Active Articulation Hip System EP-200152Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00880304485068), received between Nov 27, 2018 and Dec 17, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 23831178 ↗
• InjuryDec 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 3 YEARS POST IMPLANTATION DUE TO A DISLOCATION AT THE SITE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20967895 ↗
• InjuryDec 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 20901437 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT ONE OF THE IMPLANTED HIP ITEMS WAS RECALLED FOR A CLEANLINESS ISSUE AND IT WAS SUSPECTED THAT METAL IS LEAKING INTO THE BLOODSTREAM. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20138482 ↗
• InjurySep 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20127445 ↗
• InjuryJul 5, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 19680060 ↗
• InjuryOct 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE. SUBSEQUENTLY, THE PATIENT DISLOCATED, UNABLE TO REDUCE AND UNDERWENT A REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 17961227 ↗
• InjuryAug 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE DISLOCATIONS POST ACETABULAR REVISIONS TO THE G7 DM. THE PATIENT HAD DISLOCATED AND RETURNED TO THE ER WHERE AN INTRAPROSTHETIC DISLOCATION POST CLOSED REDUCTION WAS FOUND. SUBSEQUENTLY, THE PATIENT WAS REVISED FOUR YEARS POST IMPLANTATION TO A FREEDOM CUP.

  Patient problems: Joint Dislocation

  MAUDE report 17664770 ↗
• InjuryJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT EXPERIENCED A HIP DISLOCATION AFTER A FALL AND UNDERWENT A REVISION SURGERY APPROXIMATELY 3 MONTHS POST IMPLANTATION. THE DUAL MOBILITY HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16130734 ↗
• InjuryAug 4, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REPLACED. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Hematoma; Joint Dislocation; Metal Related Pathology; Pain; Unequal Limb Length

  MAUDE report 15165314 ↗
• InjuryFeb 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION SURGERY AFTER EXPERIENCING RECURRENT DISLOCATION OF HER THA. THE PATIENT CURRENTLY HAD AN ACTIVE ARTICULATION CONSTRUCT THAT WAS THE RESULT OF A CONVERSION OF A METAL ON METAL MAGNUM CONSTRUCT TO ACTIVE ARTICULATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13508963 ↗
• InjuryJul 15, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED PRIMARY RIGHT THA WAS PLACED. SUBSEQUENTLY PATIENT EXPERIENCED PAIN, AND ELEVATED METAL IONS, AND UNDERWENT RIGHT THA REVISION OF HEAD TO DUAL MOBILITY CERAMIC INNER HEAD AND POLY E1 OUTER BEARING APPROXIMATELY TEN (10) YEARS POST IMPLANTATION. ADDITIONALLY ELEVEN (11) DAYS AFTER THE FIRST REVISION PATIENT UNDERWENT ORIF/REVISION DUE TO RIGHT THA DISLOCATION AND WAS FOUND DISASSOCIATION OF DUAL MOBILITY COMPONENTS, WITH IMPLANT WEAR, DEBRIS AND SMALL AMOUNT OF METALLOSIS WAS NOTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Metal Related Pathology

  MAUDE report 12173904 ↗
• InjuryDec 10, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT A HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION AND A SECOND REVISION APPROXIMATELY 1 MONTH AFTER THAT DUE TO DISLOCATION AND DISSOCIATION OF THE HEAD AND BEARING. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 10983999 ↗
• InjuryDec 10, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT A HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO DISLOCATION AND DISSOCIATION OF THE HEAD AND BEARING. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 10983984 ↗
• InjuryAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED 1 MONTH LATER DUE TO HIP DISLOCATION. SURGEON DISCUSSED THAT THE SHELL REQUIRES MORE VERSION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 10368918 ↗
• InjuryFeb 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 9677576 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION FOR UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 8107306 ↗

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-1025-2017 · Dec 19, 2016 · Terminated
  Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
• Z-1024-2017 · Dec 19, 2016 · Terminated
  RingLoc 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-1465-2013 · Apr 26, 2013 · Terminated
  Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.