U2 Femoral component, CR, porous coated · 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.

3 linked reportsInjury 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	0	1.18
2019-02	0	1.28
2019-03	0	1.31
2019-04	0	1.37
2019-05	0	1.34
2019-06	0	1.31
2019-07	0	1.49
2019-08	0	1.27
2019-09	0	1.32
2019-10	0	1.17
2019-11	0	1.4
2019-12	0	1.33
2020-01	0	1.37
2020-02	0	1.2
2020-03	0	1.42
2020-04	0	1.24
2020-05	0	1.07
2020-06	0	1.38
2020-07	0	1.49
2020-08	0	1.3
2020-09	0	1.35
2020-10	0	1.28
2020-11	0	1.33
2020-12	0	1.19
2021-01	0	1.28
2021-02	0	1.4
2021-03	0	1.45
2021-04	0	1.3
2021-05	0	1.21
2021-06	0	1.35
2021-07	0	1.28
2021-08	0	1.33
2021-09	0	1.27
2021-10	0	1.27
2021-11	0	1.29
2021-12	0	1.35
2022-01	0	1.23
2022-02	0	1.53
2022-03	0	1.34
2022-04	0	1.32
2022-05	0	1.2
2022-06	0	1.32
2022-07	0	1.28
2022-08	0	1.3
2022-09	0	1.27
2022-10	0	1.23
2022-11	0	1.33
2022-12	0	1.27
2023-01	0	1.11
2023-02	0	1.24
2023-03	0	1.19
2023-04	0	1.38
2023-05	0	1.36
2023-06	0	1.4
2023-07	0	1.13
2023-08	0	1.13
2023-09	0	1.11
2023-10	0	1.1
2023-11	0	1.22
2023-12	0	1.17
2024-01	0	1.14
2024-02	0	1.18
2024-03	0	1.29
2024-04	0	1.27
2024-05	0	1.14
2024-06	0	1.24
2024-07	0	1.17
2024-08	0	1.32
2024-09	0	1.3
2024-10	0	1.33
2024-11	0	1.15
2024-12	0	1.22
2025-01	0	1.29
2025-02	0	1.24
2025-03	0	1.11
2025-04	0	1.26
2025-05	0	1.29
2025-06	0	1.27
2025-07	0	1.23
2025-08	0	1.35
2025-09	0	1.16
2025-10	0	1.24
2025-11	0	1.27
2025-12	0	1.35
2026-01	0	1.32
2026-02	0	1.27
2026-03	0	1.26
2026-04	0	1.25
2026-05	1	1.23
2026-06	2	1.26

This device (reports/month)Average device in MBH (reports/device/month)

Failure-mode summaryAI-generated

3 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	9681642-2026-00028	Injury	Available	catalog number
2026-05-21	9681642-2026-00024	Injury	Available	exact di

Showing the most recent 2 of 3 linked reports.

Regulatory clearances

Predicate lineage

K140075
- K030612

Cited as predicate by: K150832, K152430, K221705, K243656

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

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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