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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.

274 linked reportsInjury 274
358102019-01: 3 reports for this device; peer average 1.88/device2019-02: 2 reports for this device; peer average 1.44/device2019-03: 0 reports for this device; peer average 1.27/device2019-04: 5 reports for this device; peer average 2.33/device2019-05: 4 reports for this device; peer average 2.31/device2019-06: 0 reports for this device; peer average 2/device2019-07: 2 reports for this device; peer average 1.71/device2019-08: 3 reports for this device; peer average 2.15/device2019-09: 3 reports for this device; peer average 1.69/device2019-10: 0 reports for this device; peer average 2.11/device2019-11: 0 reports for this device; peer average 1.36/device2019-12: 6 reports for this device; peer average 2.15/device2020-01: 0 reports for this device; peer average 1.79/device2020-02: 3 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.83/device2020-04: 3 reports for this device; peer average 1.38/device2020-05: 6 reports for this device; peer average 2.18/device2020-06: 8 reports for this device; peer average 2.32/device2020-07: 0 reports for this device; peer average 1.88/device2020-08: 0 reports for this device; peer average 2.32/device2020-09: 3 reports for this device; peer average 2.5/device2020-10: 9 reports for this device; peer average 2.65/device2020-11: 6 reports for this device; peer average 2.54/device2020-12: 4 reports for this device; peer average 1.92/device2021-01: 3 reports for this device; peer average 2/device2021-02: 5 reports for this device; peer average 1.52/device2021-03: 0 reports for this device; peer average 1.81/device2021-04: 9 reports for this device; peer average 1.97/device2021-05: 3 reports for this device; peer average 1.41/device2021-06: 3 reports for this device; peer average 1.41/device2021-07: 3 reports for this device; peer average 2.47/device2021-08: 3 reports for this device; peer average 2.5/device2021-09: 10 reports for this device; peer average 1.88/device2021-10: 3 reports for this device; peer average 2.21/device2021-11: 6 reports for this device; peer average 1.82/device2021-12: 0 reports for this device; peer average 2.3/device2022-01: 0 reports for this device; peer average 2.25/device2022-02: 0 reports for this device; peer average 2.64/device2022-03: 9 reports for this device; peer average 2.26/device2022-04: 1 reports for this device; peer average 2.19/device2022-05: 0 reports for this device; peer average 1.68/device2022-06: 5 reports for this device; peer average 2.69/device2022-07: 6 reports for this device; peer average 2.44/device2022-08: 3 reports for this device; peer average 2.08/device2022-09: 0 reports for this device; peer average 1.98/device2022-10: 2 reports for this device; peer average 1.64/device2022-11: 3 reports for this device; peer average 1.92/device2022-12: 7 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1.71/device2023-02: 0 reports for this device; peer average 1.67/device2023-03: 0 reports for this device; peer average 1.63/device2023-04: 2 reports for this device; peer average 1.66/device2023-05: 4 reports for this device; peer average 1.7/device2023-06: 3 reports for this device; peer average 1.75/device2023-07: 2 reports for this device; peer average 1.97/device2023-08: 6 reports for this device; peer average 1.7/device2023-09: 6 reports for this device; peer average 1.48/device2023-10: 2 reports for this device; peer average 1.44/device2023-11: 6 reports for this device; peer average 1.66/device2023-12: 2 reports for this device; peer average 1.37/device2024-01: 0 reports for this device; peer average 1.6/device2024-02: 0 reports for this device; peer average 2.17/device2024-03: 5 reports for this device; peer average 1.63/device2024-04: 2 reports for this device; peer average 1.89/device2024-05: 3 reports for this device; peer average 1.7/device2024-06: 4 reports for this device; peer average 1.88/device2024-07: 2 reports for this device; peer average 1.6/device2024-08: 4 reports for this device; peer average 1.62/device2024-09: 4 reports for this device; peer average 1.81/device2024-10: 2 reports for this device; peer average 1.74/device2024-11: 4 reports for this device; peer average 1.8/device2024-12: 5 reports for this device; peer average 1.89/device2025-01: 0 reports for this device; peer average 1.79/device2025-02: 7 reports for this device; peer average 1.81/device2025-03: 4 reports for this device; peer average 1.75/device2025-04: 2 reports for this device; peer average 2.24/device2025-05: 4 reports for this device; peer average 2.2/device2025-06: 4 reports for this device; peer average 1.84/device2025-07: 2 reports for this device; peer average 1.52/device2025-08: 9 reports for this device; peer average 1.95/device2025-09: 2 reports for this device; peer average 1.36/device2025-10: 1 reports for this device; peer average 1.54/device2025-11: 5 reports for this device; peer average 1.73/device2025-12: 2 reports for this device; peer average 2.04/device2026-01: 2 reports for this device; peer average 1.76/device2026-02: 0 reports for this device; peer average 1.47/device2026-03: 0 reports for this device; peer average 1.7/device2026-04: 2 reports for this device; peer average 1.72/device2026-05: 4 reports for this device; peer average 1.59/device2026-06: 2 reports for this device; peer average 1.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0131.88
2019-0221.44
2019-0301.27
2019-0452.33
2019-0542.31
2019-0602
2019-0721.71
2019-0832.15
2019-0931.69
2019-1002.11
2019-1101.36
2019-1262.15
2020-0101.79
2020-0232.04
2020-0301.83
2020-0431.38
2020-0562.18
2020-0682.32
2020-0701.88
2020-0802.32
2020-0932.5
2020-1092.65
2020-1162.54
2020-1241.92
2021-0132
2021-0251.52
2021-0301.81
2021-0491.97
2021-0531.41
2021-0631.41
2021-0732.47
2021-0832.5
2021-09101.88
2021-1032.21
2021-1161.82
2021-1202.3
2022-0102.25
2022-0202.64
2022-0392.26
2022-0412.19
2022-0501.68
2022-0652.69
2022-0762.44
2022-0832.08
2022-0901.98
2022-1021.64
2022-1131.92
2022-1272
2023-0101.71
2023-0201.67
2023-0301.63
2023-0421.66
2023-0541.7
2023-0631.75
2023-0721.97
2023-0861.7
2023-0961.48
2023-1021.44
2023-1161.66
2023-1221.37
2024-0101.6
2024-0202.17
2024-0351.63
2024-0421.89
2024-0531.7
2024-0641.88
2024-0721.6
2024-0841.62
2024-0941.81
2024-1021.74
2024-1141.8
2024-1251.89
2025-0101.79
2025-0271.81
2025-0341.75
2025-0422.24
2025-0542.2
2025-0641.84
2025-0721.52
2025-0891.95
2025-0921.36
2025-1011.54
2025-1151.73
2025-1222.04
2026-0121.76
2026-0201.47
2026-0301.7
2026-0421.72
2026-0541.59
2026-0621.56
This device (reports/month)Average device in KWT (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-08-15Z-2561-2025Class IIOpen, ClassifiedReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.61,334 UNITScode info di
2024-03-06Z-1418-2024Class IIOpen, ClassifiedThe packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand66646 unitscode info di
2023-11-21Z-0579-2024Class IIOpen, ClassifiedExactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.Distribution: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UKN/Acode info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-121038671-2026-00770InjuryAvailablecatalog number
2026-05-191038671-2026-00622InjuryAvailablecatalog number
2026-05-051038671-2026-00539InjuryAvailablecatalog number
2026-04-151038671-2026-00432InjuryAvailablecatalog number
2026-01-131038671-2026-00042InjuryAvailablecatalog number
2025-12-031038671-2025-03478InjuryAvailablecatalog number
2025-11-141038671-2025-03333InjuryAvailablecatalog number
2025-11-071038671-2025-03292InjuryAvailablecatalog number
2025-11-061038671-2025-03282InjuryAvailablecatalog number
2025-10-071038671-2025-03054InjuryAvailablecatalog number
2025-09-091038671-2025-02900InjuryAvailablecatalog number
2025-08-261038671-2025-02844InjuryAvailablecatalog number
2025-08-201038671-2025-02796InjuryAvailablecatalog number
2025-08-131038671-2025-02751InjuryAvailablecatalog number
2025-08-081038671-2025-02711InjuryAvailablecatalog number

Showing the most recent 128 of 274 linked reports.

Showing 1–15 of 128
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
    2025-12-19WLWarning LetterExactech Sarasota, Inc.—
    2025-08-27OAIOfficial action indicatedExactech, Inc.9
    2025-08-27OAIOfficial action indicatedExactech, Inc.9
    2025-07-25OAIOfficial action indicatedExactech Sarasota, Inc.7
    2024-10-09VAIVoluntary action indicatedExactech, Inc.0
    2024-10-09VAIVoluntary action indicatedExactech, Inc.0
    2024-01-19WLWarning LetterExactech, Inc.—
    2024-01-19WLWarning LetterExactech, Inc.—
    2023-09-26OAIOfficial action indicatedExactech, Inc.2
    2023-09-26OAIOfficial action indicatedExactech, Inc.2
    2021-11-17VAIVoluntary action indicatedExactech, Inc.4
    2021-11-17VAIVoluntary action indicatedExactech, Inc.4
    2020-01-31VAIVoluntary action indicatedExactech, Inc.7
    2020-01-31VAIVoluntary action indicatedExactech, Inc.7
    2017-03-10VAIVoluntary action indicatedExactech, Inc.7
    2017-03-10VAIVoluntary action indicatedExactech, Inc.7
    2015-07-16NAINo action indicatedExactech, Inc.0
    2015-07-16NAINo action indicatedExactech, Inc.0
    2014-08-25NAINo action indicatedExactech Sarasota, Inc.0
    2012-12-11NAINo action indicatedExactech, Inc.0
    2012-12-11NAINo action indicatedExactech, Inc.0
    2010-03-25VAIVoluntary action indicatedExactech, Inc.0
    2010-03-25VAIVoluntary action indicatedExactech, Inc.0
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