OR3O Dual Mobility 71358221Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556712399), received between Sep 2, 2022 and Jun 17, 2024 — classified as 2 injuries.

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

• InjuryJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED A DISLOCATION THAT REQUIRED RE-REVISION SURGERY ON (B)(6) 2022. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19554362 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 IN ORDER TO REPLACE THE OR3O DUAL MOBILITY LINER 46/60 WITH AN R3 CONSTRAINED LINER. DURING SURGERY, IT WAS NOTICED THAT THE OXINIUM FEM HD 12/14 28MM +0 AND THE OR3O DM XLPE INSERT 28/46 HAD DISSOCIATED. IT WAS UNKNOWN TO SURGEON IF THIS RESULTED FROM THE FORCES APPLIED TO THE HIP FOR DISLOCATION DURING THE PROCEDURE. THE OR3O DUAL MOBILITY LINER 46/60 WAS REMOVED WITHOUT SURGICAL DELAY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348859 ↗