Print-ready dossier — use your browser's print dialog to save as PDF.
3DMetal Tibial Cones
Model 02.07.CS25 · Medacta International SA · DI 07630030884085
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
UDILibrary device dossier · generated 2026-09-06 · 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
2.03
2019-02
0
2.07
2019-03
0
1.68
2019-04
0
2.01
2019-05
0
1.83
2019-06
0
2.19
2019-07
0
2.04
2019-08
0
2.24
2019-09
0
2.01
2019-10
0
2.44
2019-11
0
3.01
2019-12
0
2.42
2020-01
0
2.39
2020-02
0
2.82
2020-03
0
2.28
2020-04
0
2.21
2020-05
0
1.83
2020-06
0
2.09
2020-07
0
2.66
2020-08
0
2.72
2020-09
0
2.23
2020-10
0
2.94
2020-11
0
2.86
2020-12
0
2.95
2021-01
0
2.47
2021-02
0
2.45
2021-03
0
2.59
2021-04
0
2.45
2021-05
0
2.36
2021-06
0
2.18
2021-07
0
2.24
2021-08
0
1.88
2021-09
0
2.33
2021-10
0
1.96
2021-11
0
2.31
2021-12
0
2.33
2022-01
0
2.03
2022-02
0
2.38
2022-03
0
2.05
2022-04
0
2.1
2022-05
0
2.33
2022-06
0
2.03
2022-07
0
2.06
2022-08
0
2.1
2022-09
0
2.28
2022-10
0
2.2
2022-11
0
2.24
2022-12
0
1.9
2023-01
0
2.09
2023-02
0
2.23
2023-03
0
2.23
2023-04
0
2.26
2023-05
0
2.41
2023-06
0
2.26
2023-07
0
2
2023-08
0
1.71
2023-09
0
1.76
2023-10
0
1.63
2023-11
0
1.68
2023-12
0
1.7
2024-01
0
1.57
2024-02
0
1.74
2024-03
0
1.78
2024-04
0
1.64
2024-05
0
1.91
2024-06
0
1.98
2024-07
0
1.85
2024-08
0
2.31
2024-09
0
2
2024-10
0
1.99
2024-11
0
2
2024-12
0
2.09
2025-01
0
2.32
2025-02
0
1.83
2025-03
0
1.86
2025-04
0
1.66
2025-05
0
1.71
2025-06
0
1.81
2025-07
0
1.62
2025-08
0
1.63
2025-09
0
1.64
2025-10
0
1.43
2025-11
0
1.7
2025-12
0
1.66
2026-01
0
1.55
2026-02
0
1.53
2026-03
0
1.99
2026-04
0
1.75
2026-05
0
1.71
2026-06
0
1.7
This device (reports/month)Average device in JWH (reports/device/month)