GLOBAL AP · 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.

4 linked reportsInjury 4

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	1.71
2019-02	0	1.54
2019-03	0	1.66
2019-04	0	1.53
2019-05	0	1.78
2019-06	0	1.84
2019-07	0	1.38
2019-08	0	1.99
2019-09	0	1.51
2019-10	0	1.76
2019-11	0	1.63
2019-12	0	1.72
2020-01	0	1.95
2020-02	0	2.16
2020-03	0	1.64
2020-04	0	1.7
2020-05	0	1.51
2020-06	0	1.83
2020-07	0	1.94
2020-08	0	1.73
2020-09	0	1.95
2020-10	0	2
2020-11	0	1.83
2020-12	0	1.79
2021-01	0	1.93
2021-02	0	1.92
2021-03	0	2.02
2021-04	0	1.87
2021-05	0	1.78
2021-06	0	1.58
2021-07	0	1.92
2021-08	0	2.1
2021-09	0	1.74
2021-10	0	1.82
2021-11	0	1.99
2021-12	0	1.92
2022-01	0	2.14
2022-02	0	2.1
2022-03	0	1.77
2022-04	0	2.07
2022-05	0	1.93
2022-06	0	2.03
2022-07	0	2.15
2022-08	0	1.98
2022-09	0	1.88
2022-10	0	1.87
2022-11	0	1.93
2022-12	0	1.81
2023-01	0	1.75
2023-02	0	1.83
2023-03	0	1.96
2023-04	0	1.94
2023-05	0	2.01
2023-06	0	2.21
2023-07	0	2
2023-08	0	1.61
2023-09	0	1.44
2023-10	0	1.57
2023-11	0	1.56
2023-12	0	1.39
2024-01	0	1.81
2024-02	0	1.64
2024-03	0	1.59
2024-04	0	1.74
2024-05	0	1.59
2024-06	0	1.88
2024-07	0	1.5
2024-08	0	1.68
2024-09	0	1.61
2024-10	0	1.59
2024-11	0	1.51
2024-12	2	1.55
2025-01	0	1.67
2025-02	0	1.52
2025-03	0	1.78
2025-04	0	1.58
2025-05	2	1.66
2025-06	0	1.76
2025-07	0	1.66
2025-08	0	1.51
2025-09	0	1.48
2025-10	0	1.56
2025-11	0	1.74
2025-12	0	2.08
2026-01	0	1.81
2026-02	0	1.79
2026-03	0	1.66
2026-04	0	1.69
2026-05	0	1.65
2026-06	0	1.68

This device (reports/month)Average device in HSD, KWS (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-05-27	1818910-2025-08500	Injury	Available	catalog number
2024-12-27	1818910-2024-26112	Injury	Available	catalog number

Showing the most recent 2 of 4 linked reports.

Regulatory clearances

Predicate lineage

K060874

Cited as predicate by: K123814, K130759, K203230

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

Date	Type	Outcome	Facility	Citations
2024-03-28	NAI	No action indicated	DePuy Orthopaedics, Inc.	0
2022-05-12	NAI	No action indicated	DePuy Orthopaedics, Inc.	0
2019-11-08	NAI	No action indicated	DePuy Orthopaedics, Inc.	0
2017-09-01	VAI	Voluntary action indicated	DePuy Orthopaedics, Inc.	2
2015-10-01	VAI	Voluntary action indicated	DePuy Orthopaedics, Inc.	2
2015-09-24	NAI	No action indicated	DePuy Orthopaedics, Inc.	0
2012-11-26	VAI	Voluntary action indicated	DePuy Orthopaedics, Inc.	6
2011-12-08	WL	Warning Letter	DePuy Orthopaedics, Inc.	—
2011-08-16	NAI	No action indicated	DePuy Orthopaedics, Inc.	0
2011-06-07	OAI	Official action indicated	DePuy Orthopaedics, Inc.	6
2010-08-19	WL	Warning Letter	DePuy Orthopaedics, Inc.	—

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