CONSERVE® 38AM4604Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M68438AM46041), received between Mar 23, 2020 and Aug 29, 2022 — classified as 4 injuries.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, ON OR AROUND (B)(6), 2009, PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY (THA) ON HER LEFT SIDE AT (B)(6). HOWEVER, BY THE LATER PART OF THE YEAR 2020, PATIENT'S LEFT HIP HAD BECOME PAINFUL. IN EARLY 2021, ORTHOPEDIC SURGEON INFORMED HER THAT HE BELIEVED THAT HER LEFT HIP HAD FAILED DUE TO ITS METAL-ON-METAL BEARING SURFACE AND NEEDED TO BE REPLACED. ON (B)(6) 2021, PATIENT'S CONSERVE® HIP SYSTEM WAS REVISED AT (B)(6). DURING THE REVISION OF PATIENT'S HIP, SURGEON NOTED THERE WAS GROSS EVIDENCE OF METALLOSIS THROUGHOUT THE HIP. SURGEON WAS ABLE TO EXPLANT THE PROFEMUR TL STEM WITHOUT PERFORMING AN EXTENDED TROCHANTERIC OSTEOTOMY. IN THE (B)(6), 2021, REVISION HIP SURGERY, ALL OF THE WRIGHT MEDICAL HIP DEVICES THAT HAD BEEN IMPLANTED ON (B)(6), 2009, WERE REMOVED AND REPLACED WITH ARTIFICIAL HIP DEVICES MANUFACTURED BY BIOMET-ZIMMER.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15316449 ↗
• InjuryJul 13, 2021Corroded; Corroded

  ALLEGEDLY, PATIENT REVISED DUE TO CORROSION AT THE BALL-NECK JUNCTION, ELEVATED COBALT ION LEVELS, THE PRESENCE OF WHITE CLOUDY JOINT FLUID, AS WELL AS OSTEOLYSIS OF THE PROXIMAL FEMUR AND AMORPHOUS TANNISH TISSUE. (RIGHT HIP).

  Patient problems: Fluid Discharge; Metal Related Pathology; Osteolysis

  MAUDE report 12159035 ↗
• InjuryJan 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT EXPERIENCED PAIN IN HIS HIP AND TESTING REVEALED HIGH COBALT LEVELS THAT COULD LEAD TO COBALT POISONING.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11139166 ↗
• InjuryMar 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, FOR UNKNOWN REASONS PATIENT RECEIVED A REVISION, SHE SUFFERED PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, HIGH LEVELS OF TOXIC METAL LEVELS, CONSCIOUS PAIN AND SUFFERING AND LOSS OF EARNINGS RESULTING FROM THE USE OF THE METAL-ON-METAL WRIGHT HIP SYSTEM. ON 2006 PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT AND RECEIVED A METAL ON METAL WRIGHT HIP SYSTEM ORTHOPAEDIC IMPLANT.

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

  MAUDE report 9868389 ↗