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.
185 linked reportsMalfunction 185
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.03 |
| 2019-02 | 0 | 2.07 |
| 2019-03 | 0 | 1.68 |
| 2019-04 | 0 | 2.01 |
| 2019-05 | 0 | 1.83 |
| 2019-06 | 0 | 2.19 |
| 2019-07 | 0 | 2.04 |
| 2019-08 | 0 | 2.24 |
| 2019-09 | 0 | 2.01 |
| 2019-10 | 1 | 2.44 |
| 2019-11 | 0 | 3.01 |
| 2019-12 | 1 | 2.42 |
| 2020-01 | 0 | 2.39 |
| 2020-02 | 0 | 2.82 |
| 2020-03 | 3 | 2.28 |
| 2020-04 | 3 | 2.21 |
| 2020-05 | 0 | 1.83 |
| 2020-06 | 1 | 2.09 |
| 2020-07 | 2 | 2.66 |
| 2020-08 | 2 | 2.72 |
| 2020-09 | 2 | 2.23 |
| 2020-10 | 0 | 2.94 |
| 2020-11 | 2 | 2.86 |
| 2020-12 | 3 | 2.95 |
| 2021-01 | 2 | 2.47 |
| 2021-02 | 4 | 2.45 |
| 2021-03 | 4 | 2.59 |
| 2021-04 | 4 | 2.45 |
| 2021-05 | 2 | 2.36 |
| 2021-06 | 4 | 2.18 |
| 2021-07 | 6 | 2.24 |
| 2021-08 | 2 | 1.88 |
| 2021-09 | 2 | 2.33 |
| 2021-10 | 3 | 1.96 |
| 2021-11 | 1 | 2.31 |
| 2021-12 | 4 | 2.33 |
| 2022-01 | 1 | 2.03 |
| 2022-02 | 3 | 2.38 |
| 2022-03 | 6 | 2.05 |
| 2022-04 | 4 | 2.1 |
| 2022-05 | 5 | 2.33 |
| 2022-06 | 2 | 2.03 |
| 2022-07 | 7 | 2.06 |
| 2022-08 | 3 | 2.1 |
| 2022-09 | 4 | 2.28 |
| 2022-10 | 4 | 2.2 |
| 2022-11 | 5 | 2.24 |
| 2022-12 | 5 | 1.9 |
| 2023-01 | 6 | 2.09 |
| 2023-02 | 5 | 2.23 |
| 2023-03 | 7 | 2.23 |
| 2023-04 | 4 | 2.26 |
| 2023-05 | 5 | 2.41 |
| 2023-06 | 2 | 2.26 |
| 2023-07 | 2 | 2 |
| 2023-08 | 4 | 1.71 |
| 2023-09 | 7 | 1.76 |
| 2023-10 | 10 | 1.63 |
| 2023-11 | 7 | 1.68 |
| 2023-12 | 5 | 1.7 |
| 2024-01 | 6 | 1.57 |
| 2024-02 | 0 | 1.74 |
| 2024-03 | 3 | 1.78 |
| 2024-04 | 3 | 1.64 |
| 2024-05 | 0 | 1.91 |
| 2024-06 | 2 | 1.98 |
| 2024-07 | 0 | 1.85 |
| 2024-08 | 0 | 2.31 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 1.99 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 2.09 |
| 2025-01 | 0 | 2.32 |
| 2025-02 | 0 | 1.83 |
| 2025-03 | 0 | 1.86 |
| 2025-04 | 0 | 1.66 |
| 2025-05 | 0 | 1.71 |
| 2025-06 | 0 | 1.81 |
| 2025-07 | 0 | 1.62 |
| 2025-08 | 0 | 1.63 |
| 2025-09 | 0 | 1.64 |
| 2025-10 | 0 | 1.43 |
| 2025-11 | 0 | 1.7 |
| 2025-12 | 0 | 1.66 |
| 2026-01 | 0 | 1.55 |
| 2026-02 | 0 | 1.53 |
| 2026-03 | 0 | 1.99 |
| 2026-04 | 0 | 1.75 |
| 2026-05 | 0 | 1.71 |
| 2026-06 | 0 | 1.7 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-06-07 | 0001822565-2024-01883 | Malfunction | Available | exact di |
| 2024-06-03 | 0001822565-2024-01837 | Malfunction | Available | exact di |
| 2024-04-24 | 0001822565-2024-01392 | Malfunction | Available | exact di |
| 2024-04-17 | 0001822565-2024-01286 | Malfunction | Available | exact di |
| 2024-04-10 | 0001822565-2024-01200 | Malfunction | Available | exact di |
| 2024-03-26 | 0001822565-2024-01016 | Malfunction | Available | exact di |
| 2024-03-25 | 0001822565-2024-00965 | Malfunction | Available | exact di |
| 2024-03-05 | 0001822565-2024-00747 | Malfunction | Available | exact di |
| 2024-01-23 | 0001822565-2024-00227 | Malfunction | Available | exact di |
| 2024-01-16 | 0001822565-2024-00146 | Malfunction | Available | exact di |
| 2024-01-16 | 0001822565-2024-00151 | Malfunction | Available | exact di |
| 2024-01-09 | 0001822565-2024-00098 | Malfunction | Available | exact di |
| 2024-01-05 | 0001822565-2024-00071 | Malfunction | Available | exact di |
| 2024-01-05 | 0001822565-2024-00075 | Malfunction | Available | exact di |
| 2023-12-27 | 0001822565-2023-03810 | Malfunction | Available | exact di |
Showing 1–15 of 185
Regulatory clearances
Predicate lineage
Cited as predicate by: K123692, K140027, K140833, K142787, K161592, K172524, K181947, K193223, K200209, K212129, K221479, K230078, K230321
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 |
|---|---|---|---|---|
| 2022-07-27 | NAI | No action indicated | Zimmer, Inc. | 0 |
| 2022-07-27 | NAI | No action indicated | Zimmer, Inc. | 0 |
| 2020-10-01 | NAI | No action indicated | Zimmer Manufacturing B.V. | 0 |
| 2017-10-16 | VAI | Voluntary action indicated | Zimmer, Inc. | 8 |
| 2017-10-16 | VAI | Voluntary action indicated | Zimmer, Inc. | 8 |
| 2017-09-01 | NAI | No action indicated | Zimmer Trabecular Metal Technology, Inc. | 0 |
| 2017-07-27 | VAI | Voluntary action indicated | ZIMMER ORTHOPEDIC MFG LTD | 3 |
| 2017-07-20 | VAI | Voluntary action indicated | Zimmer Manufacturing B.V. | 3 |
| 2016-05-27 | WL | Warning Letter | Orthosoft, Inc. | — |
| 2016-05-23 | VAI | Voluntary action indicated | Zimmer Surgical Inc | 4 |
| 2015-11-20 | OAI | Official action indicated | Zimmer, Inc. | 10 |
| 2015-11-20 | OAI | Official action indicated | Zimmer, Inc. | 10 |
| 2015-11-17 | VAI | Voluntary action indicated | Zimmer Manufacturing B.V. | 4 |
| 2015-05-11 | VAI | Voluntary action indicated | Zimmer Trabecular Metal Technology, Inc. | 3 |
| 2014-10-16 | VAI | Voluntary action indicated | ZIMMER ORTHOPEDIC MFG LTD | 2 |
| 2014-06-11 | OAI | Official action indicated | Zimmer Manufacturing B.V. | 9 |
| 2014-05-28 | OAI | Official action indicated | Zimmer, Inc. | 12 |
| 2014-05-28 | OAI | Official action indicated | Zimmer, Inc. | 12 |
| 2014-02-07 | VAI | Voluntary action indicated | Zimmer, Inc. | 2 |
| 2014-02-07 | VAI | Voluntary action indicated | Zimmer, Inc. | 2 |
| 2013-08-19 | OAI | Official action indicated | Zimmer, Inc. | 0 |
| 2012-09-19 | WL | Warning Letter | Zimmer Manufacturing B.V. | — |
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