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Trident X3 Insert
Model 723-00-36D · Howmedica Osteonics Corp. · DI 07613327296990
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWL — Prosthesis, Hip, Hemi-, Femoral, Metal · Class II · 21 CFR 888.3360
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
UDILibrary device dossier · generated 2026-09-16 · 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 (45)
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: 43 · Malfunction: 2
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
2.72
2019-02
0
2.35
2019-03
0
2.65
2019-04
0
2.54
2019-05
0
2.03
2019-06
0
1.73
2019-07
0
1.74
2019-08
0
2.02
2019-09
0
2.16
2019-10
0
2.35
2019-11
0
1.99
2019-12
0
2.25
2020-01
0
2.56
2020-02
0
2.32
2020-03
0
2.91
2020-04
0
2.08
2020-05
0
2.04
2020-06
0
1.91
2020-07
0
2.34
2020-08
0
1.87
2020-09
0
2.3
2020-10
0
2.28
2020-11
0
2.12
2020-12
0
2.16
2021-01
0
2.26
2021-02
0
1.9
2021-03
0
1.91
2021-04
0
1.91
2021-05
0
1.86
2021-06
0
2.31
2021-07
0
2.15
2021-08
2
2.1
2021-09
0
2.23
2021-10
0
2.06
2021-11
0
1.91
2021-12
0
2.12
2022-01
0
1.91
2022-02
0
1.94
2022-03
1
1.99
2022-04
2
2.01
2022-05
0
2
2022-06
0
2.06
2022-07
1
1.95
2022-08
0
2.02
2022-09
0
2.05
2022-10
2
2
2022-11
0
2.08
2022-12
2
1.99
2023-01
0
2.13
2023-02
0
1.97
2023-03
0
2.15
2023-04
0
2.11
2023-05
3
2.05
2023-06
1
2.11
2023-07
1
2.02
2023-08
1
1.9
2023-09
0
1.92
2023-10
0
1.6
2023-11
0
1.56
2023-12
1
1.65
2024-01
2
1.68
2024-02
0
1.95
2024-03
1
1.92
2024-04
1
1.71
2024-05
0
2.03
2024-06
0
1.87
2024-07
2
1.68
2024-08
0
1.86
2024-09
0
1.95
2024-10
2
1.74
2024-11
1
1.65
2024-12
0
1.53
2025-01
0
1.81
2025-02
3
1.48
2025-03
0
1.76
2025-04
1
1.77
2025-05
0
1.63
2025-06
2
1.78
2025-07
2
1.78
2025-08
0
1.62
2025-09
1
1.67
2025-10
0
1.68
2025-11
0
1.73
2025-12
0
1.81
2026-01
2
1.9
2026-02
2
1.58
2026-03
1
1.88
2026-04
1
1.81
2026-05
1
1.61
2026-06
3
1.69
This device (reports/month)Average device in JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MEH (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