ACCLAIM · 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.

1 linked reportInjury 1

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	1.33
2019-02	0	1
2019-03	0	1
2019-04	0	1
2019-05	0	1
2019-06	1	1.25
2019-08	0	1
2019-10	0	1
2019-11	0	1.22
2019-12	0	1.4
2020-01	0	1.2
2020-02	0	2.5
2020-04	0	2.33
2020-05	0	1
2020-06	0	1.9
2020-07	0	1
2020-08	0	1
2020-09	0	2
2020-10	0	1.67
2020-11	0	1.23
2020-12	0	1.5
2021-01	0	1.5
2021-02	0	1.17
2021-03	0	1.17
2021-04	0	1.14
2021-05	0	3
2021-06	0	1.7
2021-07	0	1.5
2021-08	0	1.67
2021-09	0	1.67
2021-10	0	1.75
2021-11	0	1.33
2021-12	0	2.25
2022-01	0	1.44
2022-02	0	1.44
2022-03	0	2.14
2022-04	0	1.78
2022-05	0	2.29
2022-06	0	1.5
2022-07	0	1.56
2022-08	0	2.08
2022-09	0	2.17
2022-10	0	2
2022-11	0	2.19
2022-12	0	2
2023-01	0	2.5
2023-02	0	1.4
2023-03	0	2.27
2023-04	0	1.43
2023-05	0	1.54
2023-06	0	1.67
2023-07	0	1.63
2023-08	0	1.36
2023-09	0	1.22
2023-10	0	1.64
2023-11	0	1.31
2023-12	0	1.13
2024-01	0	2.21
2024-02	0	1
2024-03	0	1.53
2024-04	0	1.41
2024-05	0	1.2
2024-06	0	2.33
2024-07	0	1.39
2024-08	0	2.05
2024-09	0	3.93
2024-10	0	1.61
2024-11	0	1.58
2024-12	0	1
2025-01	0	1.21
2025-02	0	1.22
2025-03	0	1.11
2025-04	0	1.29
2025-05	0	1
2025-06	0	1.15
2025-07	0	1.21
2025-08	0	1.33
2025-09	0	1.17
2025-10	0	2.03
2025-11	0	1.87
2025-12	0	1.67
2026-01	0	1
2026-02	0	1
2026-03	0	1.33
2026-04	0	1.55
2026-05	0	1.48
2026-06	0	1

This device (reports/month)Average device in JDB, JDC (reports/device/month)

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2019-06-12	1818910-2019-95777	Injury	Available	exact di

Regulatory clearances

None linked.

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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