Profemur PHA00264Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684PHA002641), received between Feb 26, 2020 and May 12, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Corroded” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT HAD CORROSION OF THE PROFEMUR® PLUS COCR MODULAR NECK WHERE IT IS JOINED TO THE PROFEMUR® PLASMA Z FEMORAL STEM ADDITIONAL THE PATIENT IS NOW SCHEDULED TO HAVE HIS RIGHT HIP REVISED ON (B)(6) 2022, BY DR. IN (B)(6) 2021 PLAINTIFF DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS HIP JOINTS. IN (B)(6) 2021 AN MRI DEMONSTRATED LARGE FLUID FILLED COLLECTIONS OVER BOTH OF PLAINTIFF'S HIPS. IN (B)(6) 2021 LABORATORY TESTS ALSO REVEALED THAT PLAINTIFFS COBALT AND CHROMIUM LEVELS IN HIS BLOOD WERE SIGNIFICANTLY ELEVATED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14377991 ↗
• InjuryJul 23, 2021Corroded; Appropriate Device Problem Term/Code Not Available; Corroded

  ALLEGEDLY, FEMORAL IMPLANTS REMOVED AND ACETABULAR LINER EXCHANGED DUE TO COMPLICATIONS FROM METAL ALLERGY (PER SURGEON).

  Patient problems: Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain

  MAUDE report 12219759 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION AND METALLOSIS IN THE NECK AND FEMORAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 9930735 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, FOR UNKNOWN REASONS PATIENT RECEIVED A REVISION.

  Patient problems: No Information

  MAUDE report 9845014 ↗
• InjuryFeb 26, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE COCR MODULAR NECK AND TITANIUM STEM, ELEVATED COBALT IONS LEVELS AND LOOSENING OF THE ACETABULAR COMPONENT.

  Patient problems: No Information

  MAUDE report 9758246 ↗