Freedom Hip SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 1
- Injuries reported
- 32
- Recalls
- 0
We found 7 models of Freedom Hip System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2019 and Jun 9, 2026 — classified as 1 death, 32 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Freedom Hip System problems
Device problems
- Device Dislodged or Dislocated21
- Adverse Event Without Identified Device or Use Problem8
- Insufficient Device Problem Information4
- Unstable2
- Detachment of Device or Device Component1
- Patient Device Interaction Problem1
- Unintended Movement1
Patient problems
- Joint Dislocation22
- Insufficient Information5
- Pain5
- Failure of Implant2
- Loss of Range of Motion2
- Medical device site infection2
- Aspiration/Inhalation1
- Cardiac Arrest1
Freedom Hip System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Freedom® Hip System 11-107018Prosthesis, hip, constrained, cemented or uncemented, metal/polymer10 reports
- Freedom® Hip System 11-107021Prosthesis, hip, constrained, cemented or uncemented, metal/polymer7 reports
- Freedom® Hip System 11-107016Prosthesis, hip, constrained, cemented or uncemented, metal/polymer6 reports
- Freedom® Hip System 11-107017Prosthesis, hip, constrained, cemented or uncemented, metal/polymer4 reports
- Freedom® Hip System 11-107019Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 death4 reports
- Freedom® Hip System 11-107020Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- FREEDOM HIP SYSTEM 14-107020PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent Freedom Hip System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. DURING THE PROCEDURE, THE FREEDOM RINGLOC AND HEAD WERE REVISED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Joint Dislocation
MAUDE report 25449063 ↗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 ↗InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED PATIENT HAD PRIMARY HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED ONE (1) YEAR POST IMPLANTATION, AND THE HEAD AND LINER WERE EXPLANTED. THE PATIENT UNDERWENT AN ADDITIONAL REVISION SURGERY DUE TO DISLOCATION. THE LINER WAS EXPLANTED.
Patient problems: Joint Dislocation
MAUDE report 22495952 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THE PATIENT WAS EXPERIENCING WORSENING LEFT HIP, GROIN, BUTTOCK AND THIGH PAIN, LIMITED DAILY ACTIVITIES, AND MILD LIMP STARTING APPROXIMATELY 2 MONTHS POST-IMPLANTATION. THE PATIENT WAS ALSO NOTED TO HAVE SOME EDEMA TO THE FOOT. THE SURGEON PROVIDED A SHOE LIFT TO THE PATIENT FOR LEG LENGTH DISCREPANCY AND PATIENT CONTINUED PHYSICAL THERAPY; HOWEVER, THIS DID NOT PROVIDE ANY RELIEF. THE SURGEON REFERRED THE PATIENT TO AN ORTHOTIST FOR A CUSTOM SHOE. PATIENT ALSO PROVIDED FLECTOR PATCH FOR PAIN.
Patient problems: Pain; Unequal Limb Length
MAUDE report 22435142 ↗InjuryJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 22157359 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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