CONSERVE® 38014400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684380144001), received between May 9, 2016 and Jan 25, 2022 — classified as 6 injuries.

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

• InjuryJan 25, 2022Defective Device; Output Problem

  ALLEGEDLY, THE PLAINTIFF INDICATES THAT THE HIP HAD A UNREASONABLY HIGH RISK OF FAILING IN HER BODY, CAUSING TOXIC LEVELS OF COBALT AND CHROMIC DEBRIS, TISSUE AND BONE DESTRUCTION AND THE NEED FOR THE PLAINTIFF TO UNDERGO SURGERY TO REMOVED AND REPLACE THE DEFECTIVE IMPLANT, ON OR ABOUT (B)(6) 2013 PLAINTIFF'S BLOOD TEST SHOWED THAT THE HIP HAS GIVEN HER HEAVY METAL POISONING.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 13342147 ↗
• InjuryAug 13, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY THE PATIENT WAS EXPERIENCING UNKNOWN MOM COMPLICATIONS . ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 10/01/2019: UPDATING REASON FOR REVISION AND ADDING IMPLANT DATE , EXPLANT DATE , HOSPITAL NAME , DOCTOR NAME , PRODUCTS AND LOT NUMBERS. ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE TISSUE REACTION TO METAL DEBRIS, CORROSION AND RESULTANT METAL IONS.

  Patient problems: Reaction

  MAUDE report 10402389 ↗
• InjuryAug 4, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE METAL-METAL JUNCTION BETWEEN THE COBALT-CHROMIUM MODULAR NECK AND THE TITANIUM STEM AND THE METAL DEBRIS AND ION CAST OFF FROM THE COBALT AND CHROMIUM CONSERVE FEMORAL HEAD AND COBALT AND CHROMIUM DYNASTY LINER. MODULAR NECK WAS REMOVED AND CONSERVE FEMORAL HEAD WAS REPLACED WITH A POLYETHYLENE DUAL FEMORAL HEAD.

  Patient problems: No Information

  MAUDE report 10361756 ↗
• InjuryApr 8, 2020Device-Device Incompatibility; Naturally Worn; Naturally Worn

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS (LEFT HIP). ADDITIONAL INFORMATION RECEIVED ON 7/25/2022: ALLEGEDLY, ON (B)(6) 2007 PATIENT WAS ADMITTED TO THE HOSPITAL OF PIOMBINO. DIAGNOSED WITH LEFT COXARTHROSIS TO UNDERGO SURGERY ON (B)(6) 2007 FOR TOTAL LEFT HIP REPLACEMENT. DISCHARGED ON (B)(6) 2007. AFTER A FEW YEARS, AND MORE PRECISELY AT THE END OF 2015 - BEGINNING OF 2016, THE PATIENT STARTED TO COMPLAIN OF PAIN IN HER LEFT HIP WHICH DID NOT ALLOW HER TO WALK PROPERLY. PATIENT UNDERWENT AN ORTHOPEDIC EXAMINATION WHICH REVEALED AN IMPORTANT PRESENCE IN THE BLOOD OF METALLOSIS, WITH HIGH CONCENTRATIONS OF COBALT AND CHROMIUM AND RELATED INTOXICATION, AND MOREOVER, THE SAME PROBLEM FOR WHICH SHE HAD BEEN OPERATED HAD RECURRED, NAMELY COXALGIA. THE SAME PROSTHESIS PRESENTED SERIOUS WEAR, FROM WHICH THE METALLOSIS IN THE BLOOD WITH CONSEQUENT PHYSICAL DAMAGE AND DISABILITY OF PATIENT. PATIENT WAS AGAIN HOSPITALIZED, FOR THE REASONS MENTIONED ABOVE, AT THE CECINA HOSPITAL, ON (B)(6) 2018, TO UNDERGO A NEW ONE PROSTHESIS REPLACEMENT SURGERY. EXAMINATION FROM DR. VANNI FOUND THAT HIP ARTHROPLASTY SURGERY LEFT, WITH "MOM" PROSTHESIS IMPLANT MADE ON (B)(6) 2007 A

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

  MAUDE report 9939144 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9874290 ↗
• InjuryMay 9, 2016Appropriate Device Problem Term/Code Not Available

  ORIG. SURG. (B)(6) 2006. ALLEGEDLY PT. HAS PAIN. ADD'L INFO REC'D 3-1-2012: ON (B)(6) 2011 DR. (B)(6) REVIEWED PT.'S X-RAYS AND DISCOVERED THE HIPS WERE UNCEMENTED AND THERE WAS A MECHANICAL COMPLICATION. BILATERAL HIPS. SURGERY PERFORMED BY DR. (B)(6) @ (B)(6). ADDITIONAL INFORMATION RECEIVED 04/08/2016. ALLEGEDLY THE PATIENT WAS REVISED DUE TO THE FOLLOWING MOM COMPLICATIONS: METAL HYPERSENSITIVITY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 5639627 ↗