OR3O Dual Mobility 71358205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556712269), received between Feb 9, 2021 and Feb 22, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PRIMARY SURGERY HAD BEEN PERFORMED ON 2020 TO ADDRESS A PREVIOUS FAILED HIP SURGERY, ONE (1) PATIENT EXPERIENCED A HIP INFECTION REQUIRED AN IRRIGATION AND DEBRIDEMENT (I&D) PROCEDURE. IT IS UNKNOWN WHICH DEVICES WERE EXCHANGED DURING THIS PROCEDURE. THE ONSET DATE FOR THE REPORTED SYMPTOMS AND FOR THE CONDUCTED I&D REMAINS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16417253 ↗
• InjuryFeb 9, 2021Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TKA, A REVISION SURGERY WAS PERFORMED DUE A DISLOCATION AND THE INSIDE OF THE OR3O DUAL MOBILITY LINER 44/56 WAS FOUND WITH WEAR. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11305549 ↗