Active Articulation Hip 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.

15 linked reportsInjury 15

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	3.05
2019-02	0	2.66
2019-03	0	3.06
2019-04	0	2.86
2019-05	0	2.21
2019-06	0	1.9
2019-07	0	1.87
2019-08	0	2.21
2019-09	0	2.46
2019-10	0	2.72
2019-11	0	2.27
2019-12	0	2.6
2020-01	0	3.01
2020-02	0	2.58
2020-03	0	3.26
2020-04	1	2.33
2020-05	0	2.25
2020-06	0	2.15
2020-07	0	2.55
2020-08	0	2.1
2020-09	0	2.7
2020-10	0	2.61
2020-11	0	2.42
2020-12	0	2.43
2021-01	0	2.59
2021-02	0	2.13
2021-03	0	2.12
2021-04	0	2.15
2021-05	1	2.05
2021-06	1	2.56
2021-07	1	2.42
2021-08	0	2.45
2021-09	0	2.52
2021-10	0	2.28
2021-11	0	2.14
2021-12	1	2.39
2022-01	0	2.18
2022-02	0	2.04
2022-03	1	2.29
2022-04	0	2.2
2022-05	0	2.22
2022-06	0	2.34
2022-07	1	2.16
2022-08	0	2.22
2022-09	0	2.27
2022-10	1	2.21
2022-11	0	2.27
2022-12	0	2.3
2023-01	1	2.46
2023-02	0	2.22
2023-03	0	2.47
2023-04	0	2.35
2023-05	0	2.23
2023-06	1	2.28
2023-07	0	2.11
2023-08	1	1.94
2023-09	0	1.93
2023-10	0	1.71
2023-11	1	1.65
2023-12	0	1.77
2024-01	0	1.79
2024-02	0	2.09
2024-03	0	1.93
2024-04	0	1.78
2024-05	0	2
2024-06	0	1.88
2024-07	1	1.73
2024-08	0	1.86
2024-09	0	2
2024-10	1	1.81
2024-11	0	1.84
2024-12	0	1.59
2025-01	0	2.01
2025-02	0	1.56
2025-03	0	1.83
2025-04	0	1.84
2025-05	0	1.78
2025-06	0	1.87
2025-07	0	1.86
2025-08	0	1.76
2025-09	0	1.73
2025-10	0	1.75
2025-11	0	1.8
2025-12	0	1.92
2026-01	0	1.96
2026-02	0	1.66
2026-03	0	1.9
2026-04	0	1.94
2026-05	1	1.68
2026-06	0	1.73

This device (reports/month)Average device in KWY, LPH, LZO, OQG (reports/device/month)

Failure-mode summaryAI-generated

15 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-05-04	0001825034-2026-01190	Injury	Available	exact di
2024-10-16	0001825034-2024-02456	Injury	Available	exact di
2024-07-18	0001825034-2024-01870	Injury	Available	exact di
2023-11-29	0001825034-2023-02759	Injury	Available	exact di
2023-08-08	0001825034-2023-01836	Injury	Available	exact di
2023-06-27	0001825034-2023-01420	Injury	Available	exact di
2023-01-25	0001825034-2023-00153	Injury	Available	exact di
2022-10-25	0001825034-2022-02419	Injury	Available	exact di
2022-07-12	0001825034-2022-01578	Injury	Available	exact di
2022-03-29	0001825034-2022-00703	Injury	Available	exact di
2021-12-28	0001825034-2021-03464	Injury	Available	exact di
2021-07-01	0001825034-2021-01951	Injury	Available	exact di
2021-06-23	0001825034-2021-01860	Injury	Available	exact di
2021-05-17	0001825034-2021-01490	Injury	Available	exact di
2020-04-21	0001825034-2020-01755	Injury	Available	exact di

Regulatory clearances

Predicate lineage

K101336

Cited as predicate by: K110555, K111981, K150522, K161190, K190890

K110555

Cited as predicate by: K111863, K150522, K161190

K161190

Cited as predicate by: K181491, K190656, K200011, K233724, K243456

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

None in the loaded window.

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