OR3O Dual Mobility 71358203Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556712245), received between Mar 4, 2021 and Jul 9, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A LEFT DISLOCATION OF THE OR3O DUAL MOBILITY LINER 40/52 AFTER MOVING TO LATERAL SIDE ON BED. THIS ADVERSE EVENT WAS SOLVED BY A MEDICAL INTERVENTION ON (B)(6) 2025, IN WHICH CAPTAIN MORGAN TECHNIQUE WAS PERFORMED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22465349 ↗
• InjuryDec 16, 2024Adverse 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 ON UNKNOWN DATE, DUE TO RECURRENT COMPLICATIONS WITH THE PATIENT'S PROSTHESIS, THE SURGEON DETERMINED THAT THE OR3O DUAL MOBILITY LINER 40/52 NEEDS TO BE REPLACED WITH A R3 CONSTRAINED ACETABULAR LINER 52MM. THE PATIENT NEEDS TO BE REVISED AND CONVERTED FROM AN ACETABULAR CUP THAT HAS A DUAL MOBILITY IMPLANT TO A CONSTRAINED CUP. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20939289 ↗
• InjurySep 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED ACUTE PAIN IN THE LEFT HIP AND THE LEFT PROSTHESIS WAS DISLOCATED. THE PATIENT UNDERWENT A REVISION SURGERY. THIS ISSUE IS STILL BEING RESOLVED.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 12538263 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY IN THE RIGHT HIP AND DISLOCATION. THERE IS A DISSOCIATION OF THE DUAL MOBILITY BEARING.

  Patient problems: Joint Dislocation

  MAUDE report 11417806 ↗