OR3O Dual Mobility 71358218Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556712375), received between Jan 18, 2022 and Sep 12, 2024 — 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.

• 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 HER LEFT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2020 DUE TO RECURRENT INSTABILITY AND FAILED CONSTRAINED LINER FOLLOWING REVISION TOTAL HIP ARTHROPLASTY. DURING THE REVISION SURGERY, THE WHOLE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR SHELL AND A REDAPT FEMORAL SYSTEM. AS REPORTED, THE PATIENT SUFFERED FROM AN INFECTED LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 TO ADDRESS THE ISSUES. DURING THIS SECOND REVISION SURGERY, THE FEMORAL HEAD & ACETABULAR LINER 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 20208851 ↗
• InjuryJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT THA ON (B)(6) 2021, PATIENT SUSTAINED A DISLOCATION THAT REQUIRED REVISION SURGERY ON (B)(6) 2022. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19554446 ↗
• InjuryJan 17, 2023Adverse 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 (B)(6) 2022, THE PATIENT PRESENTED WITH A DISLOCATED HIP, AFTER A FALL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE OR3O DM XLPE INSERT 28/42 DEVICE AND THE FEMORAL HEAD. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16190736 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2021. THE PATIENT EXPERIENCED RECURRENT ANTERIOR DISLOCATION OF THE RIGHT HIPS; THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REVISE THE R3 MULTI HOLE ACETABULAR SHELL 54MM, OR3O DUAL MOBILITY LINER 42/54 AND THE OR3O DM XLPE INSERT 28/42. SURGICAL OUTCOME WAS SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13281681 ↗