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Profemur
Model PHA01254 · Microport Orthopedics Inc. · DI M684PHA012541
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
MRA — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented · Class III
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 (102)
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: 99 · Malfunction: 3
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
3.3
2019-02
0
2.87
2019-03
0
3.14
2019-04
0
3.04
2019-05
2
2.18
2019-06
2
1.9
2019-07
0
1.93
2019-08
2
2.5
2019-09
4
2.39
2019-10
8
2.99
2019-11
0
2.43
2019-12
3
2.67
2020-01
0
3.26
2020-02
3
3.36
2020-03
6
3.87
2020-04
3
2.46
2020-05
1
2.45
2020-06
0
2.2
2020-07
0
3.09
2020-08
3
2.39
2020-09
6
2.95
2020-10
0
2.86
2020-11
3
2.54
2020-12
3
3.02
2021-01
0
2.81
2021-02
0
2.68
2021-03
3
2.63
2021-04
0
2.66
2021-05
0
2.3
2021-06
0
3.32
2021-07
6
3.33
2021-08
0
3.18
2021-09
0
3.13
2021-10
0
2.79
2021-11
0
2.47
2021-12
0
2.7
2022-01
0
2.37
2022-02
6
2.61
2022-03
0
3.01
2022-04
3
2.69
2022-05
0
2.78
2022-06
0
2.79
2022-07
0
2.94
2022-08
3
3.11
2022-09
0
2.97
2022-10
0
3.16
2022-11
0
2.83
2022-12
0
2.95
2023-01
0
3.46
2023-02
2
3
2023-03
0
3.15
2023-04
0
3.03
2023-05
0
3.01
2023-06
3
3.27
2023-07
0
3.02
2023-08
0
2.9
2023-09
0
2.88
2023-10
3
2.35
2023-11
3
2.42
2023-12
0
2.67
2024-01
0
2.49
2024-02
0
2.6
2024-03
3
2.64
2024-04
0
2.36
2024-05
0
3.45
2024-06
6
2.87
2024-07
0
2.39
2024-08
0
2.92
2024-09
0
3.17
2024-10
0
2.58
2024-11
0
2.41
2024-12
0
2.15
2025-01
0
2.41
2025-02
2
1.82
2025-03
0
2.21
2025-04
2
2.48
2025-05
0
2.34
2025-06
2
2.28
2025-07
0
2.49
2025-08
0
2.47
2025-09
0
2.18
2025-10
2
2.31
2025-11
4
2.09
2025-12
0
2.23
2026-01
0
2.25
2026-02
0
2.22
2026-03
0
2.35
2026-04
0
2.34
2026-05
0
2.07
2026-06
0
2.38
This device (reports/month)Average device in LWJ, MRA (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