OR3O Dual Mobility 71358207Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556712283), received between Jan 2, 2024 and Sep 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2022 DUE TO LOOSENING OF RIGHT FEMORAL COMPONENT. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A REDAPT FEMORAL SYSTEM. THE IDENTITY OF THE HIP SYSTEM IMPLANTED BEFORE THIS REVISION SURGERY IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM AN INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL RIGHT HIP PROSTHESIS ON (B)(6) 2022. THE ISSUE WAS RESOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022. DURING THIS REVISION SURGERY, THE ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20238851 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2021, DUE TO PROSTHESIS INFECTION. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A FEMORAL REPADT SYSTEM. THE IDENTITY OF THE PRIMARY HIP SYSTEM EXPLANTED IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM DISLOCATIONS OF THE LEFT HIP TWICE ON (B)(6) 2021 AND ONCE ON (B)(6) 2022. THE REPORTED ISSUE RESULTED IN READMISSION OF THE PATIENT TO THE HOSPITAL. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20208251 ↗
• InjuryJan 2, 2024Migration; Migration

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2023, THE LINER DISLOCATED AND AN UNKNOWN R3 HEAD BECAME DETACHED FROM IT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. PATIENTS' CURRENT HEALTH STATUS IN UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18430386 ↗