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CONSERVE® 38AM5400Recalls & reported problems

Microport Orthopedics Inc. · CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 54MM · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M68438AM54001), received between Mar 4, 2020 and Apr 13, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1
  • Material Disintegration1

Patient problems

  • Loss of Range of Motion1
  • Metal Related Pathology1
  • Pain1
  • Reaction1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 13, 2022Material Disintegration; Material Disintegration

    (B)(4). ALLEGEDLY, PX BEGAN TO EXPERIENCE PAIN, DECREASED MOBILITY, METAL DEBRIS, LOOSENING OF THE ACETABULUM AND METALLOSIS.

    Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

    MAUDE report 14103939 ↗
  • InjuryMar 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO LEFT HIP ADVERSE LOCAL TISSUE REACTION.

    Patient problems: Reaction

    MAUDE report 9787668 ↗

Other Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) devices

All Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.