PROFEMUR® · 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.

39 linked reportsInjury 39

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	3.06
2019-02	0	2.61
2019-03	0	3.01
2019-04	0	2.79
2019-05	1	2.19
2019-06	0	1.88
2019-07	0	1.85
2019-08	0	2.22
2019-09	1	2.45
2019-10	1	2.72
2019-11	0	2.29
2019-12	0	2.59
2020-01	1	3
2020-02	0	2.64
2020-03	2	3.36
2020-04	1	2.37
2020-05	0	2.26
2020-06	0	2.21
2020-07	4	2.68
2020-08	0	2.11
2020-09	1	2.68
2020-10	1	2.69
2020-11	0	2.44
2020-12	0	2.48
2021-01	0	2.61
2021-02	1	2.18
2021-03	1	2.18
2021-04	0	2.2
2021-05	1	2.07
2021-06	1	2.65
2021-07	0	2.54
2021-08	1	2.55
2021-09	0	2.63
2021-10	0	2.38
2021-11	0	2.18
2021-12	0	2.48
2022-01	3	2.23
2022-02	0	2.14
2022-03	0	2.4
2022-04	1	2.25
2022-05	2	2.29
2022-06	1	2.4
2022-07	0	2.25
2022-08	0	2.33
2022-09	0	2.37
2022-10	0	2.31
2022-11	1	2.4
2022-12	0	2.39
2023-01	0	2.55
2023-02	0	2.36
2023-03	0	2.61
2023-04	0	2.47
2023-05	0	2.36
2023-06	2	2.44
2023-07	0	2.32
2023-08	0	2.13
2023-09	1	2.11
2023-10	2	1.82
2023-11	1	1.77
2023-12	0	1.89
2024-01	0	1.87
2024-02	1	2.2
2024-03	0	2.08
2024-04	1	1.92
2024-05	0	2.27
2024-06	1	2.08
2024-07	0	1.85
2024-08	0	2.06
2024-09	0	2.22
2024-10	1	1.93
2024-11	0	1.92
2024-12	0	1.68
2025-01	0	2.08
2025-02	1	1.62
2025-03	1	1.84
2025-04	0	1.9
2025-05	0	1.86
2025-06	0	1.92
2025-07	0	1.93
2025-08	0	1.85
2025-09	0	1.79
2025-10	0	1.81
2025-11	0	1.82
2025-12	0	1.94
2026-01	0	2.01
2026-02	1	1.75
2026-03	0	1.97
2026-04	0	1.94
2026-05	0	1.79
2026-06	0	1.85

This device (reports/month)Average device in LPH, LWJ, LZO, MBL (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-02-11	3010536692-2026-00016	Injury	Available	exact di
2025-03-07	3010536692-2025-00067	Injury	Available	exact di
2025-02-05	3010536692-2025-00025	Injury	Available	exact di
2024-10-03	3010536692-2024-00453	Injury	Available	exact di
2024-06-18	3010536692-2024-00347	Injury	Available	exact di
2024-04-29	3010536692-2024-00278	Injury	Available	exact di
2024-02-01	3010536692-2024-00070	Injury	Available	exact di
2023-11-07	3010536692-2023-00200	Injury	Available	exact di
2023-10-18	3010536692-2023-00185	Injury	Available	exact di
2023-10-18	3010536692-2023-00186	Injury	Available	exact di
2023-09-18	3010536692-2023-00166	Injury	Available	exact di
2023-06-02	3010536692-2023-00107	Injury	Available	exact di
2023-06-01	3010536692-2023-00103	Injury	Available	exact di
2022-11-25	3010536692-2022-00420	Injury	Available	exact di
2022-06-27	3010536692-2022-00237	Injury	Available	exact di

Showing the most recent 37 of 39 linked reports.

Showing 1–15 of 37

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