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Model 6260-9-336 · Howmedica Osteonics Corp. · DI 07613327032321

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390

LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (47)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

Injury: 47

12232019-01: 2 reports for this device; peer average 2.58/device2019-02: 0 reports for this device; peer average 2.2/device2019-03: 0 reports for this device; peer average 2.34/device2019-04: 2 reports for this device; peer average 2.33/device2019-05: 1 reports for this device; peer average 1.91/device2019-06: 0 reports for this device; peer average 1.65/device2019-07: 1 reports for this device; peer average 1.73/device2019-08: 0 reports for this device; peer average 1.9/device2019-09: 1 reports for this device; peer average 1.97/device2019-10: 1 reports for this device; peer average 2.11/device2019-11: 1 reports for this device; peer average 1.69/device2019-12: 3 reports for this device; peer average 1.96/device2020-01: 0 reports for this device; peer average 2.17/device2020-02: 0 reports for this device; peer average 2.16/device2020-03: 2 reports for this device; peer average 2.7/device2020-04: 0 reports for this device; peer average 1.87/device2020-05: 0 reports for this device; peer average 1.97/device2020-06: 0 reports for this device; peer average 1.7/device2020-07: 1 reports for this device; peer average 2.13/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 1.84/device2020-10: 1 reports for this device; peer average 1.97/device2020-11: 0 reports for this device; peer average 1.88/device2020-12: 2 reports for this device; peer average 1.94/device2021-01: 1 reports for this device; peer average 1.98/device2021-02: 0 reports for this device; peer average 1.7/device2021-03: 1 reports for this device; peer average 1.76/device2021-04: 0 reports for this device; peer average 1.66/device2021-05: 2 reports for this device; peer average 1.64/device2021-06: 1 reports for this device; peer average 2.05/device2021-07: 1 reports for this device; peer average 1.88/device2021-08: 2 reports for this device; peer average 1.77/device2021-09: 1 reports for this device; peer average 1.9/device2021-10: 0 reports for this device; peer average 1.8/device2021-11: 0 reports for this device; peer average 1.76/device2021-12: 0 reports for this device; peer average 1.95/device2022-01: 2 reports for this device; peer average 1.64/device2022-02: 0 reports for this device; peer average 1.94/device2022-03: 0 reports for this device; peer average 1.68/device2022-04: 1 reports for this device; peer average 1.85/device2022-05: 0 reports for this device; peer average 1.75/device2022-06: 3 reports for this device; peer average 1.8/device2022-07: 0 reports for this device; peer average 1.77/device2022-08: 0 reports for this device; peer average 1.9/device2022-09: 0 reports for this device; peer average 1.84/device2022-10: 0 reports for this device; peer average 1.78/device2022-11: 0 reports for this device; peer average 1.88/device2022-12: 1 reports for this device; peer average 1.73/device2023-01: 0 reports for this device; peer average 1.93/device2023-02: 0 reports for this device; peer average 1.75/device2023-03: 1 reports for this device; peer average 1.8/device2023-04: 0 reports for this device; peer average 1.86/device2023-05: 1 reports for this device; peer average 1.89/device2023-06: 0 reports for this device; peer average 1.94/device2023-07: 0 reports for this device; peer average 1.96/device2023-08: 0 reports for this device; peer average 1.91/device2023-09: 0 reports for this device; peer average 1.94/device2023-10: 0 reports for this device; peer average 1.48/device2023-11: 2 reports for this device; peer average 1.48/device2023-12: 0 reports for this device; peer average 1.51/device2024-01: 0 reports for this device; peer average 1.61/device2024-02: 0 reports for this device; peer average 1.74/device2024-03: 0 reports for this device; peer average 1.95/device2024-04: 0 reports for this device; peer average 1.62/device2024-05: 0 reports for this device; peer average 2.09/device2024-06: 1 reports for this device; peer average 1.85/device2024-07: 1 reports for this device; peer average 1.61/device2024-08: 0 reports for this device; peer average 1.84/device2024-09: 0 reports for this device; peer average 1.93/device2024-10: 0 reports for this device; peer average 1.6/device2024-11: 0 reports for this device; peer average 1.44/device2024-12: 1 reports for this device; peer average 1.46/device2025-01: 2 reports for this device; peer average 1.52/device2025-02: 1 reports for this device; peer average 1.38/device2025-03: 0 reports for this device; peer average 1.67/device2025-04: 0 reports for this device; peer average 1.69/device2025-05: 0 reports for this device; peer average 1.39/device2025-06: 0 reports for this device; peer average 1.63/device2025-07: 0 reports for this device; peer average 1.65/device2025-08: 1 reports for this device; peer average 1.44/device2025-09: 0 reports for this device; peer average 1.63/device2025-10: 0 reports for this device; peer average 1.64/device2025-11: 0 reports for this device; peer average 1.7/device2025-12: 0 reports for this device; peer average 1.69/device2026-01: 0 reports for this device; peer average 1.84/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 1 reports for this device; peer average 1.91/device2026-04: 0 reports for this device; peer average 1.65/device2026-05: 1 reports for this device; peer average 1.59/device2026-06: 0 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)
2019-0122.58
2019-0202.2
2019-0302.34
2019-0422.33
2019-0511.91
2019-0601.65
2019-0711.73
2019-0801.9
2019-0911.97
2019-1012.11
2019-1111.69
2019-1231.96
2020-0102.17
2020-0202.16
2020-0322.7
2020-0401.87
2020-0501.97
2020-0601.7
2020-0712.13
2020-0801.63
2020-0901.84
2020-1011.97
2020-1101.88
2020-1221.94
2021-0111.98
2021-0201.7
2021-0311.76
2021-0401.66
2021-0521.64
2021-0612.05
2021-0711.88
2021-0821.77
2021-0911.9
2021-1001.8
2021-1101.76
2021-1201.95
2022-0121.64
2022-0201.94
2022-0301.68
2022-0411.85
2022-0501.75
2022-0631.8
2022-0701.77
2022-0801.9
2022-0901.84
2022-1001.78
2022-1101.88
2022-1211.73
2023-0101.93
2023-0201.75
2023-0311.8
2023-0401.86
2023-0511.89
2023-0601.94
2023-0701.96
2023-0801.91
2023-0901.94
2023-1001.48
2023-1121.48
2023-1201.51
2024-0101.61
2024-0201.74
2024-0301.95
2024-0401.62
2024-0502.09
2024-0611.85
2024-0711.61
2024-0801.84
2024-0901.93
2024-1001.6
2024-1101.44
2024-1211.46
2025-0121.52
2025-0211.38
2025-0301.67
2025-0401.69
2025-0501.39
2025-0601.63
2025-0701.65
2025-0811.44
2025-0901.63
2025-1001.64
2025-1101.7
2025-1201.69
2026-0101.84
2026-0201.46
2026-0311.91
2026-0401.65
2026-0511.59
2026-0601.56
This device (reports/month)Average device in JDI, KWY, LWJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Howmedica Osteonics Corp.

  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • NAI 2021-06-22 Howmedica Osteonics Corp. · 0 citations
  • VAI 2015-03-09 Howmedica Osteonics Corp. · 3 citations
  • VAI 2013-04-16 Howmedica Osteonics Corp. · 3 citations
  • NAI 2010-01-15 Howmedica Osteonics Corp. · 0 citations