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.

41 linked reportsInjury 41

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	2.03
2019-02	0	2.07
2019-03	0	1.68
2019-04	0	2.01
2019-05	0	1.83
2019-06	0	2.19
2019-07	0	2.04
2019-08	4	2.24
2019-09	0	2.01
2019-10	3	2.44
2019-11	0	3.01
2019-12	3	2.42
2020-01	3	2.39
2020-02	0	2.82
2020-03	0	2.28
2020-04	0	2.21
2020-05	0	1.83
2020-06	6	2.09
2020-07	0	2.66
2020-08	0	2.72
2020-09	0	2.23
2020-10	3	2.94
2020-11	0	2.86
2020-12	0	2.95
2021-01	0	2.47
2021-02	0	2.45
2021-03	0	2.59
2021-04	0	2.45
2021-05	3	2.36
2021-06	3	2.18
2021-07	0	2.24
2021-08	0	1.88
2021-09	0	2.33
2021-10	0	1.96
2021-11	0	2.31
2021-12	0	2.33
2022-01	0	2.03
2022-02	0	2.38
2022-03	0	2.05
2022-04	0	2.1
2022-05	0	2.33
2022-06	3	2.03
2022-07	0	2.06
2022-08	0	2.1
2022-09	0	2.28
2022-10	0	2.2
2022-11	0	2.24
2022-12	0	1.9
2023-01	0	2.09
2023-02	0	2.23
2023-03	0	2.23
2023-04	0	2.26
2023-05	3	2.41
2023-06	0	2.26
2023-07	0	2
2023-08	0	1.71
2023-09	0	1.76
2023-10	0	1.63
2023-11	0	1.68
2023-12	0	1.7
2024-01	0	1.57
2024-02	0	1.74
2024-03	0	1.78
2024-04	0	1.64
2024-05	0	1.91
2024-06	0	1.98
2024-07	0	1.85
2024-08	0	2.31
2024-09	0	2
2024-10	0	1.99
2024-11	0	2
2024-12	0	2.09
2025-01	0	2.32
2025-02	0	1.83
2025-03	0	1.86
2025-04	0	1.66
2025-05	0	1.71
2025-06	0	1.81
2025-07	0	1.62
2025-08	0	1.63
2025-09	2	1.64
2025-10	0	1.43
2025-11	0	1.7
2025-12	0	1.66
2026-01	0	1.55
2026-02	0	1.53
2026-03	0	1.99
2026-04	0	1.75
2026-05	0	1.71
2026-06	5	1.7

This device (reports/month)Average device in JWH (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
2026-06-24	3010536692-2026-00230	Injury	Available	catalog number
2026-06-16	3010536692-2026-00218	Injury	Available	catalog number
2025-09-16	3010536692-2025-00330	Injury	Available	catalog number
2023-05-16	3010536692-2023-00094	Injury	Available	catalog number
2022-06-20	3010536692-2022-00229	Injury	Available	catalog number
2021-06-24	3010536692-2021-00338	Injury	Available	catalog number
2021-05-13	3010536692-2021-00301	Injury	Available	catalog number
2020-10-28	3010536692-2020-00664	Injury	Available	catalog number
2020-06-29	3010536692-2020-00443	Injury	Available	catalog number
2020-06-26	3010536692-2020-00429	Injury	Available	catalog number
2020-01-10	3010536692-2020-00032	Injury	Available	catalog number
2019-12-04	3010536692-2019-01163	Injury	Available	catalog number
2019-10-04	3010536692-2019-01080	Injury	Available	catalog number
2019-08-22	3010536692-2019-01010	Injury	Available	exact di
2019-08-06	3010536692-2019-00998	Injury	Available	catalog number

Showing the most recent 15 of 41 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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