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BENCOX Bipolar Cup System
Model H2.A51.0039-01 · Corentec Co., Ltd · DI 08806373869303
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
UDILibrary device dossier · generated 2026-09-13 · 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 (0)
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.
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
3.28
2019-02
0
2.81
2019-03
0
3.24
2019-04
0
3.02
2019-05
0
2.32
2019-06
0
1.95
2019-07
0
1.97
2019-08
0
2.25
2019-09
0
2.66
2019-10
0
2.91
2019-11
0
2.35
2019-12
0
2.67
2020-01
0
3.06
2020-02
0
2.67
2020-03
0
3.4
2020-04
0
2.41
2020-05
0
2.28
2020-06
0
2.25
2020-07
0
2.62
2020-08
0
2.1
2020-09
0
2.68
2020-10
0
2.59
2020-11
0
2.48
2020-12
0
2.46
2021-01
0
2.7
2021-02
0
2.12
2021-03
0
2.11
2021-04
0
2.19
2021-05
0
1.99
2021-06
0
2.69
2021-07
0
2.37
2021-08
0
2.47
2021-09
0
2.43
2021-10
0
2.24
2021-11
0
2.14
2021-12
0
2.43
2022-01
0
2.16
2022-02
0
1.94
2022-03
0
2.32
2022-04
0
2.22
2022-05
0
2.13
2022-06
0
2.43
2022-07
0
2.11
2022-08
0
2.24
2022-09
0
2.24
2022-10
0
2.18
2022-11
0
2.24
2022-12
0
2.27
2023-01
0
2.49
2023-02
0
2.28
2023-03
0
2.57
2023-04
0
2.38
2023-05
0
2.26
2023-06
0
2.3
2023-07
0
2.08
2023-08
0
1.96
2023-09
0
1.96
2023-10
0
1.73
2023-11
0
1.63
2023-12
0
1.75
2024-01
0
1.78
2024-02
0
2.13
2024-03
0
1.95
2024-04
0
1.74
2024-05
0
1.92
2024-06
0
1.86
2024-07
0
1.73
2024-08
0
1.8
2024-09
0
2.07
2024-10
0
1.86
2024-11
0
1.79
2024-12
0
1.56
2025-01
0
1.97
2025-02
0
1.53
2025-03
0
1.86
2025-04
0
1.82
2025-05
0
1.74
2025-06
0
1.85
2025-07
0
1.9
2025-08
0
1.71
2025-09
0
1.75
2025-10
0
1.73
2025-11
0
1.76
2025-12
0
1.86
2026-01
0
1.97
2026-02
0
1.6
2026-03
0
1.88
2026-04
0
1.84
2026-05
0
1.57
2026-06
0
1.71
This device (reports/month)Average device in KWY, LPH (reports/device/month)