Restoration ADM/MDM X3 Insert · 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.

46 linked reportsInjury 46

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	2.72
2019-02	0	2.35
2019-03	0	2.65
2019-04	0	2.54
2019-05	0	2.03
2019-06	0	1.73
2019-07	0	1.74
2019-08	0	2.02
2019-09	0	2.16
2019-10	0	2.35
2019-11	0	1.99
2019-12	0	2.25
2020-01	0	2.56
2020-02	0	2.32
2020-03	0	2.91
2020-04	0	2.08
2020-05	0	2.04
2020-06	0	1.91
2020-07	0	2.34
2020-08	0	1.87
2020-09	0	2.3
2020-10	0	2.28
2020-11	0	2.12
2020-12	0	2.16
2021-01	0	2.26
2021-02	0	1.9
2021-03	0	1.91
2021-04	0	1.91
2021-05	0	1.86
2021-06	0	2.31
2021-07	0	2.15
2021-08	0	2.1
2021-09	0	2.23
2021-10	0	2.06
2021-11	0	1.91
2021-12	0	2.12
2022-01	0	1.91
2022-02	0	1.94
2022-03	0	1.99
2022-04	0	2.01
2022-05	0	2
2022-06	0	2.06
2022-07	0	1.95
2022-08	0	2.02
2022-09	0	2.05
2022-10	0	2
2022-11	0	2.08
2022-12	1	1.99
2023-01	0	2.13
2023-02	0	1.97
2023-03	0	2.15
2023-04	0	2.11
2023-05	0	2.05
2023-06	1	2.11
2023-07	0	2.02
2023-08	2	1.9
2023-09	0	1.92
2023-10	0	1.6
2023-11	0	1.56
2023-12	0	1.65
2024-01	2	1.68
2024-02	1	1.95
2024-03	25	1.92
2024-04	0	1.71
2024-05	0	2.03
2024-06	1	1.87
2024-07	0	1.68
2024-08	0	1.86
2024-09	2	1.95
2024-10	1	1.74
2024-11	1	1.65
2024-12	0	1.53
2025-01	0	1.81
2025-02	0	1.48
2025-03	2	1.76
2025-04	2	1.77
2025-05	1	1.63
2025-06	0	1.78
2025-07	1	1.78
2025-08	0	1.62
2025-09	0	1.67
2025-10	0	1.68
2025-11	1	1.73
2025-12	1	1.81
2026-01	0	1.9
2026-02	0	1.58
2026-03	0	1.88
2026-04	1	1.81
2026-05	0	1.61
2026-06	0	1.69

This device (reports/month)Average device in JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MEH (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
2026-04-22	0002249697-2026-00331	Injury	Available	exact di
2025-12-03	0002249697-2025-01403	Injury	Available	exact di
2025-11-11	0002249697-2025-01315	Injury	Available	exact di
2025-07-08	0002249697-2025-00667	Injury	Available	exact di
2025-05-28	0002249697-2025-00556	Injury	Available	exact di
2025-04-24	0002249697-2025-00438	Injury	Available	exact di
2025-04-23	0002249697-2025-00434	Injury	Available	exact di
2025-03-19	0002249697-2025-00311	Injury	Available	exact di
2025-03-07	0002249697-2025-00286	Injury	Available	exact di
2024-11-21	0002249697-2024-01609	Injury	Available	exact di
2024-10-15	0002249697-2024-01418	Injury	Available	exact di
2024-09-16	0002249697-2024-01285	Injury	Available	exact di
2024-09-10	0002249697-2024-01249	Injury	Available	exact di
2024-06-29	0002249697-2024-00928	Injury	Available	exact di
2024-03-15	0002249697-2024-00425	Injury	Available	exact di

Showing 1–15 of 46

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-12-01	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	1
2021-06-22	NAI	No action indicated	Howmedica Osteonics Corp.	0
2015-03-09	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	3
2013-04-16	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	3
2010-01-15	NAI	No action indicated	Howmedica Osteonics Corp.	0

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