Freedom® Hip System 11-107016Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304203433), received between Feb 5, 2021 and Mar 4, 2025 — classified as 6 injuries.
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 Problem1
- Unstable1
Patient problems
- Joint Dislocation5
- Pain2
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 21514878 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT TWO REVISIONS DUE TO INFECTION.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 20852326 ↗InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 9 MONTHS AND 12 DAYS POST IMPLANTATION DUE TO A DISLOCATION. LOOKING AT THE LINER UPON REMOVAL IT WAS EVIDENT THERE WAS SOME DAMAGE THAT LOOKED TO BE FROM LEVERING. SURGEON WAS UNCERTAIN IF IT WAS A DEFICIENCY OR IF MAXIMUM LEVERAGE FORCE WAS ACHIEVED THAT ALLOWED THIS LINER TO BE DAMAGED/ FOR THE HIP TO DISLOCATE AND BE REDUCED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19766462 ↗InjuryFeb 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT 5 PREVIOUS LEFT HIP REVISIONS WITHIN 14 YEARS POST IMPLANTATION. SUBSEQUENTLY, THAT PATIENT UNDERWENT A SIXTH REVISION APPROXIMATELY 3 MONTHS LATER DUE TO PAIN AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation; Pain
MAUDE report 16352393 ↗InjuryOct 28, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT UNDERWENT A FIRST REVISION APPROXIMATELY FIVE MONTHS LATER DUE TO DISLOCATIONS AND STEM SUBSIDENCE. SUBSEQUENTLY, PATIENT UNDERWENT THE SECOND REVISION APPROXIMATELY 1 YEAR AND 3 MONTHS LATER DUE TO DISLOCATION, PAIN, AND INSTABILITY. THE LINER AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. THE STEM AND CUP REMAINED IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; Pain
MAUDE report 15690174 ↗InjuryFeb 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 11286076 ↗
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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