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
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
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 · TerminatedActive Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
- 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-1465-2013 · Apr 26, 2013 · TerminatedActive 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
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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