CONSERVE® 38AM5004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M68438AM50041), received between Feb 18, 2020 and May 12, 2022 — classified as 9 injuries.

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PLAINTIFF HAD A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008, ON (B)(6) 2009 PLAINTIFF UNDERWENT A REVISION SURGERY, IN THIS SURGERY, THE CONSERVE PLUS CUP WAS REMOVED AND REPLACED WITH A WRIGHT MEDICAL DYNASTY CUP; THE CONSERVE TOTAL A-CLASS HEADCOBALT-CHROMIUM HEAD WAS REMOVED AND REPLACED WITH A CONSERVE A-CLASS HEAD COBALT-CHROMIUM HEAD. IN ADDITION, THE FOLLOWING WRIGHT MEDICAL HIP COMPONENT DEVICES WERE IMPLANTED DURING THIS SURGERY: ACETABULAR LINER (LOT NO. 039828320); ACETABULAR SHELL (LOT NO.068632095); AND, ANOTHER COMPONENT (LOT NO. 059862510). THE STEM AND NECK WERE NOT INDICATED AS REVISED COMPONENTS. PRODUCT ID: PHA00268 PROFEMUR® Z FEMORAL STEM S 5 1/3 TP COATED CEMENT LESS, LOT: 117488870, QTY: 1. PRODUCT ID: PHA01204 PROFEMUR® NECK NEUTRAL LONG, LOT: 107484845, QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 14377487 ↗
• InjuryMay 12, 2022Output Problem

  ALLEGEDLY, PLAINTIFF HAD A WRIGHT MEDICAL HIP SYSTEM IN THE RIGHT HIP, BY THE YEAR 2021 PLAINTIFF DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS LEFT AND RIGHT HIP JOINTS, AS WELL AS NEUROLOGIC SYMPTOMS INCLUDING PERIPHERAL NEUROPATHY, AND TINNITUS. LABORATORY TEST RESULTS REPORTED IN (B)(6) 2021, REVEALED ELEVATED SERUM CHROMIUM AND BLOOD COBALT LEVELS IN PLAINTIFF. DR. (B)(6) NOTED A PSEUDOTUMOR AND RELATED IT TO METALLOSIS. REMOVE THE WRIGHT MEDICAL COMPONENTS, INCLUDING THE PROFEMUR® HIP SYSTEM, INCLUDING THE PROFEMUR® PLUS COCR MODULAR NECK AND THE PROFEMUR® PLASMA Z STEM. DR. (B)(6) ALSO INFORMED PLAINTIFF THAT IT WOULD BE MEDICALLY NECESSARY TO REMOVE AND REPLACE THE CONSERVE® FEMORAL HEAD AND DYNASTY CUP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14375815 ↗
• InjuryFeb 23, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENTS METAL IONS WERE HIGH SO SURGEON WANTED TO REMOVE THE MOM ARTICULATION. REPORTER CONFIRMED THAT ONLY THE HEAD WAS REMOVED. THE OTHER DEVICES WERE NOT REVISED: 38025056 CONSERVE® PLUS CUP 50MM ID 56MM OD BEADED , LOT: 076351420, QTY:1. PHA00272 PROFEMUR® PLASMA Z STEM SIZE 7 , LOT: 086357552, QTY:1. PHA01204 PROFEMUR® NECK NEUTRAL LONG LOT: 086367283, QTY:1.

  Patient problems: Metal Related Pathology

  MAUDE report 13586586 ↗
• InjuryJul 7, 2021Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL DEBRIS, CORROSION BETWEEN THE ARTICULATING SURFACES AS WELL AS RESULTANT METAL IONS.

  Patient problems: Metal Related Pathology

  MAUDE report 12132671 ↗
• InjuryApr 27, 2021Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL DEBRIS, CORROSION AND METAL IONS.

  Patient problems: Metal Related Pathology

  MAUDE report 11731234 ↗
• InjuryMar 29, 2021Therapeutic or Diagnostic Output Failure

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO FAILURE OF THE MODULAR NECK AT THE NECK/STEM JUNCTION TAPER (FRACTURED NECK). THE REVISION OPERATIVE NOTES ALSO LISTS, "MODERATE METALLOSIS (NO PSEUDOTUMOR)" AS AN INTRAOPERATIVE FINDING.

  Patient problems: Metal Related Pathology

  MAUDE report 11585808 ↗
• InjuryAug 13, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ACETABULAR COMPONENT LOOSENING , METALLOSIS WITH PROBABLE ADVERSE TISSUE REACTION AND ELEVATED IONS LEVELS OF HIS LEFT HIP.

  Patient problems: Reaction

  MAUDE report 10402151 ↗
• InjuryJul 13, 2020Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS OF HIS RIGHT HIP.

  Patient problems: Reaction

  MAUDE report 10268427 ↗
• InjuryFeb 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE LOCAL TISSUE REACTION. ADDITIONAL INFORMATION: RIGHT HIP.

  Patient problems: Metal Related Pathology; Reaction

  MAUDE report 9722062 ↗