CONSERVE® 38031044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684380310441), received between Dec 31, 2020 and Oct 5, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Output Problem” (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.

• InjuryOct 5, 2022Output Problem

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL HIP RESURFACING IN TWO SEPARATE SURGERIES IN 2018. PATIENT HAS RECENTLY CONTACTED THE HOSPITAL WITH, COMPLAINT OF EXTREMELY HIGH BLOOD LEVELS OF COBALT (200NMOL/L) AND CHROMIUM (300NMOL/L) WHEREAS THE NORMAL LEVEL FOR A PERSON WITH AN IMPLANT IS SUPPOSED TO BE LESS THAN OR EQUAL TO 5NMOL/L. THE PATIENT HAS BEEN SUFFERING FROM WORSENING TINNITUS, INSOMNIA, FATIGUE, HAIR LOSS, ANXIETY AND SKIN ISSUES. THE PATIENT IS ALSO WELL AWARE OF THE DAMAGE TO THE INTERNAL ORGANS DUE TO SUCH TOXIC LEVELS OF THESE METALS IN THE BLOOD. THE SURGERIES WERE PERFORMED BY A CANADIAN SURGEON WHO USED TO BE RESIDENT IN DUBAI FOR MORE THAN 15 YEARS. THERE HAS NOT BEEN INDICATED WHICH PATIENT SIDE IS CAUSING THE PATIENT TO HAVE THESE ISSUES. NO REVISION SURGERY HAS YET BEEN INDICATED. LEFT-SIDED IMPLANTED DEVICES ARE CAPTURED UNDER MICROPORT ORTHOPEDICS REFERENCE NUMBER: (B)(4).

  Patient problems: Hair Loss; Metal Related Pathology

  MAUDE report 15544086 ↗
• InjuryOct 5, 2022Output Problem

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL HIP RESURFACING IN TWO SEPARATE SURGERIES IN 2018. PATIENT HAS RECENTLY CONTACTED THE HOSPITAL WITH, COMPLAINT OF EXTREMELY HIGH BLOOD LEVELS OF COBALT (200NMOL/L) AND CHROMIUM (300NMOL/L) WHEREAS THE NORMAL LEVEL FOR A PERSON WITH AN IMPLANT IS SUPPOSED TO BE LESS THAN OR EQUAL TO 5NMOL/L. THE PATIENT HAS BEEN SUFFERING FROM WORSENING TINNITUS, INSOMNIA, FATIGUE, HAIR LOSS, ANXIETY AND SKIN ISSUES. THE PATIENT IS ALSO WELL AWARE OF THE DAMAGE TO THE INTERNAL ORGANS DUE TO SUCH TOXIC LEVELS OF THESE METALS IN THE BLOOD. THE SURGERIES WERE PERFORMED BY A CANADIAN SURGEON WHO USED TO BE RESIDENT IN DUBAI FOR MORE THAN 15 YEARS. THERE HAS NOT BEEN INDICATED WHICH PATIENT SIDE IS CAUSING THE PATIENT TO HAVE THESE ISSUES. NO REVISION SURGERY HAS YET BEEN INDICATED. RIGHT-SIDED IMPLANTED DEVICES ARE CAPTURED UNDER MICROPORT ORTHOPEDICS REFERENCE NUMBER: (B)(4).

  Patient problems: Hair Loss; Metal Related Pathology

  MAUDE report 15543389 ↗
• InjuryMay 5, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNEXPLAINED PAIN/. ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P1 - FIT AND HEALTHY. COMPONENT NOT REVISED: CONSERVE® THIN SHELL HA COATED 44MM ID 50MM OD BEADED PRODUCT ID: 38HA4450 LOT NO.: 125283320. MHRA REFERENCE NO: (B)(4).

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11776297 ↗
• InjuryApr 15, 2021Fracture

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE? STEM. REVISION NJR NUMBER: (B)(6). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11675143 ↗
• InjuryFeb 3, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING STEM; PAIN; ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS REVISION NJR NUMBER: 4564870 SIDE:L PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING MHRA REFERENCE NO: 2021/002/003/601/007

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11272820 ↗
• InjuryDec 31, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING SOCKET; LYSIS SOCKET. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(4).

  Patient problems: Osteolysis

  MAUDE report 11100371 ↗