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CONSERVE® 38031046Recalls & reported problems

Microport Orthopedics Inc. · CONSERVE® FEMORAL RESURFACING HEAD 46MM · Class 2 · Implant

Adverse event reports
5
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684380310461), received between Sep 11, 2019 and May 11, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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

  • Insufficient Device Problem Information3
  • Loss of Osseointegration1
  • Particulates1

Patient problems

  • Reaction2
  • Insufficient Information1
  • Metal Related Pathology1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMay 11, 2022Loss of Osseointegration; Loss of Osseointegration

    ALLEGEDLY, PATIENT WAS REVISED DUE TO LOOSENING STEM. REVISION NJR NUMBER: (B)(4), SIDE:L, PRIMARY ASA: P1 - FIT AND HEALTHY.

    Patient problems: Insufficient Information

    MAUDE report 14361408 ↗
  • InjuryMay 10, 2022Particulates

    ALLEGEDLY, PATIENT WAS REVISED DUE TO UNEXPLAINED PAIN/ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 14348900 ↗
  • InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4432449. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Unspecified Infection

    MAUDE report 10339187 ↗
  • MalfunctionSep 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN; PERIPROSTHETIC FRACTURE STEM; ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. REVISION (B)(4). SIDE:R: PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: CONSERVE® THIN SHELL HA COATED 46MM ID 52MM OD BEADED (B)(4).

    Patient problems: Reaction

    MAUDE report 8996420 ↗
  • MalfunctionSep 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN; PERIPROSTHETIC FRACTURE STEM; ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. REVISION (B)(4). SIDE:R: PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: CONSERVE® THIN SHELL HA COATED 46MM ID 52MM OD BEADED (B)(4).

    Patient problems: Reaction

    MAUDE report 8996413 ↗

Other Prosthesis, Hip, Femoral, Resurfacing devices

All Prosthesis, Hip, Femoral, Resurfacing devices →

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