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CONSERVE® 38031048Recalls & reported problems

Microport Orthopedics Inc. · CONSERVE® FEMORAL RESURFACING HEAD 48MM · Class 2 · Implant

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684380310481), received between Jul 29, 2020 and Oct 18, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Disintegration” (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

  • Material Disintegration2
  • Patient-Device Incompatibility2
  • Appropriate Device Problem Term/Code Not Available1
  • Corroded1
  • Insufficient Device Problem Information1
  • Particulates1

Patient problems

  • Metal Related Pathology3
  • Pain2
  • Reaction2
  • Osteolysis1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 18, 2022Particulates; Patient-Device Incompatibility

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

    Patient problems: Metal Related Pathology

    MAUDE report 15627125 ↗
  • InjuryFeb 23, 2022Appropriate Device Problem Term/Code Not Available

    ALLEGEDLY, PATIENT WAS REVISED DUE TO LYSIS - STEM/LYSIS - SOCKET/WEAR OF ACETABULAR COMPONENT. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: MILD DISEASE NOT INCAPACITATING. THERE IS NO PHYSICAL STEM IMPLANTED.

    Patient problems: Osteolysis

    MAUDE report 13587965 ↗
  • InjurySep 9, 2021Material Disintegration; Material Disintegration

    ALLEGEDLY, PATIENT WAS REVISED DUE TO 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

    MAUDE report 12448182 ↗
  • InjuryMay 12, 2021Patient-Device Incompatibility

    ALLEGEDLY, THE PATIENT UNDERWENT LEFT HIP RESURFACING ARTHROPLASTY IN 2017. THEN WAS REVISED DUE TO PAIN, ADVERSE TISSUE REACTION AND ELEVATED ION LEVELS. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON 05/05/2021: PRODUCT ID AND LOT INFORMATION.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 11815455 ↗
  • InjuryOct 12, 2020Corroded; Material Disintegration; Corroded; Material Disintegration

    ALLEGEDLY, REVISION SURGERY REQUIRED. PATIENT PRESENTED PSEUDOTUMOR, ELEVATED METAL ION BLOOD LEVELS, AND PAIN. DEVICE FAILURE ATTRIBUTED TO ADVERSE TISSUE REACTION TO METAL DEBRIS, CORROSION AND RESULTANT METAL IONS. LEFT SIDE.

    Patient problems: Pain; Reaction

    MAUDE report 10667073 ↗
  • InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

    Patient problems: Reaction

    MAUDE report 10338773 ↗

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.