CONSERVE® 38AM4600Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M68438AM46001), received between Jun 24, 2019 and Feb 1, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, AN MRI OF THE PATIENT'S LEFT HIP TAKEN DUE TO PAIN ON (B)(6) 2021, THIS SHOWED A PERIARTICULAR CYST, SUGGESTIVE OF METALLOSIS. THE METAL ION LEVELS EXTRACTED ON (B)(6) 2022 WERE FOUND TO BE CR = 3.4 AND CO = 3.8 WHICH INCREASED WITH RESPECT TO THE METAL IONS EXTRACTED ON MAY 14, 2021, WHICH WERE CR= 2.2 AND CO= 2.9.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18627704 ↗
• InjuryDec 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, THE HEAD AND THE NECK ON THE LEFT SIDE WERE REVISED DUE TO PAIN. NON EXPLANTED PRODUCTS: PRODUCT ID: PRLX5812 PROFEMUR® LX STEM SZ 12 5/8 PS COATED/ LOT NUMBER: 0711374029/ QTY: 1 PRODUCT ID: 38024652 CONSERVE® THIN SHELL 46MM ID 52MM OD BEADED/ LOT NUMBER: 0611361525/ QTY: 1.

  Patient problems: Pain

  MAUDE report 18387039 ↗
• InjuryDec 22, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL DEBRIS.

  Patient problems: Insufficient Information

  MAUDE report 11059348 ↗
• InjuryMar 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY. THE IMPLANTS GENERATE METAL DEBRIS, CORROSION AND METAL IONS, WHICH CAUSE DANGEROUSLY ELEVATED BLOOD LEVELS OF COCRIONS ADVERSE TISSUE REACTIONS, PSEUDOTUMORS, NECROSIS, BONE LOSS .

  Patient problems: Reaction

  MAUDE report 9882381 ↗
• InjuryDec 10, 2019Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, THE PATIENT HAD PAIN IN HER LEFT HIP, SUBJECT HAS A HISTORY OF ELEVATED COBALT AND CHROMIUM LEVELS. SUBJECT HAS A TOTAL OF FIVE TOTAL JOINTS IN HER BODY, INCLUDING BOTH HIPS. THE PHYSICIAN ORDERED METAL ION TESTING FROM JOINT FLUID FROM BOTH HIPS. NOT ENOUGH FLUID WAS OBTAINED FROM THE RIGHT HIP TO PERFORM TESTING. COBALT AND CHROMIUM METAL IONS WERE PRESENT IN THE LEFT HIP FLUID. UPDATE DECEMBER 5 2019. THE CONSERVE TOTAL A-CLASS FEMORAL HEAD WAS REMOVED. CORROSION OF THE FEMORAL HEAD-NECK/ TRUNNION JUNCTION WAS NOTED. THE MODULAR NECK AND FEMORAL STEM WERE WELL FIXED AND WERE NOT REVISED. THE SUBJECT WAS DISCHARGED THE SAME DAY.

  Patient problems: Pain

  MAUDE report 9444145 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE SHELL APPEARS TO BE LOOSE. CUP WAS CUT OUT AND REPLACED WITH STRYKERS CUP, LINER AND DUAL MOBILITY. OUR 28MM LONG HEAD WAS USED WITH THE DUAL MOBILITY . OUR HEDA CAME OUT (46MM).

  Patient problems: Reaction

  MAUDE report 8838380 ↗
• InjuryJun 26, 2019Material Disintegration; Material Disintegration

  ALLEGEDLY THE PATIENT HAS PREVIOUSLY UNDERWENT A LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2008. SHE WAS PRESENTED WITH LEFT HIP PAIN. HER MRI REVEALS SOME EXTENSIVE MULTI-LOCULATED FLUID COLLECTION. HER SERUM CHROMIUM AND COBALT LEVELS ARE OVER 20. A REVISION TO A TITANIUM FEMORAL NECK WAS RECOMMENDED. SHE HAS A BODY WEIGHT OF (B)(6) POUNDS. REVISION SURGERY IS SET FOR (B)(6) 2019.

  Patient problems: Fluid Discharge; Pain; Reaction

  MAUDE report 8736887 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT SCHEDULED TO BE REVISED DUE TO UNKNOWN COMPLICATIONS.

  Patient problems: No Information

  MAUDE report 8728002 ↗