CONSERVE® 38AM4400Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M68438AM44001), received between Jul 29, 2019 and Sep 26, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Disintegration” (4 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.

• InjurySep 26, 2024Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO PAIN AND CORROSIVE BLACK MATERIAL AT THE HEAD NECK STEM AND NECK STEM TAPER JUNCTIONS. METALLIC STAINING AS WELL AS GROSS NECROTIC TISSUE DEBRIS WITHIN THE JOINT.

  Patient problems: Pain

  MAUDE report 20313391 ↗
• InjuryJan 26, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT STARTED TO EXPERIENCE PAIN IN OR AROUND HIS RIGHT HIP JOINT, ALONG WITH COBALT AND CHROMIUM LEVELS THAT WERE INCREASING OVER THE PAST FEW YEARS. CONTINUING AND INCREASING PAIN IN HIS RIGHT HIP, AND ELEVATED SERUM COBALT/CHROMIUM LEVELS REPORTED ON JULY 22, 2019. IN (B)(6) 2019, RIGHT HIP REVISION PROCEDURE PATIENT´S RIGHT HIP WAS REVISED, RESULTING IN REMOVAL AND REPLACEMENT OF THE PREVIOUSLY IMPLANTED CONSERVE-DYNASTY-PROFEMUR HIP SYSTEM METAL-ON-METAL BEARING SURFACE WITH A BIOMET DUAL MOBILITY ACTIVE ARTICULATION HIP SYSTEM, AND A MICROPORT ALUMINA MATRIC COMPOSITE DELTA OPTION HEAD, AND A DELTA OPTION NECK SLEEVE. AN OPERATIVE NOTE FROM (B)(6) 2019, REVISION PROCEDURE REFERENCES A FINDING OF STAINED SYNOVIUM AND SIGNIFICANT CORROSION ON THE MODULAR NECK. THE EXTRACTED MODULAR NECK SHOWS SIGNIFICANT CORROSION ON BOTH THE PROXIMAL AND DISTAL TRUNNIONS OF THAT DEVICE. DUE TO CONCERNS WITH A HISTORY OF THE WRIGHT MEDICAL TITANIUM PROFEMUR MODULAR NECKS CORRODING, AND FRACTURING, THE INTRA-OPERATIVE MEDICAL DECISION WAS ALSO MADE BY SURGEON TO REMOVE AND REPLACE THE TITANIUM PROFEMUR MODULAR NECK OF THAT HIP WITH A NEW, NOT YET CORRODING, TITANIUM MODULAR NECK.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 13357702 ↗
• InjuryJun 3, 2021Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, PATIENT SUFFERED PAIN DUE TO METAL ON METAL COMPLICATIONS INCLUDING LOOSENING OF THE CUP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11932700 ↗
• InjuryMay 5, 2021Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, THE PATIENT WAS REVISED CORROSION AT THE NECK-STEM JUNCTION, ADVERSE LOCAL TISSUE REACTION AND METAL DEBRIS.

  Patient problems: Metal Related Pathology

  MAUDE report 11779744 ↗
• InjuryJan 5, 2021Malposition of Device

  ALLEGEDLY, CUP WAS IMPROPERLY POSITIONED. LEG LENGTH DIFFERENCE. OUR NECK AND HEAD CAME OUT ALONG W/THE SHELL (W/O CUP CUTTERS). TJO CUP, SCREWS (2), LINER AND HEAD USED WITH OUR NECK. CULTURES TAKEN. BMI 24.8 RIGHT HIP. COMPONENT NOT REVISED: PYRD0004 PROFEMUR RAZ STEM LOT 067426983.

  Patient problems: Unequal Limb Length

  MAUDE report 11116209 ↗
• InjuryAug 13, 2020Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, PATIENT REVISED DUE TO METAL DEBRIS, CORROSION, PSEUDOTUMORS AND RESULTANT METAL IONS. ADDITIONAL INFORMATION: RIGHT HIP. COMPONENTS WERE REMOVED, INCLUDING THE METAL LINER AND METAL FEMORAL HEAD, THE SHELL AND STEM WERE RETAINED. ADDITIONAL INFORMATION RECEIVED ON 07/20/2020: ADDING PRODUCT NUMBERS AND LOT ID'S.

  Patient problems: Reaction

  MAUDE report 10401735 ↗
• InjuryApr 1, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT AND RECEIVED A MOM WRIGHT HIP SYSTEM IMPLANTS. PATIENT SUFFERED PAIN, DEBILITATING LACK OF MOBILITY, HIGH LEVELS OF TOXIC METAL LEVELS, CONSCIOUS PAIN AND SUFFERING AND LOSS OF EARNINGS.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9913188 ↗
• InjuryDec 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, MOM CASE. NON-MPO CUP, LINER AND SCREWS WENT IN, AND OUR HEAD AND NECK WERE USED (MPO). COMPONENTS NOT REVISED: PROFEMUR PLASMA Z STEM SZ3: PHA0-0264; LOT NUMBER: 117496065. CULTURES TAKEN, LEFT HIP.

  Patient problems: Reaction

  MAUDE report 9535676 ↗
• InjuryJul 29, 2019Material Disintegration; Noise, Audible; Migration; Material Disintegration; Noise, Audible; Migration

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: SEVERE HIP PAIN; ELEVATED METAL LEVELS OF COBALT AND CHROMIUM; EVIDENCE OF SUBSIDENCE OF THE STEM; METALLOSIS; AND CLICKING (RIGHT).

  Patient problems: Pain

  MAUDE report 8838383 ↗