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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.

2 linked reportsInjury 2
13462019-01: 0 reports for this device; peer average 1.68/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 1.57/device2019-04: 0 reports for this device; peer average 1.9/device2019-05: 0 reports for this device; peer average 1.77/device2019-06: 0 reports for this device; peer average 1.78/device2019-07: 0 reports for this device; peer average 1.44/device2019-08: 0 reports for this device; peer average 1.67/device2019-09: 0 reports for this device; peer average 1.79/device2019-10: 0 reports for this device; peer average 1.84/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1.33/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.73/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.22/device2020-06: 0 reports for this device; peer average 2.65/device2020-07: 0 reports for this device; peer average 2.32/device2020-08: 0 reports for this device; peer average 2.84/device2020-09: 0 reports for this device; peer average 1.82/device2020-10: 0 reports for this device; peer average 1.79/device2020-11: 0 reports for this device; peer average 2.82/device2020-12: 0 reports for this device; peer average 2.14/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 2.44/device2021-03: 0 reports for this device; peer average 2.1/device2021-04: 0 reports for this device; peer average 2.7/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.92/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2.19/device2021-09: 0 reports for this device; peer average 2.68/device2021-10: 0 reports for this device; peer average 3.73/device2021-11: 0 reports for this device; peer average 2.31/device2021-12: 0 reports for this device; peer average 2.88/device2022-01: 0 reports for this device; peer average 1.82/device2022-02: 0 reports for this device; peer average 2.21/device2022-03: 0 reports for this device; peer average 2.9/device2022-04: 0 reports for this device; peer average 2.47/device2022-05: 0 reports for this device; peer average 2.4/device2022-06: 0 reports for this device; peer average 2.3/device2022-07: 0 reports for this device; peer average 2.82/device2022-08: 0 reports for this device; peer average 2.06/device2022-09: 0 reports for this device; peer average 5.83/device2022-10: 0 reports for this device; peer average 2.15/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 2.67/device2023-03: 2 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2.59/device2023-06: 0 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.22/device2023-08: 0 reports for this device; peer average 2.39/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 1.84/device2023-11: 0 reports for this device; peer average 2.12/device2023-12: 0 reports for this device; peer average 1.62/device2024-01: 0 reports for this device; peer average 2.67/device2024-02: 0 reports for this device; peer average 1.64/device2024-03: 0 reports for this device; peer average 1.91/device2024-04: 0 reports for this device; peer average 2.06/device2024-05: 0 reports for this device; peer average 1.77/device2024-06: 0 reports for this device; peer average 1.63/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1.43/device2024-09: 0 reports for this device; peer average 1.56/device2024-10: 0 reports for this device; peer average 1.84/device2024-11: 0 reports for this device; peer average 1.61/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1.78/device2025-02: 0 reports for this device; peer average 1.62/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.58/device2025-05: 0 reports for this device; peer average 1.54/device2025-06: 0 reports for this device; peer average 1.71/device2025-07: 0 reports for this device; peer average 2.19/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.83/device2025-11: 0 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 1.61/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.9/device2026-03: 0 reports for this device; peer average 2.28/device2026-04: 0 reports for this device; peer average 1.69/device2026-05: 0 reports for this device; peer average 2.13/device2026-06: 0 reports for this device; peer average 2.29/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.68
2019-0201.71
2019-0301.57
2019-0401.9
2019-0501.77
2019-0601.78
2019-0701.44
2019-0801.67
2019-0901.79
2019-1001.84
2019-1101.25
2019-1202
2020-0101.33
2020-0202.07
2020-0302.73
2020-0401.43
2020-0501.22
2020-0602.65
2020-0702.32
2020-0802.84
2020-0901.82
2020-1001.79
2020-1102.82
2020-1202.14
2021-0102.13
2021-0202.44
2021-0302.1
2021-0402.7
2021-0502
2021-0602.92
2021-0703
2021-0802.19
2021-0902.68
2021-1003.73
2021-1102.31
2021-1202.88
2022-0101.82
2022-0202.21
2022-0302.9
2022-0402.47
2022-0502.4
2022-0602.3
2022-0702.82
2022-0802.06
2022-0905.83
2022-1002.15
2022-1102
2022-1202
2023-0102.5
2023-0202.67
2023-0322.44
2023-0402
2023-0502.59
2023-0603.19
2023-0702.22
2023-0802.39
2023-0901.5
2023-1001.84
2023-1102.12
2023-1201.62
2024-0102.67
2024-0201.64
2024-0301.91
2024-0402.06
2024-0501.77
2024-0601.63
2024-0702
2024-0801.43
2024-0901.56
2024-1001.84
2024-1101.61
2024-1202
2025-0101.78
2025-0201.62
2025-0301.75
2025-0401.58
2025-0501.54
2025-0601.71
2025-0702.19
2025-0802
2025-0901.67
2025-1001.83
2025-1101.73
2025-1201.61
2026-0101.89
2026-0201.9
2026-0302.28
2026-0401.69
2026-0502.13
2026-0602.29
This device (reports/month)Average device in HSX (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-03-300001822565-2023-00865InjuryAvailableexact di
2023-03-300001822565-2023-00866InjuryAvailableexact di
Regulatory clearances

    Predicate lineage

    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
    DateTypeOutcomeFacilityCitations
    2022-07-27NAINo action indicatedZimmer, Inc.0
    2022-07-27NAINo action indicatedZimmer, Inc.0
    2020-10-01NAINo action indicatedZimmer Manufacturing B.V.0
    2017-10-16VAIVoluntary action indicatedZimmer, Inc.8
    2017-10-16VAIVoluntary action indicatedZimmer, Inc.8
    2017-09-01NAINo action indicatedZimmer Trabecular Metal Technology, Inc.0
    2017-07-27VAIVoluntary action indicatedZIMMER ORTHOPEDIC MFG LTD3
    2017-07-20VAIVoluntary action indicatedZimmer Manufacturing B.V.3
    2016-05-27WLWarning LetterOrthosoft, Inc.—
    2016-05-23VAIVoluntary action indicatedZimmer Surgical Inc4
    2015-11-20OAIOfficial action indicatedZimmer, Inc.10
    2015-11-20OAIOfficial action indicatedZimmer, Inc.10
    2015-11-17VAIVoluntary action indicatedZimmer Manufacturing B.V.4
    2015-05-11VAIVoluntary action indicatedZimmer Trabecular Metal Technology, Inc.3
    2014-10-16VAIVoluntary action indicatedZIMMER ORTHOPEDIC MFG LTD2
    2014-06-11OAIOfficial action indicatedZimmer Manufacturing B.V.9
    2014-05-28OAIOfficial action indicatedZimmer, Inc.12
    2014-05-28OAIOfficial action indicatedZimmer, Inc.12
    2014-02-07VAIVoluntary action indicatedZimmer, Inc.2
    2014-02-07VAIVoluntary action indicatedZimmer, Inc.2
    2013-08-19OAIOfficial action indicatedZimmer, Inc.0
    2012-09-19WLWarning LetterZimmer Manufacturing B.V.—
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