CONSERVE® 38AM4835Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M68438AM48351), received between Mar 10, 2016 and Jun 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT IS EXPERIENCING MOM COMPLICATIONS (LEFT). ADDITIONAL INFORMATION RECEIVED ON 05/22/2024 BY LEGAL DEPARTMENT: ALLEGEDLY, ON (B)(6) 2007 PLAINTIFF HAD AN ARTIFICIAL HIP IMPLANTED IN HIS LEFT HIP IN WHAT IS KNOWN A TOTAL HIP ARTOPLASTY OR "THA". HE WAS IMPLANTED AT CEDARS-SINI MEDICAL CENTER. ON (B)(6) 2014, PLAINTIFF HAD A REVISION OF HIS LEFT HIP TO CONVERT THE BEARING SURFACE FROM MOM BEARING SURFACE TO A METAL-ON-POLY BEARING. THE SURGERY WAS PERFORMED AT (B)(6) THE FEMORAL HEAD WAS REMOVED. HOWEVER, THE MODULAR NECK WAS WELL FIXED IN THE FEMORAL STEM, AND FEMORAL STEM WAS ALSO WELL FIXED, SO THEY WERE LEFT IN PLACE. PRODUCTS IMPLANTED IN FIRST REVISION SURGERY: ZIMMER CTM ACETABULAR COMPONENT 58MM OD, 36MMID POLYETHYLENE LINER WRIGHT 36MM FEMORAL HEAD, +7. MPO NON REVISED PRODUCTS: PRODUCT ID: PHA00242, PROFEMUR® Z FEMORAL STEM S 6 CEMENT LESS, LOT: 096375746, QTY: (B)(4). PRODUCT ID: PHA01212, PROFEMUR® NECK A/R VAR/VAL 2 SHORT, LOT: 106380691, QTY: (B)(4).

  Patient problems: Metal Related Pathology

  MAUDE report 19518900 ↗
• InjuryMar 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, ACCORDING TO DR. PATIENT HAD METAL ALLERGY/HIGH ION COUNT BELIEVED TO BE FROM THE EXISTING METAL HEAD AND METAL CONSERVE CUP. DR. WANTED TO KEEP THE STEM,NECK AND CUP; THEN REPLACE THE HEAD WITH A DELTA OPTION 28 AND DYNASTY DUAL MOBILITY 48MM POLY LINER. DR. UNDERSTOOD THAT THIS WAS OFF-LABEL. DR THINKS THIS WOULD BE LEAST INVASIVE OPTION FOR PATIENT. AFTER RELAYING INFORMATION THAT WE AT CORPORATE, WOULD NOT OFFER THIS IMPLANT, DR. DECIDED TO REMOVE ENTIRE STEM AFTER A GTO. IMPLANTED WAS A DEPUY CORAIL STEM AND A STRYKER 48 DUAL MOBILITY INSERT.

  Patient problems: Metal Related Pathology

  MAUDE report 18888348 ↗
• InjuryFeb 4, 2022Output Problem

  ALLEGEDLY, THE PATIENT IS EXPERIENCING MOM COMPLICATIONS (LEFT). ADDITIONAL INFORMATION RECEIVED ON 01/21/2022. ALLEGEDLY, PATIENT UNDERWENT INDEX SURGERY ON HIS LEFT HIP ON (B)(6) 2010 AT (B)(6) HOSPITAL IN (B)(6). PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY ON HIS LEFT HIP AT (B)(6) HOSPITAL ON (B)(6) 2020. THIS IS AN ALLEGED DYNASTY® MOM CASE.

  Patient problems: Metal Related Pathology

  MAUDE report 13453734 ↗
• 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 RIGHT HIP.

  Patient problems: Reaction

  MAUDE report 10400953 ↗
• InjuryJan 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PAINFUL HIP. REMOVED LINER AND HEAD.

  Patient problems: Pain

  MAUDE report 9602362 ↗
• InjuryMar 10, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED FOR MOM COMPLICATIONS: PAIN; METAL WEAR DEBRIS (LEFT).

  Patient problems: Reaction

  MAUDE report 5493335 ↗