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.
41 linked reports Injury 40Malfunction 1
1 2 3 4 2019-01: 0 reports for this device; peer average 2.99/device 2019-02: 2 reports for this device; peer average 2.56/device 2019-03: 1 reports for this device; peer average 2.88/device 2019-04: 0 reports for this device; peer average 2.72/device 2019-05: 1 reports for this device; peer average 2.13/device 2019-06: 0 reports for this device; peer average 1.85/device 2019-07: 0 reports for this device; peer average 1.85/device 2019-08: 4 reports for this device; peer average 2.16/device 2019-09: 2 reports for this device; peer average 2.36/device 2019-10: 1 reports for this device; peer average 2.57/device 2019-11: 0 reports for this device; peer average 2.16/device 2019-12: 1 reports for this device; peer average 2.45/device 2020-01: 0 reports for this device; peer average 2.81/device 2020-02: 1 reports for this device; peer average 2.54/device 2020-03: 0 reports for this device; peer average 3.24/device 2020-04: 0 reports for this device; peer average 2.27/device 2020-05: 0 reports for this device; peer average 2.22/device 2020-06: 1 reports for this device; peer average 2.06/device 2020-07: 0 reports for this device; peer average 2.55/device 2020-08: 1 reports for this device; peer average 2.03/device 2020-09: 2 reports for this device; peer average 2.53/device 2020-10: 2 reports for this device; peer average 2.53/device 2020-11: 1 reports for this device; peer average 2.31/device 2020-12: 2 reports for this device; peer average 2.32/device 2021-01: 2 reports for this device; peer average 2.44/device 2021-02: 0 reports for this device; peer average 2.05/device 2021-03: 0 reports for this device; peer average 2.05/device 2021-04: 2 reports for this device; peer average 2.07/device 2021-05: 0 reports for this device; peer average 1.99/device 2021-06: 1 reports for this device; peer average 2.49/device 2021-07: 0 reports for this device; peer average 2.34/device 2021-08: 0 reports for this device; peer average 2.29/device 2021-09: 0 reports for this device; peer average 2.42/device 2021-10: 0 reports for this device; peer average 2.21/device 2021-11: 4 reports for this device; peer average 2.09/device 2021-12: 1 reports for this device; peer average 2.32/device 2022-01: 0 reports for this device; peer average 2.08/device 2022-02: 0 reports for this device; peer average 2.12/device 2022-03: 1 reports for this device; peer average 2.18/device 2022-04: 0 reports for this device; peer average 2.17/device 2022-05: 2 reports for this device; peer average 2.14/device 2022-06: 1 reports for this device; peer average 2.24/device 2022-07: 1 reports for this device; peer average 2.12/device 2022-08: 0 reports for this device; peer average 2.22/device 2022-09: 0 reports for this device; peer average 2.22/device 2022-10: 1 reports for this device; peer average 2.18/device 2022-11: 0 reports for this device; peer average 2.27/device 2022-12: 0 reports for this device; peer average 2.18/device 2023-01: 0 reports for this device; peer average 2.27/device 2023-02: 0 reports for this device; peer average 2.16/device 2023-03: 0 reports for this device; peer average 2.36/device 2023-04: 0 reports for this device; peer average 2.31/device 2023-05: 0 reports for this device; peer average 2.24/device 2023-06: 0 reports for this device; peer average 2.34/device 2023-07: 0 reports for this device; peer average 2.21/device 2023-08: 0 reports for this device; peer average 2.06/device 2023-09: 0 reports for this device; peer average 2.07/device 2023-10: 0 reports for this device; peer average 1.72/device 2023-11: 0 reports for this device; peer average 1.68/device 2023-12: 0 reports for this device; peer average 1.77/device 2024-01: 1 reports for this device; peer average 1.78/device 2024-02: 0 reports for this device; peer average 2.1/device 2024-03: 0 reports for this device; peer average 2.05/device 2024-04: 1 reports for this device; peer average 1.84/device 2024-05: 0 reports for this device; peer average 2.25/device 2024-06: 0 reports for this device; peer average 2.03/device 2024-07: 0 reports for this device; peer average 1.78/device 2024-08: 0 reports for this device; peer average 2.01/device 2024-09: 0 reports for this device; peer average 2.12/device 2024-10: 0 reports for this device; peer average 1.84/device 2024-11: 1 reports for this device; peer average 1.77/device 2024-12: 0 reports for this device; peer average 1.61/device 2025-01: 0 reports for this device; peer average 1.94/device 2025-02: 0 reports for this device; peer average 1.56/device 2025-03: 0 reports for this device; peer average 1.78/device 2025-04: 0 reports for this device; peer average 1.83/device 2025-05: 0 reports for this device; peer average 1.73/device 2025-06: 0 reports for this device; peer average 1.85/device 2025-07: 0 reports for this device; peer average 1.83/device 2025-08: 0 reports for this device; peer average 1.73/device 2025-09: 0 reports for this device; peer average 1.75/device 2025-10: 0 reports for this device; peer average 1.73/device 2025-11: 0 reports for this device; peer average 1.81/device 2025-12: 0 reports for this device; peer average 1.9/device 2026-01: 0 reports for this device; peer average 1.98/device 2026-02: 0 reports for this device; peer average 1.68/device 2026-03: 0 reports for this device; peer average 2.01/device 2026-04: 0 reports for this device; peer average 1.89/device 2026-05: 0 reports for this device; peer average 1.75/device 2026-06: 0 reports for this device; peer average 1.79/device 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 Monthly adverse-event reports for this device versus the product-code average. Month This device (reports) Product-code average (reports per device) 2019-01 0 2.99 2019-02 2 2.56 2019-03 1 2.88 2019-04 0 2.72 2019-05 1 2.13 2019-06 0 1.85 2019-07 0 1.85 2019-08 4 2.16 2019-09 2 2.36 2019-10 1 2.57 2019-11 0 2.16 2019-12 1 2.45 2020-01 0 2.81 2020-02 1 2.54 2020-03 0 3.24 2020-04 0 2.27 2020-05 0 2.22 2020-06 1 2.06 2020-07 0 2.55 2020-08 1 2.03 2020-09 2 2.53 2020-10 2 2.53 2020-11 1 2.31 2020-12 2 2.32 2021-01 2 2.44 2021-02 0 2.05 2021-03 0 2.05 2021-04 2 2.07 2021-05 0 1.99 2021-06 1 2.49 2021-07 0 2.34 2021-08 0 2.29 2021-09 0 2.42 2021-10 0 2.21 2021-11 4 2.09 2021-12 1 2.32 2022-01 0 2.08 2022-02 0 2.12 2022-03 1 2.18 2022-04 0 2.17 2022-05 2 2.14 2022-06 1 2.24 2022-07 1 2.12 2022-08 0 2.22 2022-09 0 2.22 2022-10 1 2.18 2022-11 0 2.27 2022-12 0 2.18 2023-01 0 2.27 2023-02 0 2.16 2023-03 0 2.36 2023-04 0 2.31 2023-05 0 2.24 2023-06 0 2.34 2023-07 0 2.21 2023-08 0 2.06 2023-09 0 2.07 2023-10 0 1.72 2023-11 0 1.68 2023-12 0 1.77 2024-01 1 1.78 2024-02 0 2.1 2024-03 0 2.05 2024-04 1 1.84 2024-05 0 2.25 2024-06 0 2.03 2024-07 0 1.78 2024-08 0 2.01 2024-09 0 2.12 2024-10 0 1.84 2024-11 1 1.77 2024-12 0 1.61 2025-01 0 1.94 2025-02 0 1.56 2025-03 0 1.78 2025-04 0 1.83 2025-05 0 1.73 2025-06 0 1.85 2025-07 0 1.83 2025-08 0 1.73 2025-09 0 1.75 2025-10 0 1.73 2025-11 0 1.81 2025-12 0 1.9 2026-01 0 1.98 2026-02 0 1.68 2026-03 0 2.01 2026-04 0 1.89 2026-05 0 1.75 2026-06 0 1.79
This device (reports/month) Average device in JDI, LPH, LWJ, LZO, MEH (reports/device/month)Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2024-11-27 0002249697-2024-01649 Injury Available exact di 2024-04-17 0002249697-2024-00614 Injury Available exact di 2024-01-04 0002249697-2024-00020 Injury Available exact di 2022-10-06 0002249697-2022-01450 Injury Available exact di 2022-07-01 0002249697-2022-00958 Injury Available exact di 2022-06-20 0002249697-2022-00870 Injury Available exact di 2022-05-26 0002249697-2022-00771 Injury Available exact di 2022-05-06 0002249697-2022-00649 Injury Available exact di 2022-03-09 0002249697-2022-00360 Injury Available exact di 2021-12-17 0002249697-2021-02060 Injury Available exact di 2021-11-26 0002249697-2021-01966 Injury Available exact di 2021-11-16 0002249697-2021-01903 Injury Available exact di 2021-11-15 0002249697-2021-01895 Injury Available exact di 2021-11-15 0002249697-2021-01894 Injury Available exact di 2021-06-08 0002249697-2021-00983 Injury Available exact di
Showing 1–15 of 41 ‹ Prev Next ›
Manufacturer compliance record
Date Type Outcome Facility Citations 2023-12-01 VAI Voluntary action indicated Howmedica Osteonics Corp. 1 2021-06-22 NAI No action indicated Howmedica Osteonics Corp. 0 2015-03-09 VAI Voluntary action indicated Howmedica Osteonics Corp. 3 2013-04-16 VAI Voluntary action indicated Howmedica Osteonics Corp. 3 2010-01-15 NAI No action indicated Howmedica Osteonics Corp. 0
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