Freedom® Hip System 11-107021Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304203495), received between Feb 9, 2022 and Oct 31, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 8 MONTHS LATER DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18040285 ↗
• InjurySep 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ME 9-14. IT WAS REPORTED THAT DURING A REVISION OF UNKNOWN DEVICES, THE DOCTOR NOTED THAT THE ACETABULUM WAS NOT PREPARED CORRECTLY; THEREFORE, INSERTED THE CUP WITH FIXATION OF FOUR SCREWS. DURING THE ATTEMPTS OF REDUCTION, ENCOUNTERED DIFFICULTY AND UPON DELIVERY OF FORCE, LED TO ROTATION OF THE PRESS-FIT FEMORAL STEM. A CURVED STEM WAS THEN PLACED AND AS ADDITIONAL REDUCTION ATTEMPTS WERE MADE, THE STEM ALSO ROTATED, LEADING TO THE STEM BEING CEMENTED. IN THE PROCESS OF TESTING THE HIP, ONE EVENT OF DISLOCATION OCCURRED; THEREFORE, ADDITIONAL REDUCTION MANEUVERS WERE REPEATED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSPORTED OUT OF THE OR. AFTER APPROXIMATELY 1 HOUR, THE PATIENT WAS RETURNED TO THE OR DUE TO DISLOCATION. THE LINER WAS REVISED TO A FREEDOM LINER AND WAS SUCCESSFULLY REDUCED WITHOUT DISLOCATION. SUBSEQUENTLY, DUE TO THE USE OF TENSILE FORCE, THE CUP DETACHED FROM THE ACETABULAR WALL AND THE PATIENT WAS HOSPITALIZED HIP PENDENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17744741 ↗
• InjuryAug 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 17632206 ↗
• InjuryAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 17623971 ↗
• InjuryApr 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY ONE YEAR LATER DUE TO DISLOCATION. IT WAS REPORTED THAT ONLY THE HEAD WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16674507 ↗
• InjuryFeb 7, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Laxity

  MAUDE report 16313727 ↗
• InjuryFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON INTENDED TO CHANGE THE ANTEVERSION OF THE ARCOS PROXIMAL BODY DUE TO THE FREEDOM CONSTRAINED HEAD DISASSOCIATING FROM THE LINER. SUBSEQUENTLY, THE SURGEON WAS UNABLE TO DISLODGE THE ARCOS PROXIMAL BODY FROM THE DISTAL STEM. THEREFORE, HE REVISED THE FREEDOM LINER AND HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13500475 ↗