Profemur PHA01224Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PHA012241), received between Nov 5, 2015 and Aug 30, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (5 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.

• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12388633 ↗
• InjuryNov 6, 2020Break; Break

  ALLEGEDLY, ON (B)(6) 2020 THE FEMORAL NECK OF THE DEVICE FAILED FRACTURING INTO TWO PIECES, ON THAT SAME DATE THE DEVICE WAS SURGICALLY REMOVED. DURING THE REVISION PROCEDURE THE DOCTOR OBSERVED METALLOSIS DEEP IN THE HIP. (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10800636 ↗
• InjuryAug 12, 2020Break; Break

  ALLEGEDLY , PATIENT WAS REVISED DUE TO FRACTURED NECK OF HIP. REVISED WITH MPO'S LIPPED 15 DEGREE POLY LINER. STEM, NECK AND METAL FEMORAL HEAD OF ANOTHER MANUFACTURER USED DURING REVISION. (B)(6).

  Patient problems: No Information

  MAUDE report 10397570 ↗
• InjuryFeb 26, 2020Break; Break

  ALLEGEDLY, THE PATIENT WENT TO EMERGENCY DUE TO A HIP DISLOCATION. THE X RAYS SHOWED THE FRACTURE NECK. AEMPS REFERENCE: (B)(4).

  Patient problems: No Information

  MAUDE report 9756732 ↗
• InjuryJan 13, 2020Break; Break

  ALLEGEDLY PATIENT REPORTS THAT WHILE WALKING HE SUDDENLY FELT A SHARP PAIN IN THE AREA OF THE LEFT HIP AND FELL DOWN. BASG REF.: (B)(4).

  Patient problems: Pain

  MAUDE report 9583399 ↗
• InjuryNov 5, 2015Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO FRACTURED NECK. RECEIVED ADDITIONAL INFORMATION ON 10/14/2015: PATIENT REVISED ON (B)(6) 2014.

  Patient problems: No Information

  MAUDE report 5205672 ↗