Profemur PHA01212Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684PHA012121), received between Feb 26, 2020 and Feb 8, 2024 — classified as 5 injuries.

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

• InjuryFeb 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, INTRA-ARTICULAR METALLOSIS SECONDARY TO TRUNNION WEAR, OSTEOLYSIS, PSEUDOTUMOR AND PROXIMAL PERI-PROSTHETIC FRACTURE.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 18672609 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED ON 02,SEP, 2021. ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Failure of Implant

  MAUDE report 12407239 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12389033 ↗
• InjuryFeb 22, 2021Mechanical Problem; Mechanical Problem

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY OF ABOUT 4MM ON THE RIGHT SIDE. RADIOGRAPHIC IMAGES SHOWED POSSIBLE LOOSENING OF CUP AND STEM. THE REVISION WAS SCHEDULED TO REPLACE THE HEAD AND NECK AND POSSIBLY THE LINER. WHEN TRYING TO REMOVE THE NECK FROM THE STEM, IT COULD NOT BE SEPARATED. SO THE STEM WAS ALSO REMOVED. ADDITIONAL INFORMATION RECEIVED ON 02/02/2021: REVISED PART AND LOT NUMBERS WERE PROVIDED AS WELL AS THE REASON FOR REVISION, MOREOVER THE REVISION SURGERY DATE.

  Patient problems: Unequal Limb Length

  MAUDE report 11357805 ↗
• InjuryFeb 26, 2020Break; Break

  ALLEGEDLY, THE PATIENT WENT TO EMERGENCY DUE TO A HIP DISLOCATION. THE X RAYS SHOWED THE FRACTURE NECK. AEMPS: PS/MRG/58073.

  Patient problems: No Information

  MAUDE report 9756699 ↗