1.5MM SYSTEM · 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.

53 linked reportsMalfunction 53

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	4.33
2019-02	0	8.89
2019-03	0	15.63
2019-04	0	12.56
2019-05	0	12.29
2019-06	0	12.2
2019-07	0	11.78
2019-08	0	21.4
2019-09	0	12.86
2019-10	0	15.88
2019-11	0	14.71
2019-12	0	19.43
2020-01	0	13.13
2020-02	0	13.63
2020-03	0	14
2020-04	0	9.63
2020-05	0	6.56
2020-06	0	10.17
2020-07	0	8.15
2020-08	0	8
2020-09	0	11.11
2020-10	0	8.46
2020-11	0	12
2020-12	0	12.17
2021-01	0	12.75
2021-02	0	10.11
2021-03	0	12.1
2021-04	0	10.2
2021-05	0	7.09
2021-06	0	15.33
2021-07	0	9.64
2021-08	0	9.67
2021-09	14	11.08
2021-10	0	10.11
2021-11	8	6.83
2021-12	0	13.22
2022-01	0	7.85
2022-02	0	8.38
2022-03	2	12
2022-04	0	12.22
2022-05	0	7.2
2022-06	2	12.31
2022-07	0	14.44
2022-08	0	9.57
2022-09	0	10.73
2022-10	0	7.71
2022-11	0	8.2
2022-12	0	15.55
2023-01	1	7.92
2023-02	0	9.18
2023-03	2	6.95
2023-04	2	8.75
2023-05	6	12.15
2023-06	0	11
2023-07	0	12.67
2023-08	0	9.09
2023-09	0	9.9
2023-10	0	8.36
2023-11	0	10.69
2023-12	0	6.69
2024-01	0	7.56
2024-02	0	7.4
2024-03	0	7.54
2024-04	0	9.17
2024-05	0	5.46
2024-06	0	9.64
2024-07	0	7.5
2024-08	0	7
2024-09	0	8.67
2024-10	2	7.76
2024-11	0	6.55
2024-12	0	7.25
2025-01	0	7.27
2025-02	0	7.08
2025-03	0	6.46
2025-04	0	8.09
2025-05	0	8.18
2025-06	0	9.1
2025-07	0	7.64
2025-08	0	5.93
2025-09	0	6.64
2025-10	0	5.57
2025-11	0	7.88
2025-12	0	7.69
2026-01	2	8.42
2026-02	0	6
2026-03	0	6.45
2026-04	0	8.83
2026-05	10	7.08
2026-06	2	10.43

This device (reports/month)Average device in GEY (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
2026-06-04	0001032347-2026-00150	Malfunction	Available	catalog number
2026-05-13	0001032347-2026-00109	Malfunction	Available	catalog number
2026-05-13	0001032347-2026-00111	Malfunction	Available	catalog number
2026-05-13	0001032347-2026-00112	Malfunction	Available	catalog number
2026-05-13	0001032347-2026-00113	Malfunction	Available	catalog number
2026-05-13	0001032347-2026-00110	Malfunction	Available	catalog number
2026-01-22	0001032347-2026-00018	Malfunction	Available	catalog number
2024-10-03	0001032347-2024-00306	Malfunction	Available	catalog number
2023-05-08	0001032347-2023-00158	Malfunction	Available	catalog number
2023-05-08	0001032347-2023-00159	Malfunction	Available	catalog number
2023-05-08	0001032347-2023-00160	Malfunction	Available	catalog number
2023-04-06	0001032347-2023-00122	Malfunction	Available	catalog number
2023-03-28	0001032347-2023-00099	Malfunction	Available	catalog number
2023-01-03	0001032347-2022-00406	Malfunction	Available	catalog number
2022-06-07	0001032347-2022-00192	Malfunction	Available	catalog number

Showing the most recent 34 of 53 linked reports.

Showing 1–15 of 34

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-03-04	VAI	Voluntary action indicated	Zimmer Biomet CMF and Thoracic LLC	3
2018-05-24	VAI	Voluntary action indicated	Zimmer Biomet CMF and Thoracic LLC	1
2017-09-01	VAI	Voluntary action indicated	Zimmer Biomet CMF and Thoracic LLC	3
2015-10-30	VAI	Voluntary action indicated	Zimmer Biomet CMF and Thoracic LLC	1
2012-01-17	VAI	Voluntary action indicated	Zimmer Biomet CMF and Thoracic LLC	2

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