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Active Articulation Hip System EP-200144Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of Active Articulation Hip System (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304485020), received between Mar 9, 2020 and Aug 27, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated6
  • Fracture3
  • Detachment of Device or Device Component2
  • Adverse Event Without Identified Device or Use Problem1
  • Naturally Worn1

Patient problems

  • Joint Dislocation6
  • Pain2
  • Failure of Implant1
  • Fall1
  • No Clinical Signs, Symptoms or Conditions1
  • Unequal Limb Length1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 27, 2026Fracture; Device Dislodged or Dislocated

    It was reported the patient underwent a revision approximately 17 months post-implantation due to dislocation. Attempts have been made and no further information has been provided.

    Patient problems: Joint Dislocation

    MAUDE report 50473844 ↗
  • InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Patient problems: Unequal Limb Length

    MAUDE report 22895035 ↗
  • InjuryAug 14, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE BEARING AND HEAD WERE REPLACED, AND THE OPERATION WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE BEARING WAS DAMAGED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Patient problems: Joint Dislocation

    MAUDE report 22805242 ↗
  • InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Joint Dislocation

    MAUDE report 19764560 ↗
  • InjuryJun 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Joint Dislocation

    MAUDE report 19608120 ↗
  • InjuryApr 1, 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 PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 1 YEAR POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13977642 ↗
  • InjuryOct 7, 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; Pain

    MAUDE report 12589506 ↗
  • InjuryMay 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Fall; Joint Dislocation

    MAUDE report 11761270 ↗
  • InjuryMar 9, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Patient problems: Pain

    MAUDE report 9806751 ↗

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.

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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