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Trident
Model 623-10-36E · Howmedica Osteonics Corp. · DI 07613327039917
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
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 2026-09-14 · 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 (41)
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: 40 · Malfunction: 1
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)
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