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ADVANCE®
Model KTCCNP20 · Microport Orthopedics Inc. · DI M684KTCCNP201
HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3530
UDILibrary device dossier · generated 2026-09-07 · 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 (33)
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: 33
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
1.82
2019-02
0
1.86
2019-03
0
1.39
2019-04
0
1.52
2019-05
0
1.58
2019-06
3
1.92
2019-07
0
1.53
2019-08
0
1.52
2019-09
0
1.31
2019-10
0
1.55
2019-11
0
1.45
2019-12
0
2.26
2020-01
0
1.62
2020-02
0
1.86
2020-03
0
2.6
2020-04
0
2.1
2020-05
0
1.47
2020-06
0
3.6
2020-07
0
4.41
2020-08
0
4.34
2020-09
0
3.93
2020-10
3
4.72
2020-11
0
4.75
2020-12
3
7.34
2021-01
0
4.83
2021-02
3
5.1
2021-03
3
2.66
2021-04
0
2.48
2021-05
3
4.68
2021-06
0
4.39
2021-07
0
3.94
2021-08
0
4.34
2021-09
0
5.65
2021-10
0
3.6
2021-11
0
3.87
2021-12
0
4.32
2022-01
3
3.66
2022-02
0
5.3
2022-03
0
4.25
2022-04
0
4.26
2022-05
0
6.4
2022-06
0
3.46
2022-07
0
4.71
2022-08
0
3.46
2022-09
0
3.19
2022-10
0
4.1
2022-11
0
3.72
2022-12
0
4.11
2023-01
0
4.35
2023-02
0
3.31
2023-03
0
2.68
2023-04
6
4.15
2023-05
0
3.17
2023-06
0
3.87
2023-07
0
2.42
2023-08
0
2.5
2023-09
0
1.91
2023-10
0
2.18
2023-11
0
2.84
2023-12
0
2.07
2024-01
3
3.12
2024-02
0
2.46
2024-03
3
2.73
2024-04
0
2.94
2024-05
0
1.95
2024-06
0
2.41
2024-07
0
2.96
2024-08
0
2.81
2024-09
0
2.74
2024-10
0
2.3
2024-11
0
2.11
2024-12
0
3.03
2025-01
0
2.23
2025-02
0
2.2
2025-03
0
2.2
2025-04
0
2.32
2025-05
0
2.29
2025-06
0
1.94
2025-07
0
2.62
2025-08
0
1.88
2025-09
0
2.48
2025-10
0
2.57
2025-11
0
2
2025-12
0
2.58
2026-01
0
1.73
2026-02
0
2.29
2026-03
0
2.41
2026-04
0
2
2026-05
0
2.71
2026-06
0
1.97
This device (reports/month)Average device in HRY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Microport Orthopedics Inc.
Warning Letter 2015-06-17 MicroPort Orthopedics Inc.
Warning Letter 2015-06-17 MicroPort Orthopedics Inc.
NAI 2023-02-08 MicroPort Orthopedics Inc. · 0 citations
NAI 2023-02-08 MicroPort Orthopedics Inc. · 0 citations
VAI 2018-06-29 MicroPort Orthopedics Inc. · 2 citations
VAI 2018-06-29 MicroPort Orthopedics Inc. · 2 citations
VAI 2015-08-19 MicroPort Orthopedics Inc. · 5 citations
VAI 2015-08-19 MicroPort Orthopedics Inc. · 5 citations