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.
49 linked reports Injury 49
1 3 4 5 2019-01: 1 reports for this device; peer average 2.99/device 2019-02: 5 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: 3 reports for this device; peer average 2.13/device 2019-06: 2 reports for this device; peer average 1.85/device 2019-07: 1 reports for this device; peer average 1.85/device 2019-08: 2 reports for this device; peer average 2.16/device 2019-09: 2 reports for this device; peer average 2.36/device 2019-10: 2 reports for this device; peer average 2.57/device 2019-11: 1 reports for this device; peer average 2.16/device 2019-12: 0 reports for this device; peer average 2.45/device 2020-01: 1 reports for this device; peer average 2.81/device 2020-02: 0 reports for this device; peer average 2.54/device 2020-03: 0 reports for this device; peer average 3.24/device 2020-04: 1 reports for this device; peer average 2.27/device 2020-05: 2 reports for this device; peer average 2.22/device 2020-06: 2 reports for this device; peer average 2.06/device 2020-07: 1 reports for this device; peer average 2.55/device 2020-08: 1 reports for this device; peer average 2.03/device 2020-09: 0 reports for this device; peer average 2.53/device 2020-10: 4 reports for this device; peer average 2.53/device 2020-11: 1 reports for this device; peer average 2.31/device 2020-12: 0 reports for this device; peer average 2.32/device 2021-01: 0 reports for this device; peer average 2.44/device 2021-02: 2 reports for this device; peer average 2.05/device 2021-03: 1 reports for this device; peer average 2.05/device 2021-04: 0 reports for this device; peer average 2.07/device 2021-05: 1 reports for this device; peer average 1.99/device 2021-06: 0 reports for this device; peer average 2.49/device 2021-07: 1 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: 0 reports for this device; peer average 2.09/device 2021-12: 0 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: 3 reports for this device; peer average 2.18/device 2022-04: 0 reports for this device; peer average 2.17/device 2022-05: 0 reports for this device; peer average 2.14/device 2022-06: 0 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: 1 reports for this device; peer average 2.22/device 2022-10: 0 reports for this device; peer average 2.18/device 2022-11: 3 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: 1 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: 0 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: 0 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: 0 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: 1 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: 1 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 1 2.99 2019-02 5 2.56 2019-03 1 2.88 2019-04 0 2.72 2019-05 3 2.13 2019-06 2 1.85 2019-07 1 1.85 2019-08 2 2.16 2019-09 2 2.36 2019-10 2 2.57 2019-11 1 2.16 2019-12 0 2.45 2020-01 1 2.81 2020-02 0 2.54 2020-03 0 3.24 2020-04 1 2.27 2020-05 2 2.22 2020-06 2 2.06 2020-07 1 2.55 2020-08 1 2.03 2020-09 0 2.53 2020-10 4 2.53 2020-11 1 2.31 2020-12 0 2.32 2021-01 0 2.44 2021-02 2 2.05 2021-03 1 2.05 2021-04 0 2.07 2021-05 1 1.99 2021-06 0 2.49 2021-07 1 2.34 2021-08 0 2.29 2021-09 0 2.42 2021-10 0 2.21 2021-11 0 2.09 2021-12 0 2.32 2022-01 0 2.08 2022-02 0 2.12 2022-03 3 2.18 2022-04 0 2.17 2022-05 0 2.14 2022-06 0 2.24 2022-07 1 2.12 2022-08 0 2.22 2022-09 1 2.22 2022-10 0 2.18 2022-11 3 2.27 2022-12 0 2.18 2023-01 0 2.27 2023-02 1 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 0 1.78 2024-02 0 2.1 2024-03 0 2.05 2024-04 0 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 0 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 1 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 1 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 2026-02-09 0002249697-2026-00083 Injury Available exact di 2025-05-20 0002249697-2025-00526 Injury Available exact di 2023-02-15 0002249697-2023-00159 Injury Available exact di 2022-11-24 0002249697-2022-01727 Injury Available exact di 2022-11-18 0002249697-2022-01662 Injury Available exact di 2022-11-04 0002249697-2022-01583 Injury Available exact di 2022-09-12 0002249697-2022-01326 Injury Available exact di 2022-07-13 0002249697-2022-01004 Injury Available exact di 2022-03-23 0002249697-2022-00423 Injury Available exact di 2022-03-07 0002249697-2022-00334 Injury Available exact di 2022-03-01 0002249697-2022-00290 Injury Available exact di 2021-07-06 0002249697-2021-01139 Injury Available exact di 2021-05-06 0002249697-2021-00806 Injury Available exact di 2021-03-04 0002249697-2021-00376 Injury Available exact di 2021-02-26 0002249697-2021-00349 Injury Available exact di
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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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