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CONSERVE® 38AM4035Recalls & reported problems

Microport Orthopedics Inc. · CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM · Class 3 · Implant

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M68438AM40351), received between Aug 24, 2020 and Apr 12, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Corroded” (2 reports).

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

  • Corroded2
  • Insufficient Device Problem Information2
  • Adverse Event Without Identified Device or Use Problem1
  • Fitting Problem1
  • Material Disintegration1
  • No Apparent Adverse Event1

Patient problems

  • Metal Related Pathology4
  • Pain2
  • Insufficient Information1
  • No Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, ON OR ABOUT (B)(6) 2021, PLAINTIFF REPORTED FOR A REVISION/REPLACEMENT IF THE FEMORAL HEAD AND NECK. DR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH PAIN AND WEAKNESS, ADVERSE LOCAL TISSUE REACTION AND ELEVATED COBALT LEVELS. NECK (PHA01242), HEAD (PHA04426), AND LINER (DLXPLF40) WERE IMPLANTED DURING THE REVISION SURGERY. PRODUCTS NOT REVISED: PRODUCT ID: LOT NUMBER: QTY: 20070031 1830209 1. DSPCGF56 1822203 1. PHA00248 01112839031803042 1. 18080304 1771974 1. 18080303 1802295 1.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 16726770 ↗
  • InjuryDec 1, 2021Fitting Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Fitting Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

    Patient problems: Insufficient Information; Metal Related Pathology

    MAUDE report 12908463 ↗
  • InjuryJun 9, 2021Corroded; Corroded

    ALLEGEDLY, PATIENT SUFFERED PAIN DUE TO CORROSION AND ELEVATED ION LEVELS.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 11966506 ↗
  • InjuryMar 2, 2021Corroded

    ALLEGEDLY, THE SUBJECT WAS REVISED DUE TO METALLOSIS AND CORROSION ALONG THE TAPER.

    Patient problems: Metal Related Pathology

    MAUDE report 11400080 ↗
  • InjuryAug 24, 2020Material Disintegration; Material Disintegration

    ALLEGEDLY, THE X-RAY SHOWED DISLOCATION OF THE ACETABULAR LINER WITH SUPERIOR MIGRATION OF THE FEMORAL HEAD INTO THE ACETABULUM. THE PHYSICIAN FOUND LARGE LOOSE POLY FRAGMENT FLOATING WITHIN THE HIP CAPSULE AS WELL AS SEVERE METALLOSIS. TOTAL HIP COMPONENTS WERE REMOVED.

    Patient problems: No Information

    MAUDE report 10443385 ↗

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.