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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.

11 linked reportsMalfunction 9Injury 2
12342019-01: 0 reports for this device; peer average 1.83/device2019-02: 0 reports for this device; peer average 1.51/device2019-03: 0 reports for this device; peer average 2.02/device2019-04: 0 reports for this device; peer average 2.43/device2019-05: 0 reports for this device; peer average 1.89/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 1.69/device2019-08: 0 reports for this device; peer average 1.57/device2019-09: 0 reports for this device; peer average 1.68/device2019-10: 0 reports for this device; peer average 1.66/device2019-11: 0 reports for this device; peer average 1.7/device2019-12: 0 reports for this device; peer average 2.05/device2020-01: 0 reports for this device; peer average 2.19/device2020-02: 0 reports for this device; peer average 1.31/device2020-03: 0 reports for this device; peer average 1.69/device2020-04: 0 reports for this device; peer average 1.95/device2020-05: 0 reports for this device; peer average 1.82/device2020-06: 0 reports for this device; peer average 1.9/device2020-07: 0 reports for this device; peer average 1.95/device2020-08: 0 reports for this device; peer average 2.28/device2020-09: 2 reports for this device; peer average 2.62/device2020-10: 0 reports for this device; peer average 1.97/device2020-11: 0 reports for this device; peer average 2.08/device2020-12: 0 reports for this device; peer average 2.17/device2021-01: 0 reports for this device; peer average 1.81/device2021-02: 0 reports for this device; peer average 1.78/device2021-03: 0 reports for this device; peer average 2.06/device2021-04: 0 reports for this device; peer average 2.72/device2021-05: 0 reports for this device; peer average 2.73/device2021-06: 0 reports for this device; peer average 1.99/device2021-07: 0 reports for this device; peer average 2.14/device2021-08: 0 reports for this device; peer average 2.01/device2021-09: 0 reports for this device; peer average 1.92/device2021-10: 0 reports for this device; peer average 2.01/device2021-11: 0 reports for this device; peer average 2.03/device2021-12: 0 reports for this device; peer average 2.48/device2022-01: 0 reports for this device; peer average 2.68/device2022-02: 0 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 2.02/device2022-05: 0 reports for this device; peer average 1.94/device2022-06: 0 reports for this device; peer average 2.39/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 2.02/device2022-09: 0 reports for this device; peer average 2.31/device2022-10: 0 reports for this device; peer average 3.23/device2022-11: 0 reports for this device; peer average 2.86/device2022-12: 0 reports for this device; peer average 2.96/device2023-01: 0 reports for this device; peer average 2.54/device2023-02: 0 reports for this device; peer average 2.63/device2023-03: 0 reports for this device; peer average 2.88/device2023-04: 1 reports for this device; peer average 2.93/device2023-05: 0 reports for this device; peer average 3.99/device2023-06: 0 reports for this device; peer average 3.16/device2023-07: 0 reports for this device; peer average 3.44/device2023-08: 0 reports for this device; peer average 2.29/device2023-09: 0 reports for this device; peer average 2.09/device2023-10: 0 reports for this device; peer average 2.27/device2023-11: 0 reports for this device; peer average 2.13/device2023-12: 1 reports for this device; peer average 2.3/device2024-01: 0 reports for this device; peer average 2.16/device2024-02: 0 reports for this device; peer average 2.05/device2024-03: 0 reports for this device; peer average 1.95/device2024-04: 2 reports for this device; peer average 2.23/device2024-05: 0 reports for this device; peer average 1.96/device2024-06: 0 reports for this device; peer average 2.22/device2024-07: 0 reports for this device; peer average 2.11/device2024-08: 0 reports for this device; peer average 2.11/device2024-09: 0 reports for this device; peer average 1.7/device2024-10: 0 reports for this device; peer average 2.22/device2024-11: 0 reports for this device; peer average 1.7/device2024-12: 0 reports for this device; peer average 2.72/device2025-01: 0 reports for this device; peer average 1.65/device2025-02: 0 reports for this device; peer average 1.68/device2025-03: 0 reports for this device; peer average 2.58/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 2.1/device2025-06: 2 reports for this device; peer average 1.74/device2025-07: 1 reports for this device; peer average 2.18/device2025-08: 0 reports for this device; peer average 2.09/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 2/device2025-11: 2 reports for this device; peer average 1.82/device2025-12: 0 reports for this device; peer average 2.82/device2026-01: 0 reports for this device; peer average 1.72/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 2.67/device2026-04: 0 reports for this device; peer average 2.47/device2026-05: 0 reports for this device; peer average 2.04/device2026-06: 0 reports for this device; peer average 2.24/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.83
2019-0201.51
2019-0302.02
2019-0402.43
2019-0501.89
2019-0601.57
2019-0701.69
2019-0801.57
2019-0901.68
2019-1001.66
2019-1101.7
2019-1202.05
2020-0102.19
2020-0201.31
2020-0301.69
2020-0401.95
2020-0501.82
2020-0601.9
2020-0701.95
2020-0802.28
2020-0922.62
2020-1001.97
2020-1102.08
2020-1202.17
2021-0101.81
2021-0201.78
2021-0302.06
2021-0402.72
2021-0502.73
2021-0601.99
2021-0702.14
2021-0802.01
2021-0901.92
2021-1002.01
2021-1102.03
2021-1202.48
2022-0102.68
2022-0202.14
2022-0302.01
2022-0402.02
2022-0501.94
2022-0602.39
2022-0702.21
2022-0802.02
2022-0902.31
2022-1003.23
2022-1102.86
2022-1202.96
2023-0102.54
2023-0202.63
2023-0302.88
2023-0412.93
2023-0503.99
2023-0603.16
2023-0703.44
2023-0802.29
2023-0902.09
2023-1002.27
2023-1102.13
2023-1212.3
2024-0102.16
2024-0202.05
2024-0301.95
2024-0422.23
2024-0501.96
2024-0602.22
2024-0702.11
2024-0802.11
2024-0901.7
2024-1002.22
2024-1101.7
2024-1202.72
2025-0101.65
2025-0201.68
2025-0302.58
2025-0401.84
2025-0502.1
2025-0621.74
2025-0712.18
2025-0802.09
2025-0901.69
2025-1002
2025-1121.82
2025-1202.82
2026-0101.72
2026-0202
2026-0302.67
2026-0402.47
2026-0502.04
2026-0602.24
This device (reports/month)Average device in HRS, HTD, JEY (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-11-100001032347-2025-00434MalfunctionAvailablecatalog number
2025-07-160001032347-2025-00267MalfunctionAvailablecatalog number
2025-06-190001032347-2025-00236MalfunctionAvailablecatalog number
2024-04-090001032347-2024-00135MalfunctionAvailablecatalog number
2023-12-130001032347-2023-00459MalfunctionAvailablecatalog number
2023-04-040001032347-2023-00115MalfunctionAvailablecatalog number
2020-09-080001032347-2020-00429InjuryAvailablecatalog number

Showing the most recent 7 of 11 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-03-04VAIVoluntary action indicatedZimmer Biomet CMF and Thoracic LLC3
2018-05-24VAIVoluntary action indicatedZimmer Biomet CMF and Thoracic LLC1
2017-09-01VAIVoluntary action indicatedZimmer Biomet CMF and Thoracic LLC3
2015-10-30VAIVoluntary action indicatedZimmer Biomet CMF and Thoracic LLC1
2012-01-17VAIVoluntary action indicatedZimmer Biomet CMF and Thoracic LLC2
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