PROFEMUR® PHAC1212Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684PHAC12121), received between Apr 21, 2021 and Sep 2, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Corroded” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  ALLEGEDLY, A PATIENT WITH BMI OVER 40 AND HAS ADVISED LEGAL THAT BROUGHT SURGEON TO FOLLOW UP WITH HOSPITAL. ADDITIONAL INFORMATION RECEIVED ON 09-19-2025: THE PATIENT WAS EXPERIENCING PAIN, POSSIBLY FROM METAL REACTION BETWEEN COCR MODULAR NECK AND FEMORAL STEM. IT WAS REPORTED THAT BONE AND TISSUE WAS REMOVED DURING THE REVISION WITH VISIBLE EVIDENCE OF A REACTION. THE COCR NECK WAS REPLACED WITH A TITANIUM MODULAR NECK. ADDITIONAL INFORMATION RECEIVED ON 01-27-2026: REVISION SURGERY WAS NECESSARY DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE. MEDICAL RECORDS INDICATE, AMONG OTHER THINGS: DARK GREY TO BLACK RESIDUE ON THE FEMORAL NECK COMPONENT FROM THAT JUNCTION INTO THE FEMORAL STEM; METALLOSIS WITH SOFT TISSUE EROSION; AND TENDON REPAIRS RELATED TO TISSUE NECROSIS AND PSEUDOTUMOR FORMATION.

  Patient problems: Insufficient Information; Metal Related Pathology; Pain

  MAUDE report 22935258 ↗
• 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 12219858 ↗
• InjuryJul 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT REVISED DUE TO COPIOUS AMOUNT OF BLACK DISCOLORED TISSUE, BLACK DISCOLORATION OF THE JOINT CAPSULE CONSISTENT WITH METALLOSIS AND DISLOCATION. (LEFT HIP).

  Patient problems: Metal Related Pathology

  MAUDE report 12178672 ↗
• InjuryApr 21, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO A FAILED METAL-ON-METAL JUNCTION CORROSION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM.

  Patient problems: Pain

  MAUDE report 11703693 ↗