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TRANSCEND®
Model 26000026 · Microport Orthopedics Inc. · DI M684260000261
JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) · Class III · 21 CFR 888.3320
KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) · Class III · 21 CFR 888.3330
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 (30)
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: 30
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
4.85
2019-02
0
3.81
2019-03
0
4.74
2019-04
0
3.37
2019-05
3
3.42
2019-06
0
2.95
2019-07
0
2.91
2019-08
0
2.95
2019-09
0
3.5
2019-10
0
4.54
2019-11
0
2.57
2019-12
0
3.73
2020-01
3
2.89
2020-02
0
2.8
2020-03
0
3.42
2020-04
0
2.69
2020-05
0
2.61
2020-06
0
1.86
2020-07
3
2.29
2020-08
0
2.53
2020-09
0
3.7
2020-10
0
2.18
2020-11
0
2.77
2020-12
0
2.85
2021-01
0
2.95
2021-02
0
2.8
2021-03
0
2.08
2021-04
0
2.43
2021-05
0
2
2021-06
0
2.63
2021-07
0
3.2
2021-08
0
2.71
2021-09
0
2.5
2021-10
0
2.37
2021-11
0
1.83
2021-12
0
3.71
2022-01
0
2.55
2022-02
0
1.73
2022-03
0
2.59
2022-04
0
2.1
2022-05
0
2.47
2022-06
0
2.48
2022-07
0
1.95
2022-08
0
1.9
2022-09
0
2.4
2022-10
0
1.43
2022-11
0
1.71
2022-12
0
2.1
2023-01
0
2.36
2023-02
0
2.03
2023-03
3
3
2023-04
0
2.64
2023-05
0
2.08
2023-06
0
3.11
2023-07
0
1.78
2023-08
0
2.16
2023-09
3
3.18
2023-10
0
2.35
2023-11
0
2.19
2023-12
0
2.55
2024-01
0
2.07
2024-02
6
3.43
2024-03
0
1.64
2024-04
0
1.93
2024-05
0
1.86
2024-06
6
1.9
2024-07
0
1.9
2024-08
0
1.31
2024-09
0
1.64
2024-10
0
1.8
2024-11
0
1.9
2024-12
0
1.78
2025-01
0
2.64
2025-02
0
1.9
2025-03
0
2.39
2025-04
0
2.23
2025-05
0
2.08
2025-06
0
2.1
2025-07
0
2.17
2025-08
0
1.63
2025-09
3
2.05
2025-10
0
1.63
2025-11
0
1.76
2025-12
0
2.44
2026-01
0
2.68
2026-02
0
2.03
2026-03
0
2.18
2026-04
0
1.94
2026-05
0
1.68
2026-06
0
1.95
This device (reports/month)Average device in JDL, KWA (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