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
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
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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