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Freedom® Hip System 11-107018Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of Freedom Hip System (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
10
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304203464), received between Jan 20, 2020 and Mar 20, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated5
  • Adverse Event Without Identified Device or Use Problem4
  • Insufficient Device Problem Information1
  • Unintended Movement1

Patient problems

  • Joint Dislocation5
  • Medical device site infection2
  • Pain2
  • Aspiration/Inhalation1
  • Cardiac Arrest1
  • Hemorrhage/Blood Loss/Bleeding1
  • Insufficient Information1
  • Joint effusion1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 20, 2026Device Dislodged or Dislocated

    IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Joint Dislocation

    MAUDE report 24650408 ↗
  • InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Medical device site infection; Necrosis; Scar Tissue

    MAUDE report 23495987 ↗
  • InjuryNov 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

    Patient problems: Joint Dislocation

    MAUDE report 23475497 ↗
  • InjuryOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT UNDERWENT A SECOND STAGE RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY AN INCISION AND DRAINAGE WITH STEM, HEAD AND LINER EXCHANGE. SUBSEQUENTLY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH WORSENING PAIN. A CT SCAN SHOWED A LARGE FLUID COLLECTION. THE ADVERSE EVENT WAS CLASSIFIED AS A DEEP JOINT INFECTION. AN ASPIRATION WAS PERFORMED; HOWEVER, NO FURTHER INFORMATION HAS BEEN REPORTED AT THIS TIME.

    Patient problems: Joint effusion; Medical device site infection; Pain

    MAUDE report 23242915 ↗
  • InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE BEARING AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Joint Dislocation

    MAUDE report 20450106 ↗
  • InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Patient problems: Aspiration/Inhalation; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pneumonia; Stroke/CVA

    MAUDE report 19528608 ↗
  • InjuryFeb 17, 2023Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

    IT WAS REPORTED THAT A PATIENT UNDERWENT 3 PREVIOUS LEFT HIP REVISIONS WITHIN 14 YEARS POST IMPLANTATION. SUBSEQUENTLY, THAT PATIENT UNDERWENT A FOURTH REVISION APPROXIMATELY 1 MONTH LATER DUE TO DISLOCATION. THE HEAD WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Insufficient Information; Joint Dislocation

    MAUDE report 16395261 ↗
  • InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING LEFT HIP PAIN APPROXIMATELY SEVEN (7) YEARS POST IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Pain

    MAUDE report 15138524 ↗
  • InjuryMar 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Patient problems: Joint Dislocation

    MAUDE report 9829943 ↗
  • MalfunctionJan 20, 2020Unintended Movement; Unintended Movement

    A PATIENT HAD REVISION RIGHT THA WITH CEMENT SPACERS PLACED DUE TO INFECTION. IMMEDIATELY POSTOPERATIVE IT WAS NOTED THAT ABDUCTION WAS LIMITED TO ABOUT 20 DEGREES WITH IMPINGEMENT OF THE NECK ONTO THE ACETABULAR COMPONENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Patient problems: Loss of Range of Motion

    MAUDE report 9608349 ↗

Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices

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Sources and updates

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