Active Articulation Hip System EP-200148Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Active Articulation Hip System (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00880304485044), received between Nov 26, 2019 and Dec 9, 2025 — classified as 19 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 reports).
3 other recalls cover devices cleared under the same FDA submission (K101336, K110555, K161190); they may or may not involve this specific model.
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 Dislocated10
- Adverse Event Without Identified Device or Use Problem7
- Detachment of Device or Device Component5
- Fracture1
Patient problems
- Joint Dislocation9
- Pain4
- Unspecified Infection4
- Failure of Implant3
- Insufficient Information3
- Bone Fracture(s)1
- Fall1
- Necrosis1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Fracture; Fracture
InjuryJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISASSEMBLY OF THE POLY BEARING AND HEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22371253 ↗InjuryMay 29, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INFECTION AND DISLOCATION. THE PATIENT HAD A WASHOUT AND THE BEARING AND HEAD WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 22108580 ↗InjuryApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 21772874 ↗InjuryNov 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 20668305 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THIRTEEN MONTHS POST IMPLANTATION FOR UNKNOWN REASONS. THE BEARING, STEM AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20609877 ↗InjuryAug 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 19962905 ↗InjuryJul 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 MONTHS LATER DUE TO DISLOCATION AND STEM LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 19666257 ↗InjuryJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 19597430 ↗InjuryApr 26, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO A DISASSOCIATION AND FRACTURE AFTER EXPERIENCING A FALL. THE HEAD AND BEARING WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 19191103 ↗InjuryJun 9, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO DISLOCATION AND INFECTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 17098534 ↗InjuryNov 22, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PT FELL DAY 4 POST OP IN HER NURSING HOME AND DISLOCATED HER HIP. AN ATTEMPT AT A CLOSED REDUCTION WAS UNSUCCESSFUL, BUT DID CAUSE ACETABULAR SHELL TO MOVE. SURGERY WAS PERFORMED TO REVISE THE DISLOCATION AND LOOSENED SHELL. DURING REVISION PROCEDURE IT WAS FOUND THAT THE 28MM HEAD HAD DISSOCIATED FROM THE ARTICULATING 42MM E1 BEARING. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 15845467 ↗InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT IS EXPERIENCING EXCRUCIATING PAIN AT SEVERAL FOLLOW UPS AFTER TOTAL HIP ARTHROPLASTY. THE PATIENT WAS TREATED WITH ANALGESIA AND THE PAIN HAS SINCE RESOLVED. THE DEVICES REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 15510521 ↗InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED WOUND DEHISCENCE APPROXIMATELY 3 WEEKS AFTER A HIP REVISION. THE PATIENTS WOUND WAS REOPENED AND PROVIDED FLUXOCACILIN ORAL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Wound Dehiscence
MAUDE report 15420925 ↗InjuryAug 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO A DISLOCATION. NO ADDITIONAL INFORMATION.
Patient problems: Joint Dislocation
MAUDE report 15320740 ↗InjurySep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Necrosis; Pain
MAUDE report 12439302 ↗InjuryJul 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Fall; Joint Dislocation; Pain
MAUDE report 10331974 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION. SUBSEQUENTLY, PATIENT UNDERWENT THIRD REVISION APPROXIMATELY ONE AND HALF YEARS POST INITIAL IMPLANTATION FOR INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH CEMENT SPACERS. SALES REP INDICATES NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 9383125 ↗InjuryNov 26, 2019Adverse 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: Unspecified Infection
MAUDE report 9375544 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K101336, K110555, K161190. One submission often covers many models, so check the product and lot details in each record.
- Z-1024-2017 · Dec 19, 2016 · TerminatedRingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
- Z-1025-2017 · Dec 19, 2016 · TerminatedActive Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
- Z-1465-2013 · Apr 26, 2013 · TerminatedActive Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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.
How reports and recalls are matched · Editorial policy · Report an error on this page