ADVANCE® · 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.

33 linked reportsInjury 33

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	1.82
2019-02	0	1.86
2019-03	0	1.39
2019-04	0	1.52
2019-05	0	1.58
2019-06	3	1.92
2019-07	0	1.53
2019-08	0	1.52
2019-09	0	1.31
2019-10	0	1.55
2019-11	0	1.45
2019-12	0	2.26
2020-01	0	1.62
2020-02	0	1.86
2020-03	0	2.6
2020-04	0	2.1
2020-05	0	1.47
2020-06	0	3.6
2020-07	0	4.41
2020-08	0	4.34
2020-09	0	3.93
2020-10	3	4.72
2020-11	0	4.75
2020-12	3	7.34
2021-01	0	4.83
2021-02	3	5.1
2021-03	3	2.66
2021-04	0	2.48
2021-05	3	4.68
2021-06	0	4.39
2021-07	0	3.94
2021-08	0	4.34
2021-09	0	5.65
2021-10	0	3.6
2021-11	0	3.87
2021-12	0	4.32
2022-01	3	3.66
2022-02	0	5.3
2022-03	0	4.25
2022-04	0	4.26
2022-05	0	6.4
2022-06	0	3.46
2022-07	0	4.71
2022-08	0	3.46
2022-09	0	3.19
2022-10	0	4.1
2022-11	0	3.72
2022-12	0	4.11
2023-01	0	4.35
2023-02	0	3.31
2023-03	0	2.68
2023-04	6	4.15
2023-05	0	3.17
2023-06	0	3.87
2023-07	0	2.42
2023-08	0	2.5
2023-09	0	1.91
2023-10	0	2.18
2023-11	0	2.84
2023-12	0	2.07
2024-01	3	3.12
2024-02	0	2.46
2024-03	3	2.73
2024-04	0	2.94
2024-05	0	1.95
2024-06	0	2.41
2024-07	0	2.96
2024-08	0	2.81
2024-09	0	2.74
2024-10	0	2.3
2024-11	0	2.11
2024-12	0	3.03
2025-01	0	2.23
2025-02	0	2.2
2025-03	0	2.2
2025-04	0	2.32
2025-05	0	2.29
2025-06	0	1.94
2025-07	0	2.62
2025-08	0	1.88
2025-09	0	2.48
2025-10	0	2.57
2025-11	0	2
2025-12	0	2.58
2026-01	0	1.73
2026-02	0	2.29
2026-03	0	2.41
2026-04	0	2
2026-05	0	2.71
2026-06	0	1.97

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-03-21	3010536692-2024-00140	Injury	Available	catalog number
2024-01-23	3010536692-2024-00039	Injury	Available	catalog number
2023-04-12	3010536692-2023-00061	Injury	Available	catalog number
2023-04-12	3010536692-2023-00070	Injury	Available	catalog number
2022-01-31	3010536692-2022-00030	Injury	Available	catalog number
2021-05-10	3010536692-2021-00286	Injury	Available	catalog number
2021-03-03	3010536692-2021-00137	Injury	Available	catalog number
2021-02-09	3010536692-2021-00072	Injury	Available	catalog number
2020-12-07	3010536692-2020-00733	Injury	Available	catalog number
2020-10-09	3010536692-2020-00646	Injury	Available	catalog number
2019-06-25	3010536692-2019-00844	Injury	Available	catalog number

Showing the most recent 11 of 33 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-02-08	NAI	No action indicated	MicroPort Orthopedics Inc.	0
2023-02-08	NAI	No action indicated	MicroPort Orthopedics Inc.	0
2018-06-29	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	2
2018-06-29	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	2
2015-08-19	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	5
2015-08-19	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	5
2015-06-17	WL	Warning Letter	MicroPort Orthopedics Inc.	—
2015-06-17	WL	Warning Letter	MicroPort Orthopedics Inc.	—

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