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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.68 |
| 2019-02 | 0 | 1.59 |
| 2019-03 | 0 | 1.68 |
| 2019-04 | 0 | 1.52 |
| 2019-05 | 0 | 1.76 |
| 2019-06 | 0 | 1.87 |
| 2019-07 | 0 | 1.41 |
| 2019-08 | 0 | 1.97 |
| 2019-09 | 0 | 1.48 |
| 2019-10 | 0 | 1.8 |
| 2019-11 | 0 | 1.62 |
| 2019-12 | 0 | 1.74 |
| 2020-01 | 0 | 1.89 |
| 2020-02 | 0 | 2.15 |
| 2020-03 | 0 | 1.76 |
| 2020-04 | 0 | 1.72 |
| 2020-05 | 0 | 1.43 |
| 2020-06 | 0 | 1.8 |
| 2020-07 | 0 | 1.91 |
| 2020-08 | 0 | 1.63 |
| 2020-09 | 0 | 1.92 |
| 2020-10 | 0 | 2.1 |
| 2020-11 | 0 | 1.85 |
| 2020-12 | 0 | 1.82 |
| 2021-01 | 0 | 1.95 |
| 2021-02 | 0 | 1.82 |
| 2021-03 | 0 | 1.98 |
| 2021-04 | 0 | 1.76 |
| 2021-05 | 0 | 1.76 |
| 2021-06 | 0 | 1.63 |
| 2021-07 | 0 | 1.87 |
| 2021-08 | 0 | 2.03 |
| 2021-09 | 0 | 1.66 |
| 2021-10 | 0 | 1.71 |
| 2021-11 | 0 | 1.97 |
| 2021-12 | 0 | 1.93 |
| 2022-01 | 0 | 2.04 |
| 2022-02 | 0 | 2.04 |
| 2022-03 | 1 | 1.73 |
| 2022-04 | 0 | 2.04 |
| 2022-05 | 0 | 1.88 |
| 2022-06 | 0 | 2.01 |
| 2022-07 | 0 | 2.05 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.84 |
| 2022-10 | 0 | 1.87 |
| 2022-11 | 0 | 2.02 |
| 2022-12 | 0 | 1.82 |
| 2023-01 | 0 | 1.72 |
| 2023-02 | 0 | 1.94 |
| 2023-03 | 0 | 1.93 |
| 2023-04 | 0 | 1.92 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 2.26 |
| 2023-07 | 0 | 2.07 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 0 | 1.51 |
| 2023-10 | 0 | 1.56 |
| 2023-11 | 0 | 1.61 |
| 2023-12 | 0 | 1.41 |
| 2024-01 | 0 | 1.99 |
| 2024-02 | 0 | 1.76 |
| 2024-03 | 0 | 1.68 |
| 2024-04 | 0 | 1.77 |
| 2024-05 | 0 | 1.72 |
| 2024-06 | 0 | 1.9 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1.7 |
| 2024-09 | 0 | 1.71 |
| 2024-10 | 0 | 1.61 |
| 2024-11 | 0 | 1.58 |
| 2024-12 | 0 | 1.63 |
| 2025-01 | 0 | 1.72 |
| 2025-02 | 0 | 1.56 |
| 2025-03 | 0 | 1.84 |
| 2025-04 | 0 | 1.63 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 0 | 1.83 |
| 2025-07 | 0 | 1.71 |
| 2025-08 | 0 | 1.53 |
| 2025-09 | 0 | 1.51 |
| 2025-10 | 0 | 1.62 |
| 2025-11 | 0 | 1.71 |
| 2025-12 | 0 | 2.11 |
| 2026-01 | 0 | 1.87 |
| 2026-02 | 0 | 1.8 |
| 2026-03 | 0 | 1.75 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 0 | 1.75 |
| 2026-06 | 0 | 1.68 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-03-06 | Z-1410-2024 | Class II | Open, Classified | The 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, Thailand | 180 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-03-28 | 1038671-2022-00297 | Injury | Available | exact 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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-12-19 | WL | Warning Letter | Exactech Sarasota, Inc. | — |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-07-25 | OAI | Official action indicated | Exactech Sarasota, Inc. | 7 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2014-08-25 | NAI | No action indicated | Exactech Sarasota, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
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