OR3O Dual Mobility 71358204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556712252), received between Jan 18, 2022 and Sep 17, 2024 — classified as 3 injuries.

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 RIGHT HIP ON (B)(6) 2021, DUE TO (1) A RIGHT HIP PERIPROSTHETIC JOINT INFECTION AND (2) A RIGHT REVISION HIP PROSTHETIC DISLOCATION. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A FEMORAL SYSTEM FROM A COMPETITOR. THE IDENTITY OF THE HIP SYSTEM EXPLANTED DURING HTIS REVISION SURGERY IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM A SUPERFICIAL INCISIONAL INFECTION OF THE SURGICAL SITE FOLLOWING THE PROCEDURE. THE ISSUE WAS RESOLVED BY PERFORMING 2 STAGE REVISION SURGERY DURING (B)(6) 2021. DURING THIS REVISION SURGERY, THE FEMORAL HEAD AND ACETABULAR LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20238536 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A PRIMARY THA PROCEDURE PERFORMED ON (B)(6) 2020 DUE TO OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, ONE (1) PATIENT SUSTAINED A HIP DISLOCATION AT 3-4 POSTOPERATIVE MONTHS THAT REQUIRED A REVISION SURGERY. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19845903 ↗
• 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 13281980 ↗