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"""PROFEMUR®"

Model APA07568 · Microport Orthopedics Inc. · DI M684APA075681

HWT — Template · Class I · 21 CFR 888.4800

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 (0)

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.

11232019-01: 0 reports for this device; peer average 1.42/device2019-02: 0 reports for this device; peer average 1.95/device2019-03: 0 reports for this device; peer average 1.69/device2019-04: 0 reports for this device; peer average 1.65/device2019-05: 0 reports for this device; peer average 2.3/device2019-06: 0 reports for this device; peer average 1.42/device2019-07: 0 reports for this device; peer average 1.54/device2019-08: 0 reports for this device; peer average 1.4/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 2.57/device2019-11: 0 reports for this device; peer average 1.7/device2019-12: 0 reports for this device; peer average 1.85/device2020-01: 0 reports for this device; peer average 1.76/device2020-02: 0 reports for this device; peer average 1.57/device2020-03: 0 reports for this device; peer average 1.63/device2020-04: 0 reports for this device; peer average 1.63/device2020-05: 0 reports for this device; peer average 1.39/device2020-06: 0 reports for this device; peer average 1.68/device2020-07: 0 reports for this device; peer average 1.8/device2020-08: 0 reports for this device; peer average 1.87/device2020-09: 0 reports for this device; peer average 1.64/device2020-10: 0 reports for this device; peer average 1.89/device2020-11: 0 reports for this device; peer average 1.76/device2020-12: 0 reports for this device; peer average 1.67/device2021-01: 0 reports for this device; peer average 1.55/device2021-02: 0 reports for this device; peer average 2.15/device2021-03: 0 reports for this device; peer average 1.9/device2021-04: 0 reports for this device; peer average 1.9/device2021-05: 0 reports for this device; peer average 1.79/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.08/device2021-08: 0 reports for this device; peer average 1.61/device2021-09: 0 reports for this device; peer average 2.13/device2021-10: 0 reports for this device; peer average 1.77/device2021-11: 0 reports for this device; peer average 1.62/device2021-12: 0 reports for this device; peer average 1.83/device2022-01: 0 reports for this device; peer average 1.52/device2022-02: 0 reports for this device; peer average 1.75/device2022-03: 0 reports for this device; peer average 2.05/device2022-04: 0 reports for this device; peer average 1.56/device2022-05: 0 reports for this device; peer average 1.28/device2022-06: 0 reports for this device; peer average 1.82/device2022-07: 0 reports for this device; peer average 2.66/device2022-08: 0 reports for this device; peer average 1.65/device2022-09: 0 reports for this device; peer average 1.64/device2022-10: 0 reports for this device; peer average 2.93/device2022-11: 0 reports for this device; peer average 1.49/device2022-12: 0 reports for this device; peer average 1.92/device2023-01: 0 reports for this device; peer average 2.32/device2023-02: 0 reports for this device; peer average 2.02/device2023-03: 0 reports for this device; peer average 2.17/device2023-04: 0 reports for this device; peer average 1.99/device2023-05: 0 reports for this device; peer average 1.84/device2023-06: 0 reports for this device; peer average 1.6/device2023-07: 0 reports for this device; peer average 1.92/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 0 reports for this device; peer average 1.34/device2023-10: 0 reports for this device; peer average 1.52/device2023-11: 0 reports for this device; peer average 2.24/device2023-12: 0 reports for this device; peer average 1.51/device2024-01: 0 reports for this device; peer average 1.88/device2024-02: 0 reports for this device; peer average 2.09/device2024-03: 0 reports for this device; peer average 1.65/device2024-04: 0 reports for this device; peer average 1.51/device2024-05: 0 reports for this device; peer average 1.85/device2024-06: 0 reports for this device; peer average 1.91/device2024-07: 0 reports for this device; peer average 1.76/device2024-08: 0 reports for this device; peer average 1.58/device2024-09: 0 reports for this device; peer average 1.56/device2024-10: 0 reports for this device; peer average 1.85/device2024-11: 0 reports for this device; peer average 1.98/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.57/device2025-02: 0 reports for this device; peer average 1.44/device2025-03: 0 reports for this device; peer average 1.52/device2025-04: 0 reports for this device; peer average 1.51/device2025-05: 0 reports for this device; peer average 1.74/device2025-06: 0 reports for this device; peer average 1.79/device2025-07: 0 reports for this device; peer average 1.78/device2025-08: 0 reports for this device; peer average 1.47/device2025-09: 0 reports for this device; peer average 1.43/device2025-10: 0 reports for this device; peer average 2.44/device2025-11: 0 reports for this device; peer average 2.85/device2025-12: 0 reports for this device; peer average 2.03/device2026-01: 0 reports for this device; peer average 1.92/device2026-02: 0 reports for this device; peer average 2.13/device2026-03: 0 reports for this device; peer average 1.69/device2026-04: 0 reports for this device; peer average 1.89/device2026-05: 0 reports for this device; peer average 1.71/device2026-06: 0 reports for this device; peer average 1.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.42
2019-0201.95
2019-0301.69
2019-0401.65
2019-0502.3
2019-0601.42
2019-0701.54
2019-0801.4
2019-0901.5
2019-1002.57
2019-1101.7
2019-1201.85
2020-0101.76
2020-0201.57
2020-0301.63
2020-0401.63
2020-0501.39
2020-0601.68
2020-0701.8
2020-0801.87
2020-0901.64
2020-1001.89
2020-1101.76
2020-1201.67
2021-0101.55
2021-0202.15
2021-0301.9
2021-0401.9
2021-0501.79
2021-0602
2021-0702.08
2021-0801.61
2021-0902.13
2021-1001.77
2021-1101.62
2021-1201.83
2022-0101.52
2022-0201.75
2022-0302.05
2022-0401.56
2022-0501.28
2022-0601.82
2022-0702.66
2022-0801.65
2022-0901.64
2022-1002.93
2022-1101.49
2022-1201.92
2023-0102.32
2023-0202.02
2023-0302.17
2023-0401.99
2023-0501.84
2023-0601.6
2023-0701.92
2023-0801.73
2023-0901.34
2023-1001.52
2023-1102.24
2023-1201.51
2024-0101.88
2024-0202.09
2024-0301.65
2024-0401.51
2024-0501.85
2024-0601.91
2024-0701.76
2024-0801.58
2024-0901.56
2024-1001.85
2024-1101.98
2024-1201.62
2025-0101.57
2025-0201.44
2025-0301.52
2025-0401.51
2025-0501.74
2025-0601.79
2025-0701.78
2025-0801.47
2025-0901.43
2025-1002.44
2025-1102.85
2025-1202.03
2026-0101.92
2026-0202.13
2026-0301.69
2026-0401.89
2026-0501.71
2026-0601.85
This device (reports/month)Average device in HWT (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