Dynasty · 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.

57 linked reportsInjury 57

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	3.45
2019-02	0	2.83
2019-03	0	3.19
2019-04	0	2.99
2019-05	0	2.34
2019-06	0	1.97
2019-07	3	2.05
2019-08	0	2.24
2019-09	3	2.68
2019-10	0	2.85
2019-11	0	2.32
2019-12	0	2.65
2020-01	3	3.01
2020-02	0	2.73
2020-03	3	3.55
2020-04	0	2.39
2020-05	0	2.4
2020-06	0	2.21
2020-07	3	2.72
2020-08	0	2.09
2020-09	0	2.64
2020-10	3	2.7
2020-11	0	2.45
2020-12	0	2.46
2021-01	0	2.63
2021-02	0	2.15
2021-03	6	2.17
2021-04	0	2.17
2021-05	0	2.08
2021-06	0	2.71
2021-07	0	2.46
2021-08	6	2.38
2021-09	3	2.45
2021-10	0	2.26
2021-11	0	2.22
2021-12	3	2.52
2022-01	0	2.16
2022-02	0	2.21
2022-03	0	2.29
2022-04	3	2.27
2022-05	0	2.12
2022-06	0	2.39
2022-07	0	2.16
2022-08	0	2.26
2022-09	0	2.22
2022-10	0	2.21
2022-11	0	2.31
2022-12	0	2.33
2023-01	0	2.23
2023-02	3	2.26
2023-03	0	2.55
2023-04	0	2.32
2023-05	0	2.31
2023-06	3	2.35
2023-07	0	2.19
2023-08	0	2.1
2023-09	3	2.07
2023-10	0	1.72
2023-11	0	1.67
2023-12	0	1.78
2024-01	0	1.79
2024-02	3	2.09
2024-03	0	2
2024-04	0	1.79
2024-05	0	2.13
2024-06	0	1.98
2024-07	0	1.79
2024-08	3	1.9
2024-09	3	2.15
2024-10	0	1.84
2024-11	0	1.76
2024-12	0	1.58
2025-01	0	1.91
2025-02	0	1.52
2025-03	0	1.76
2025-04	0	1.82
2025-05	0	1.7
2025-06	0	1.84
2025-07	0	1.84
2025-08	0	1.7
2025-09	0	1.84
2025-10	0	1.76
2025-11	0	1.84
2025-12	0	1.93
2026-01	0	2.03
2026-02	0	1.64
2026-03	0	2.04
2026-04	0	1.86
2026-05	0	1.74
2026-06	0	1.77

This device (reports/month)Average device in JDI, LPH, MBL (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
2024-09-26	3010536692-2024-00440	Injury	Available	catalog number
2024-08-22	3010536692-2024-00421	Injury	Available	catalog number
2024-02-12	3010536692-2024-00079	Injury	Available	catalog number
2023-09-29	3010536692-2023-00173	Injury	Available	catalog number
2023-06-12	3010536692-2023-00115	Injury	Available	catalog number
2023-02-15	3010536692-2023-00023	Injury	Available	catalog number
2022-04-27	3010536692-2022-00144	Injury	Available	catalog number
2021-12-29	3010536692-2021-00602	Injury	Available	catalog number
2021-09-23	3010536692-2021-00526	Injury	Available	catalog number
2021-08-30	3010536692-2021-00455	Injury	Available	catalog number
2021-08-30	3010536692-2021-00473	Injury	Available	catalog number
2021-03-30	3010536692-2021-00186	Injury	Available	catalog number
2021-03-02	3010536692-2021-00118	Injury	Available	catalog number
2020-10-28	3010536692-2020-00667	Injury	Available	catalog number
2020-07-29	3010536692-2020-00532	Injury	Available	catalog number

Showing the most recent 19 of 57 linked reports.

Showing 1–15 of 19

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.	—

Similar devices