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Model 38PF1044 · Microport Orthopedics Inc. · DI M68438PF10441

KXA — Prosthesis, Hip, Femoral, Resurfacing · Class II · 21 CFR 888.3400

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 (3)

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: 3

23562019-03: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 6/device2019-12: 0 reports for this device; peer average 1/device2020-02: 3 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3/device2022-02: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 3.5/device2022-10: 0 reports for this device; peer average 4.5/device2024-04: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 2/device0307091202070810111202040508090205100406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0703
2019-0906
2019-1201
2020-0233
2020-0702.5
2020-0802
2020-1003
2020-1103
2020-1203
2021-0203
2021-0402
2021-0503
2021-0803
2021-0903
2022-0203
2022-0503.5
2022-1004.5
2024-0403
2026-0602
This device (reports/month)Average device in KXA (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