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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.

3 linked reportsInjury 3
11232019-01: 0 reports for this device; peer average 1.92/device2019-02: 0 reports for this device; peer average 1.97/device2019-03: 0 reports for this device; peer average 1.63/device2019-04: 0 reports for this device; peer average 1.91/device2019-05: 0 reports for this device; peer average 1.73/device2019-06: 0 reports for this device; peer average 2.03/device2019-07: 0 reports for this device; peer average 1.96/device2019-08: 0 reports for this device; peer average 2.12/device2019-09: 0 reports for this device; peer average 1.86/device2019-10: 0 reports for this device; peer average 2.23/device2019-11: 0 reports for this device; peer average 2.74/device2019-12: 0 reports for this device; peer average 2.25/device2020-01: 0 reports for this device; peer average 2.22/device2020-02: 0 reports for this device; peer average 2.57/device2020-03: 0 reports for this device; peer average 2.1/device2020-04: 0 reports for this device; peer average 2.04/device2020-05: 0 reports for this device; peer average 1.71/device2020-06: 0 reports for this device; peer average 1.98/device2020-07: 0 reports for this device; peer average 2.48/device2020-08: 0 reports for this device; peer average 2.53/device2020-09: 0 reports for this device; peer average 2.1/device2020-10: 0 reports for this device; peer average 2.64/device2020-11: 0 reports for this device; peer average 2.59/device2020-12: 0 reports for this device; peer average 2.68/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 2.25/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.24/device2021-05: 0 reports for this device; peer average 2.16/device2021-06: 0 reports for this device; peer average 2.05/device2021-07: 0 reports for this device; peer average 2.05/device2021-08: 0 reports for this device; peer average 1.76/device2021-09: 0 reports for this device; peer average 2.14/device2021-10: 0 reports for this device; peer average 1.81/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.17/device2022-01: 0 reports for this device; peer average 1.88/device2022-02: 0 reports for this device; peer average 2.19/device2022-03: 0 reports for this device; peer average 1.89/device2022-04: 0 reports for this device; peer average 1.94/device2022-05: 0 reports for this device; peer average 2.12/device2022-06: 0 reports for this device; peer average 1.87/device2022-07: 0 reports for this device; peer average 1.93/device2022-08: 0 reports for this device; peer average 1.94/device2022-09: 0 reports for this device; peer average 2.06/device2022-10: 0 reports for this device; peer average 2.03/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 1.78/device2023-01: 0 reports for this device; peer average 1.92/device2023-02: 0 reports for this device; peer average 2.04/device2023-03: 0 reports for this device; peer average 2.04/device2023-04: 0 reports for this device; peer average 2.1/device2023-05: 0 reports for this device; peer average 2.23/device2023-06: 0 reports for this device; peer average 2.1/device2023-07: 0 reports for this device; peer average 1.88/device2023-08: 0 reports for this device; peer average 1.6/device2023-09: 0 reports for this device; peer average 1.64/device2023-10: 0 reports for this device; peer average 1.53/device2023-11: 0 reports for this device; peer average 1.59/device2023-12: 0 reports for this device; peer average 1.6/device2024-01: 0 reports for this device; peer average 1.47/device2024-02: 0 reports for this device; peer average 1.63/device2024-03: 0 reports for this device; peer average 1.67/device2024-04: 0 reports for this device; peer average 1.55/device2024-05: 0 reports for this device; peer average 1.76/device2024-06: 2 reports for this device; peer average 1.84/device2024-07: 0 reports for this device; peer average 1.7/device2024-08: 0 reports for this device; peer average 2.18/device2024-09: 0 reports for this device; peer average 1.87/device2024-10: 0 reports for this device; peer average 1.85/device2024-11: 1 reports for this device; peer average 1.81/device2024-12: 0 reports for this device; peer average 1.92/device2025-01: 0 reports for this device; peer average 2.12/device2025-02: 0 reports for this device; peer average 1.71/device2025-03: 0 reports for this device; peer average 1.69/device2025-04: 0 reports for this device; peer average 1.57/device2025-05: 0 reports for this device; peer average 1.61/device2025-06: 0 reports for this device; peer average 1.71/device2025-07: 0 reports for this device; peer average 1.55/device2025-08: 0 reports for this device; peer average 1.58/device2025-09: 0 reports for this device; peer average 1.54/device2025-10: 0 reports for this device; peer average 1.38/device2025-11: 0 reports for this device; peer average 1.6/device2025-12: 0 reports for this device; peer average 1.57/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1.49/device2026-03: 0 reports for this device; peer average 1.81/device2026-04: 0 reports for this device; peer average 1.62/device2026-05: 0 reports for this device; peer average 1.59/device2026-06: 0 reports for this device; peer average 1.58/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.92
2019-0201.97
2019-0301.63
2019-0401.91
2019-0501.73
2019-0602.03
2019-0701.96
2019-0802.12
2019-0901.86
2019-1002.23
2019-1102.74
2019-1202.25
2020-0102.22
2020-0202.57
2020-0302.1
2020-0402.04
2020-0501.71
2020-0601.98
2020-0702.48
2020-0802.53
2020-0902.1
2020-1002.64
2020-1102.59
2020-1202.68
2021-0102.25
2021-0202.25
2021-0302.39
2021-0402.24
2021-0502.16
2021-0602.05
2021-0702.05
2021-0801.76
2021-0902.14
2021-1001.81
2021-1102.1
2021-1202.17
2022-0101.88
2022-0202.19
2022-0301.89
2022-0401.94
2022-0502.12
2022-0601.87
2022-0701.93
2022-0801.94
2022-0902.06
2022-1002.03
2022-1102.09
2022-1201.78
2023-0101.92
2023-0202.04
2023-0302.04
2023-0402.1
2023-0502.23
2023-0602.1
2023-0701.88
2023-0801.6
2023-0901.64
2023-1001.53
2023-1101.59
2023-1201.6
2024-0101.47
2024-0201.63
2024-0301.67
2024-0401.55
2024-0501.76
2024-0621.84
2024-0701.7
2024-0802.18
2024-0901.87
2024-1001.85
2024-1111.81
2024-1201.92
2025-0102.12
2025-0201.71
2025-0301.69
2025-0401.57
2025-0501.61
2025-0601.71
2025-0701.55
2025-0801.58
2025-0901.54
2025-1001.38
2025-1101.6
2025-1201.57
2026-0101.5
2026-0201.49
2026-0301.81
2026-0401.62
2026-0501.59
2026-0601.58
This device (reports/month)Average device in JWH, MBH, MLR (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-11-270002648920-2024-00363InjuryAvailableexact di
2024-06-200001822565-2024-02080InjuryAvailableexact di
2024-06-180001822565-2024-02030InjuryAvailableexact di
Regulatory clearances

    Predicate lineage

    K070214

    Cited as predicate by: K110950, K131310, K173057

    K073286

    Cited as predicate by: K102927, K110950, K113369

    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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