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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.

419 linked reportsMalfunction 418Injury 1
51014192019-01: 0 reports for this device; peer average 2.03/device2019-02: 0 reports for this device; peer average 2.07/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 2.01/device2019-05: 0 reports for this device; peer average 1.83/device2019-06: 0 reports for this device; peer average 2.19/device2019-07: 0 reports for this device; peer average 2.04/device2019-08: 0 reports for this device; peer average 2.24/device2019-09: 0 reports for this device; peer average 2.01/device2019-10: 0 reports for this device; peer average 2.44/device2019-11: 0 reports for this device; peer average 3.01/device2019-12: 1 reports for this device; peer average 2.42/device2020-01: 0 reports for this device; peer average 2.39/device2020-02: 0 reports for this device; peer average 2.82/device2020-03: 0 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.21/device2020-05: 0 reports for this device; peer average 1.83/device2020-06: 0 reports for this device; peer average 2.09/device2020-07: 0 reports for this device; peer average 2.66/device2020-08: 0 reports for this device; peer average 2.72/device2020-09: 1 reports for this device; peer average 2.23/device2020-10: 2 reports for this device; peer average 2.94/device2020-11: 0 reports for this device; peer average 2.86/device2020-12: 0 reports for this device; peer average 2.95/device2021-01: 0 reports for this device; peer average 2.47/device2021-02: 0 reports for this device; peer average 2.45/device2021-03: 0 reports for this device; peer average 2.59/device2021-04: 2 reports for this device; peer average 2.45/device2021-05: 2 reports for this device; peer average 2.36/device2021-06: 2 reports for this device; peer average 2.18/device2021-07: 3 reports for this device; peer average 2.24/device2021-08: 2 reports for this device; peer average 1.88/device2021-09: 0 reports for this device; peer average 2.33/device2021-10: 1 reports for this device; peer average 1.96/device2021-11: 1 reports for this device; peer average 2.31/device2021-12: 2 reports for this device; peer average 2.33/device2022-01: 1 reports for this device; peer average 2.03/device2022-02: 5 reports for this device; peer average 2.38/device2022-03: 7 reports for this device; peer average 2.05/device2022-04: 3 reports for this device; peer average 2.1/device2022-05: 0 reports for this device; peer average 2.33/device2022-06: 5 reports for this device; peer average 2.03/device2022-07: 1 reports for this device; peer average 2.06/device2022-08: 4 reports for this device; peer average 2.1/device2022-09: 3 reports for this device; peer average 2.28/device2022-10: 3 reports for this device; peer average 2.2/device2022-11: 3 reports for this device; peer average 2.24/device2022-12: 0 reports for this device; peer average 1.9/device2023-01: 8 reports for this device; peer average 2.09/device2023-02: 5 reports for this device; peer average 2.23/device2023-03: 7 reports for this device; peer average 2.23/device2023-04: 5 reports for this device; peer average 2.26/device2023-05: 8 reports for this device; peer average 2.41/device2023-06: 8 reports for this device; peer average 2.26/device2023-07: 8 reports for this device; peer average 2/device2023-08: 6 reports for this device; peer average 1.71/device2023-09: 5 reports for this device; peer average 1.76/device2023-10: 3 reports for this device; peer average 1.63/device2023-11: 7 reports for this device; peer average 1.68/device2023-12: 13 reports for this device; peer average 1.7/device2024-01: 10 reports for this device; peer average 1.57/device2024-02: 5 reports for this device; peer average 1.74/device2024-03: 11 reports for this device; peer average 1.78/device2024-04: 15 reports for this device; peer average 1.64/device2024-05: 4 reports for this device; peer average 1.91/device2024-06: 11 reports for this device; peer average 1.98/device2024-07: 4 reports for this device; peer average 1.85/device2024-08: 14 reports for this device; peer average 2.31/device2024-09: 9 reports for this device; peer average 2/device2024-10: 11 reports for this device; peer average 1.99/device2024-11: 9 reports for this device; peer average 2/device2024-12: 13 reports for this device; peer average 2.09/device2025-01: 12 reports for this device; peer average 2.32/device2025-02: 12 reports for this device; peer average 1.83/device2025-03: 12 reports for this device; peer average 1.86/device2025-04: 11 reports for this device; peer average 1.66/device2025-05: 9 reports for this device; peer average 1.71/device2025-06: 7 reports for this device; peer average 1.81/device2025-07: 5 reports for this device; peer average 1.62/device2025-08: 6 reports for this device; peer average 1.63/device2025-09: 8 reports for this device; peer average 1.64/device2025-10: 8 reports for this device; peer average 1.43/device2025-11: 8 reports for this device; peer average 1.7/device2025-12: 19 reports for this device; peer average 1.66/device2026-01: 9 reports for this device; peer average 1.55/device2026-02: 12 reports for this device; peer average 1.53/device2026-03: 11 reports for this device; peer average 1.99/device2026-04: 5 reports for this device; peer average 1.75/device2026-05: 5 reports for this device; peer average 1.71/device2026-06: 7 reports for this device; peer average 1.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.03
2019-0202.07
2019-0301.68
2019-0402.01
2019-0501.83
2019-0602.19
2019-0702.04
2019-0802.24
2019-0902.01
2019-1002.44
2019-1103.01
2019-1212.42
2020-0102.39
2020-0202.82
2020-0302.28
2020-0402.21
2020-0501.83
2020-0602.09
2020-0702.66
2020-0802.72
2020-0912.23
2020-1022.94
2020-1102.86
2020-1202.95
2021-0102.47
2021-0202.45
2021-0302.59
2021-0422.45
2021-0522.36
2021-0622.18
2021-0732.24
2021-0821.88
2021-0902.33
2021-1011.96
2021-1112.31
2021-1222.33
2022-0112.03
2022-0252.38
2022-0372.05
2022-0432.1
2022-0502.33
2022-0652.03
2022-0712.06
2022-0842.1
2022-0932.28
2022-1032.2
2022-1132.24
2022-1201.9
2023-0182.09
2023-0252.23
2023-0372.23
2023-0452.26
2023-0582.41
2023-0682.26
2023-0782
2023-0861.71
2023-0951.76
2023-1031.63
2023-1171.68
2023-12131.7
2024-01101.57
2024-0251.74
2024-03111.78
2024-04151.64
2024-0541.91
2024-06111.98
2024-0741.85
2024-08142.31
2024-0992
2024-10111.99
2024-1192
2024-12132.09
2025-01122.32
2025-02121.83
2025-03121.86
2025-04111.66
2025-0591.71
2025-0671.81
2025-0751.62
2025-0861.63
2025-0981.64
2025-1081.43
2025-1181.7
2025-12191.66
2026-0191.55
2026-02121.53
2026-03111.99
2026-0451.75
2026-0551.71
2026-0671.7
This device (reports/month)Average device in JWH (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
DateReport #TypeNarrativeLink basis
2026-06-290001822565-2026-02314MalfunctionAvailableexact di
2026-06-230001822565-2026-02091MalfunctionAvailableexact di
2026-06-230001822565-2026-02111MalfunctionAvailableexact di
2026-06-230001822565-2026-02092MalfunctionAvailableexact di
2026-06-220001822565-2026-02025MalfunctionAvailableexact di
2026-06-150001822565-2026-01916MalfunctionAvailableexact di
2026-06-010001822565-2026-01739MalfunctionAvailableexact di
2026-05-190001822565-2026-01642MalfunctionAvailableexact di
2026-05-180001822565-2026-01610MalfunctionAvailableexact di
2026-05-140001822565-2026-01574MalfunctionAvailableexact di
2026-05-110001822565-2026-01517MalfunctionAvailableexact di
2026-05-110001822565-2026-01518MalfunctionAvailableexact di
2026-04-300001822565-2026-01424MalfunctionAvailableexact di
2026-04-300001822565-2026-01426MalfunctionAvailableexact di
2026-04-200001822565-2026-01323MalfunctionAvailableexact di

Showing the most recent 200 of 419 linked reports.

Showing 1–15 of 200
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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