2021-08	0	3.22
2021-09	0	2.79
2021-10	0	2.52
2021-11	0	3.11
2021-12	0	2.67
2022-01	0	2.6
2022-02	0	3.13
2022-03	0	3.17
2022-04	0	3.52
2022-05	0	3.71
2022-06	0	2.82
2022-07	0	2.5
2022-08	0	2.59
2022-09	0	2.82
2022-10	0	3.08
2022-11	0	3.6
2022-12	0	3.74
2023-01	0	4.57
2023-02	0	3.11
2023-03	0	3.63
2023-04	0	3.08
2023-05	0	3.19
2023-06	0	3.19
2023-07	0	2.85
2023-08	0	2.89
2023-09	0	2.22
2023-10	0	2.4
2023-11	0	3.21
2023-12	0	3.04
2024-01	0	2.84
2024-02	22	3.03
2024-03	8	2.79
2024-04	32	3.59
2024-05	10	3.57
2024-06	4	3.68
2024-07	3	2.83
2024-08	2	2.74
2024-09	0	3.06
2024-10	4	3.11
2024-11	0	2.81
2024-12	4	2.56
2025-01	4	2.86
2025-02	0	4.24
2025-03	2	5.06
2025-04	0	2.79
2025-05	2	2.85
2025-06	0	2.78
2025-07	0	2.56
2025-08	0	2.6
2025-09	0	2.15
2025-10	0	2.32
2025-11	0	2.66
2025-12	0	3.79
2026-01	2	3.54
2026-02	0	3.48
2026-03	0	3.22
2026-04	0	3.13
2026-05	0	2.6
2026-06	0	3.35

This device (reports/month)Average device in LXH (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
2026-01-28	9681642-2026-00001	Malfunction	Available	exact di
2025-05-21	9681642-2025-00007	Malfunction	Available	exact di
2025-03-10	9681642-2025-00006	Malfunction	Available	exact di
2025-01-17	9681642-2025-00003	Malfunction	Available	exact di
2025-01-17	9681642-2025-00002	Malfunction	Available	exact di
2024-12-26	9681642-2024-00035	Malfunction	Available	exact di
2024-12-26	9681642-2024-00036	Malfunction	Available	exact di
2024-10-30	9681642-2024-00032	Malfunction	Available	exact di
2024-10-30	9681642-2024-00033	Malfunction	Available	exact di
2024-08-09	9681642-2024-00031	Malfunction	Available	exact di
2024-07-30	9681642-2024-00030	Malfunction	Available	model number
2024-07-30	9681642-2024-00028	Malfunction	Available	model number
2024-07-30	9681642-2024-00029	Malfunction	Available	model number
2024-06-07	9681642-2024-00021	Malfunction	Available	exact di
2024-06-07	9681642-2024-00020	Malfunction	Available	exact di

Showing the most recent 51 of 99 linked reports.

Showing 1–15 of 51

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-03-12	VAI	Voluntary action indicated	United Orthopedic Corp.	0
2026-03-12	VAI	Voluntary action indicated	United Orthopedic Corp.	0

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