PROFEMUR® PHAC1244Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PHAC12441), received between Nov 21, 2019 and Apr 3, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, ON (B)(6) 2024, THE PATIENT REPORTED COMPLICATIONS FROM THE REVISION DEVICES. SECOND REVISION SURGERY EXPECTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21769049 ↗
• InjurySep 26, 2024Corroded; Naturally Worn; Corroded; Naturally Worn

  ALLEGEDLY, THE DEVICES FAILED DUE TO CORROSION OF THE MODULAR NECK AT THE HEAD-NECK JUNCTION AND WHERE THE NECK SEATED IN THE POCKET OF THE STEM, AND EARLY EXCESSIVE WEAR OF THE LINER. ALSO, PRODUCTION OF METAL DEBRIS RESULTING IN METALLOSIS, POLYETHYLENE WEAR DEBRIS, ADVERSE LOCAL TISSUE REACTION TO PARTICLES, WEAKNESS, AND PAIN.

  Patient problems: Pain

  MAUDE report 20311960 ↗
• InjuryApr 27, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT PRESENTED WITH PAIN AND LACK OF MOBILITY. THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. AT REVISION SURGERY, IT WAS DISCOVERED THAT THE DEVICE FAILED DUE TO CORROSION OF THE OBLONG TAPER OF THE PROFEMUR COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE PROFEMUR TITANIUM STEM.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14218899 ↗
• InjuryApr 21, 2021Corroded; Corroded

  ALLEGEDLY, THE PATIENT HAD A SECOND REVISION SINCE THE COCR MODULAR NECK FAILED. THE PATIENT PRESENTED PAIN, ELEVATED COBALT ION LEVELS, ADVERSE TISSUE REACTION AND CORROSION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11703680 ↗
• InjuryNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR PULLED THE NECK, HEAD, SLEEVE, LINER, AND 3 SCREWS AND CEMENTED IN A BIOMET CONSTRAINED LINER. THE PATIENT HAD A PREVIOUS REVISION FOR MOM, INCIDENT GROUP 19060012, A SECOND REVISION FOR INFECTION, INCIDENT GROUP 19060187, AND A THIRD REVISION FOR DISLOCATION, INCIDENT GROUP 19060015. ITEMS NOT REVISED: DYNASTY BIOFOAM SHELL DSBFGG60 LOT 079859623, PROFEMUR PLASMA Z STEM PHA00270 LOT 067445032.

  Patient problems: No Information

  MAUDE report 9358820 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED FROM A TOTAL HIP DUE TO A PSUEDO-TUMOR.

  Patient problems: Reaction

  MAUDE report 9354515 ↗