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PROFEMUR®

Model PHAC1254 · Microport Orthopedics Inc. · DI M684PHAC12541

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

MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous · Class II · 21 CFR 888.3358

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 (67)

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: 66 · Malfunction: 1

24572019-01: 0 reports for this device; peer average 3.21/device2019-02: 0 reports for this device; peer average 2.72/device2019-03: 0 reports for this device; peer average 3.16/device2019-04: 0 reports for this device; peer average 2.94/device2019-05: 0 reports for this device; peer average 2.27/device2019-06: 4 reports for this device; peer average 1.93/device2019-07: 1 reports for this device; peer average 1.91/device2019-08: 1 reports for this device; peer average 2.27/device2019-09: 0 reports for this device; peer average 2.56/device2019-10: 1 reports for this device; peer average 2.84/device2019-11: 0 reports for this device; peer average 2.4/device2019-12: 0 reports for this device; peer average 2.72/device2020-01: 4 reports for this device; peer average 3.16/device2020-02: 2 reports for this device; peer average 2.71/device2020-03: 1 reports for this device; peer average 3.49/device2020-04: 0 reports for this device; peer average 2.46/device2020-05: 1 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 2.3/device2020-07: 1 reports for this device; peer average 2.75/device2020-08: 1 reports for this device; peer average 2.2/device2020-09: 3 reports for this device; peer average 2.83/device2020-10: 3 reports for this device; peer average 2.82/device2020-11: 1 reports for this device; peer average 2.54/device2020-12: 0 reports for this device; peer average 2.56/device2021-01: 1 reports for this device; peer average 2.73/device2021-02: 2 reports for this device; peer average 2.26/device2021-03: 3 reports for this device; peer average 2.26/device2021-04: 1 reports for this device; peer average 2.28/device2021-05: 0 reports for this device; peer average 2.18/device2021-06: 1 reports for this device; peer average 2.73/device2021-07: 2 reports for this device; peer average 2.62/device2021-08: 0 reports for this device; peer average 2.65/device2021-09: 1 reports for this device; peer average 2.73/device2021-10: 0 reports for this device; peer average 2.45/device2021-11: 0 reports for this device; peer average 2.27/device2021-12: 7 reports for this device; peer average 2.57/device2022-01: 1 reports for this device; peer average 2.32/device2022-02: 1 reports for this device; peer average 2.21/device2022-03: 1 reports for this device; peer average 2.49/device2022-04: 0 reports for this device; peer average 2.33/device2022-05: 0 reports for this device; peer average 2.36/device2022-06: 4 reports for this device; peer average 2.48/device2022-07: 1 reports for this device; peer average 2.3/device2022-08: 0 reports for this device; peer average 2.37/device2022-09: 0 reports for this device; peer average 2.41/device2022-10: 1 reports for this device; peer average 2.38/device2022-11: 0 reports for this device; peer average 2.47/device2022-12: 0 reports for this device; peer average 2.51/device2023-01: 1 reports for this device; peer average 2.59/device2023-02: 0 reports for this device; peer average 2.44/device2023-03: 0 reports for this device; peer average 2.71/device2023-04: 1 reports for this device; peer average 2.51/device2023-05: 1 reports for this device; peer average 2.4/device2023-06: 3 reports for this device; peer average 2.47/device2023-07: 0 reports for this device; peer average 2.3/device2023-08: 1 reports for this device; peer average 2.09/device2023-09: 0 reports for this device; peer average 2.07/device2023-10: 1 reports for this device; peer average 1.83/device2023-11: 1 reports for this device; peer average 1.77/device2023-12: 0 reports for this device; peer average 1.9/device2024-01: 0 reports for this device; peer average 1.87/device2024-02: 2 reports for this device; peer average 2.23/device2024-03: 1 reports for this device; peer average 2.02/device2024-04: 0 reports for this device; peer average 1.89/device2024-05: 1 reports for this device; peer average 2.18/device2024-06: 0 reports for this device; peer average 2.02/device2024-07: 0 reports for this device; peer average 1.84/device2024-08: 0 reports for this device; peer average 1.99/device2024-09: 2 reports for this device; peer average 2.17/device2024-10: 0 reports for this device; peer average 1.93/device2024-11: 0 reports for this device; peer average 1.97/device2024-12: 0 reports for this device; peer average 1.68/device2025-01: 0 reports for this device; peer average 2.14/device2025-02: 0 reports for this device; peer average 1.64/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.92/device2025-05: 0 reports for this device; peer average 1.91/device2025-06: 0 reports for this device; peer average 1.95/device2025-07: 0 reports for this device; peer average 1.95/device2025-08: 0 reports for this device; peer average 1.89/device2025-09: 0 reports for this device; peer average 1.81/device2025-10: 0 reports for this device; peer average 1.83/device2025-11: 0 reports for this device; peer average 1.86/device2025-12: 0 reports for this device; peer average 1.99/device2026-01: 0 reports for this device; peer average 2.05/device2026-02: 1 reports for this device; peer average 1.77/device2026-03: 0 reports for this device; peer average 1.98/device2026-04: 0 reports for this device; peer average 2.01/device2026-05: 0 reports for this device; peer average 1.81/device2026-06: 0 reports for this device; peer average 1.86/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.21
2019-0202.72
2019-0303.16
2019-0402.94
2019-0502.27
2019-0641.93
2019-0711.91
2019-0812.27
2019-0902.56
2019-1012.84
2019-1102.4
2019-1202.72
2020-0143.16
2020-0222.71
2020-0313.49
2020-0402.46
2020-0512.36
2020-0602.3
2020-0712.75
2020-0812.2
2020-0932.83
2020-1032.82
2020-1112.54
2020-1202.56
2021-0112.73
2021-0222.26
2021-0332.26
2021-0412.28
2021-0502.18
2021-0612.73
2021-0722.62
2021-0802.65
2021-0912.73
2021-1002.45
2021-1102.27
2021-1272.57
2022-0112.32
2022-0212.21
2022-0312.49
2022-0402.33
2022-0502.36
2022-0642.48
2022-0712.3
2022-0802.37
2022-0902.41
2022-1012.38
2022-1102.47
2022-1202.51
2023-0112.59
2023-0202.44
2023-0302.71
2023-0412.51
2023-0512.4
2023-0632.47
2023-0702.3
2023-0812.09
2023-0902.07
2023-1011.83
2023-1111.77
2023-1201.9
2024-0101.87
2024-0222.23
2024-0312.02
2024-0401.89
2024-0512.18
2024-0602.02
2024-0701.84
2024-0801.99
2024-0922.17
2024-1001.93
2024-1101.97
2024-1201.68
2025-0102.14
2025-0201.64
2025-0301.86
2025-0401.92
2025-0501.91
2025-0601.95
2025-0701.95
2025-0801.89
2025-0901.81
2025-1001.83
2025-1101.86
2025-1201.99
2026-0102.05
2026-0211.77
2026-0301.98
2026-0402.01
2026-0501.81
2026-0601.86
This device (reports/month)Average device in LPH, LZO, MBL (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