X3 1236-2-242Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540665881), received between Oct 26, 2018 and Mar 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K103233); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DUE TO CONTINUED DRAINAGE FROM THE SURGICAL SITE OF THE PATIENT IN THE ABOVE OPERATION, INTERNAL WOUND IRRIGATION AND PART REPLACEMENT WERE PERFORMED. ACCORDING TO THE SURGEON, THIS IS NOT AN INFECTIOUS CONDITION.

  Patient problems: Fluid Discharge

  MAUDE report 21503723 ↗
• InjuryJul 3, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON (B)(6) 2024, PRIMARY SURGERY WAS PERFORMED AND THE DEVICES WERE IMPLANTED IN THE LEFT HIP. DISLOCATION BETWEEN THE METAL HEAD AND THE POLYETHYLENE INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 19669891 ↗
• InjuryOct 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. THE ENTIRE CONSTRUCT WAS REVISED (STEM, SHELL, AND METAL LINER WERE REVISED TO ADJUST PATIENT'S VERSION, THERE ARE NO ALLEGATIONS AGAINST THE DEVICES).

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8009963 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103233. One submission often covers many models, so check the product and lot details in each record.

• Z-0192-2012 · Jun 3, 2011 · Terminated
  Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av d