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PROCOTYL
Model PHA04406 · Microport Orthopedics Inc. · DI M684PHA044061
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
UDILibrary device dossier · generated 2026-09-11 · 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 (36)
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: 36
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
3.32
2019-02
0
2.85
2019-03
0
3.29
2019-04
0
3.04
2019-05
0
2.32
2019-06
3
2
2019-07
3
1.96
2019-08
0
2.36
2019-09
0
2.66
2019-10
0
2.96
2019-11
0
2.47
2019-12
0
2.82
2020-01
0
3.31
2020-02
0
2.83
2020-03
0
3.61
2020-04
0
2.56
2020-05
0
2.44
2020-06
0
2.36
2020-07
9
2.82
2020-08
0
2.3
2020-09
0
2.95
2020-10
0
2.92
2020-11
0
2.64
2020-12
0
2.63
2021-01
0
2.79
2021-02
3
2.32
2021-03
0
2.31
2021-04
0
2.35
2021-05
0
2.23
2021-06
0
2.8
2021-07
0
2.65
2021-08
0
2.71
2021-09
0
2.78
2021-10
0
2.48
2021-11
0
2.34
2021-12
3
2.62
2022-01
3
2.39
2022-02
0
2.25
2022-03
0
2.54
2022-04
0
2.4
2022-05
0
2.42
2022-06
0
2.54
2022-07
0
2.37
2022-08
0
2.43
2022-09
0
2.47
2022-10
0
2.44
2022-11
3
2.52
2022-12
0
2.56
2023-01
0
2.65
2023-02
0
2.47
2023-03
0
2.74
2023-04
0
2.58
2023-05
0
2.46
2023-06
0
2.54
2023-07
0
2.32
2023-08
0
2.11
2023-09
0
2.09
2023-10
0
1.86
2023-11
0
1.79
2023-12
0
1.91
2024-01
0
1.89
2024-02
6
2.28
2024-03
0
2.07
2024-04
0
1.92
2024-05
0
2.2
2024-06
0
2.04
2024-07
0
1.86
2024-08
0
2.02
2024-09
0
2.19
2024-10
0
1.94
2024-11
0
2
2024-12
0
1.69
2025-01
0
2.18
2025-02
3
1.66
2025-03
0
1.88
2025-04
0
1.93
2025-05
0
1.93
2025-06
0
1.97
2025-07
0
1.96
2025-08
0
1.9
2025-09
0
1.82
2025-10
0
1.83
2025-11
0
1.88
2025-12
0
2
2026-01
0
2.06
2026-02
0
1.78
2026-03
0
2.01
2026-04
0
2.03
2026-05
0
1.84
2026-06
0
1.87
This device (reports/month)Average device in LPH, LZO (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