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ASPHERE
Model 1365-51-100 · DEPUY (IRELAND) · DI 10603295033929
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) · Class III · 21 CFR 888.3330
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
UDILibrary device dossier · generated 2026-09-12 · 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 (25)
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: 25
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
3.63
2019-02
1
3.01
2019-03
3
3.39
2019-04
2
3.12
2019-05
0
2.44
2019-06
0
2.07
2019-07
0
2.15
2019-08
0
2.35
2019-09
1
2.85
2019-10
1
3.06
2019-11
0
2.4
2019-12
1
2.8
2020-01
1
3.15
2020-02
0
2.87
2020-03
1
3.68
2020-04
0
2.51
2020-05
0
2.51
2020-06
0
2.26
2020-07
0
2.78
2020-08
0
2.21
2020-09
0
2.81
2020-10
0
2.78
2020-11
1
2.56
2020-12
0
2.53
2021-01
0
2.69
2021-02
0
2.23
2021-03
0
2.21
2021-04
1
2.25
2021-05
0
2.14
2021-06
0
2.78
2021-07
0
2.51
2021-08
0
2.45
2021-09
2
2.5
2021-10
0
2.3
2021-11
0
2.29
2021-12
0
2.63
2022-01
0
2.25
2022-02
0
2.23
2022-03
0
2.37
2022-04
1
2.34
2022-05
0
2.19
2022-06
2
2.47
2022-07
0
2.22
2022-08
0
2.32
2022-09
1
2.28
2022-10
0
2.25
2022-11
0
2.36
2022-12
0
2.39
2023-01
0
2.3
2023-02
0
2.29
2023-03
0
2.61
2023-04
0
2.41
2023-05
0
2.37
2023-06
0
2.44
2023-07
1
2.21
2023-08
0
2.14
2023-09
0
2.14
2023-10
0
1.78
2023-11
0
1.72
2023-12
0
1.82
2024-01
0
1.82
2024-02
0
2.19
2024-03
0
2.04
2024-04
0
1.83
2024-05
0
2.15
2024-06
0
2
2024-07
0
1.82
2024-08
0
1.9
2024-09
1
2.16
2024-10
0
1.86
2024-11
0
1.81
2024-12
0
1.61
2025-01
0
2
2025-02
0
1.57
2025-03
0
1.81
2025-04
0
1.86
2025-05
0
1.75
2025-06
0
1.88
2025-07
0
1.88
2025-08
0
1.71
2025-09
0
1.86
2025-10
0
1.76
2025-11
0
1.87
2025-12
0
1.97
2026-01
0
2.1
2026-02
0
1.69
2026-03
0
2.08
2026-04
0
1.9
2026-05
0
1.78
2026-06
0
1.8
This device (reports/month)Average device in JDI, KWA, LPH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K082585 — cited as predicate by K120599
Lineage extracted from public 510(k) summary text (heuristic).