Active Articulation Hip System EP-200146Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00880304485037), received between Feb 21, 2020 and Nov 20, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY A YEAR AND A HALF LATER DUE TO ONGOING PAIN, SPECIFICALLY IN HIP FLEXION AND EXTERNAL ROTATION. THE JOINT WAS OPENED AND THE CUP ORIENTATION EVALUATED. THE SURGEON FELT THAT THE CUP WAS CAPTURED BY BONE (SO WAS NOT PROUD). AN ILIOPSOAS RELEASE WAS PERFORMED AND A NEW BEARING AND HEAD IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 23607594 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22936759 ↗
• InjuryJul 10, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION OF THE LINER AND BEARING. THE SURGEON ATTEMPTED A MANUAL REDUCTION OF THE DISLOCATION AND THEN THE BEARING AND HEAD SEPARATED. ALL COMPONENTS REVISED EXCEPT THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 22472966 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED NEARLY ONE (1) YEAR POST IMPLANTATION DUE TO DISLOCATION. THE LINER WAS EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22168790 ↗
• InjuryFeb 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21332498 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20452659 ↗
• InjurySep 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND FIVE MONTHS POST RIGHT TOTAL HIP ARTHROSCOPY, THE PATIENT DEVELOPED PAIN AND HAD A DISASSOCIATION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE RELATED TO THE INITIAL DISASSOCIATION. SUBSEQUENTLY, APPROXIMATELY ONE MONTH AGO, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A DISLOCATION. THE HEAD WAS RELOCATED; HOWEVER, THE X-RAY SHOWED A DISASSOCIATION. THE PATIENT WAS REVISED AND DURING THE PROCEDURE, A LARGE AMOUNT OF METALLOSIS WITH SOME DAMAGE TO THE NECK OF THE STEM WAS NOTED. THE HEAD WAS OBSERVED TO HAVE SIGNIFICANT METAL DEBRIS AND HAD DISASSOCIATED FROM THE BEARING. THE BEARING SHOWED DAMAGE AND WAS FLOATING IN SOFT TISSUE. WEAR WAS ALSO NOTED TO THE LINER, WHICH MADE IT DIFFICULT TO REMOVE. THE STEM NECK WAS FOUND TO BE IMPINGING ON THE LINER RIM. FURTHER DAMAGE WAS CAUSED DURING REMOVAL, AS THE SUCTION CUP AND VIBRATION TECHNIQUES FAILED. AN OSTEOTOME WAS USED TO REMOVE THE DAMAGED LINER. THE SURGEON DECIDED THAT FURTHER CONSTRAINT WAS REQUIRED DUE TO THE SOFT TISSUE DAMAGE CAUSED BY THE METALLOSIS. EXTENSIVE DEBRIDEMENT WAS MADE, AND THE HEAD AND LINER WERE INSERTED, AND THE STEM WAS REVISED. NO ADDITIONAL INFORMA

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 20190735 ↗
• InjuryJul 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION FIVE (5) YEARS POST IMPLANTATION. THE CAUSE FOR THE DISLOCATION IS UNKNOWN. THE STEM, HEAD, AND BEARINGS WERE REPLACED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 19642752 ↗
• InjuryJun 10, 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 19505635 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 6 WEEKS LATER DUE TO AN INFECTED HEMATOMA. UPON REVISION, IT WAS NOTED THAT THE HEMATOMA COMMUNICATED INTO THE JOINT SPACE TO THE PROSTHESIS. A DEEP IRRIGATION AND DEBRIDEMENT WAS PERFORMED, AND THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 18383277 ↗
• InjuryNov 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18168807 ↗
• InjurySep 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY HIP PROCEDURE DUE TO TUMOR. SUBSEQUENTLY, THE PATIENT EXPERIENCED JOINT DISLOCATION AND UNDERWENT A REVISION APPROXIMATELY 1 MONTH LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 15382702 ↗
• InjuryApr 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 7 MONTH 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

  MAUDE report 13993496 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12512952 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12512937 ↗
• MalfunctionMay 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 15 MONTHS POST IMPLANTATION DUE TO FRACTURING DISTALLY OF THE STEM AFTER THE PATIENT EXPERIENCED A FALL. DURING THE REVISION, EXCESSIVE SCUFFING WAS FOUND ON THE DUEL MOBILITY BEARING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11776744 ↗
• InjuryJan 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 DAYS POST IMPLANTATION DUE TO THE IMPLANT APPEARING TOO LONG AND FEELING OF BEING UNCOMFORTABLE ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Discomfort; No Code Available

  MAUDE report 11131232 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Blood Loss; Death; Pain

  MAUDE report 9738536 ↗

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