OR3O Dual Mobility 71358201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556712221), received between Jul 10, 2020 and Jan 25, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PRIMARY SURGERY HAD BEEN PERFORMED ON 2020 TO ADDRESS A PROXIMAL HIP JOINT FRACTURE, ONE (1) PATIENT REQUIRED AN IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD AND LINER EXCHANGE. THIS PROCEDURE WAS CONDUCTED WITHIN A POSTOPERATIVE PERIOD OF THREE (3) WEEKS, BUT THE EXACT DATE REMAINS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16243855 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THR REVISION SURGERY THE OR3O DUAL MOBILITY LINER 36/48 WAS TAKEN OUT DUE TO AN UNKNOWN ADVERSE TISSUE REACTION. A COMPETITOR IMPLANT WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY REPORTED.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 10261139 ↗