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Trinity Acetabular Hip System with ECiMa Liners
Model 322.03.636 · CORIN LTD · DI 05055343869550
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
OQI — Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented · Class II · 21 CFR 888.3353
UDILibrary device dossier · generated 2026-09-15 · 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 (28)
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: 28
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
2.37
2019-02
0
2.17
2019-03
0
2.43
2019-04
0
2.4
2019-05
0
1.91
2019-06
0
1.67
2019-07
0
1.62
2019-08
0
1.98
2019-09
0
1.93
2019-10
0
2.17
2019-11
0
2
2019-12
0
2.2
2020-01
0
2.54
2020-02
0
2.19
2020-03
0
2.75
2020-04
0
2.07
2020-05
0
1.95
2020-06
0
1.87
2020-07
0
2.3
2020-08
0
1.94
2020-09
0
2.4
2020-10
0
2.35
2020-11
0
2.09
2020-12
0
2.15
2021-01
0
2.22
2021-02
0
1.92
2021-03
0
1.93
2021-04
0
1.93
2021-05
0
1.94
2021-06
0
2.21
2021-07
0
2.22
2021-08
0
2.17
2021-09
0
2.43
2021-10
0
2.16
2021-11
0
1.97
2021-12
0
2.09
2022-01
0
1.98
2022-02
0
1.99
2022-03
0
2.04
2022-04
0
2.02
2022-05
0
2.16
2022-06
0
2.06
2022-07
0
2.04
2022-08
0
2.06
2022-09
0
2.13
2022-10
0
2.09
2022-11
0
2.17
2022-12
0
2.03
2023-01
0
2.18
2023-02
0
2.01
2023-03
0
2.15
2023-04
1
2.2
2023-05
0
2.07
2023-06
0
2.18
2023-07
1
2.1
2023-08
3
1.88
2023-09
1
1.91
2023-10
3
1.64
2023-11
0
1.61
2023-12
0
1.71
2024-01
0
1.72
2024-02
0
1.99
2024-03
0
1.95
2024-04
1
1.79
2024-05
2
2.17
2024-06
0
1.93
2024-07
0
1.71
2024-08
0
1.99
2024-09
0
1.93
2024-10
2
1.77
2024-11
1
1.76
2024-12
0
1.59
2025-01
1
1.94
2025-02
0
1.56
2025-03
0
1.75
2025-04
0
1.8
2025-05
0
1.75
2025-06
4
1.84
2025-07
2
1.77
2025-08
0
1.75
2025-09
2
1.66
2025-10
0
1.7
2025-11
0
1.78
2025-12
0
1.9
2026-01
2
1.87
2026-02
0
1.69
2026-03
0
1.92
2026-04
0
1.96
2026-05
0
1.75
2026-06
2
1.77
This device (reports/month)Average device in LZO, MEH, OQI (reports/device/month)