Active Articulation Hip System EP-200164Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304485129), received between Oct 28, 2022 and Oct 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A SECOND LEFT HIP REVISION APPROXIMATELY 6 WEEKS AFTER THE PREVIOUS DUE TO DISLOCATION AND FINDING THE BEARING HAD POPPED OFF THE HEAD COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 15690246 ↗

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.