OR3O Dual Mobility 71353302Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556710456), received between Nov 10, 2020 and Dec 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ACETABULAR REVISION SURGERY, AT THE TIME OF PERFORMING TESTS WITH THE OR3O DUAL MOBILITY TRIAL LINER 38/50, IT WAS ATTACHED TO THE ACETABULAR CUP USING THE INTERNAL RETAINING SCREW. THE RELEVANT TESTS WERE COMPLETED AND UPON DISASSEMBLING IT FROM THE CUP, THE RETAINING SCREW CAME LOOSE, COMPLETELY DETACHING AND PREVENTING IT FROM BEING REATTACHED. THE SCREW DID NOT FELL INSIDE THE PATIENT. THIS OCCURRED AFTER ALL NECESSARY TESTS FOR THE IMPLANTATION OF THE FINAL DEVICE HAD ALREADY BEEN PERFORMED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917851 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT, ONE (1) OR3O DUAL MOBILITY TRIAL LINER 38/50 BROKE DURING USE INSIDE THE PATIENT. NO ONE WAS HARMED. THE SCREW INSIDE THE LINER TRIAL SEEMED TO FALL APART WHEN THEY WERE TRYING TO SCREW IT INTO THE SHELL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, CHANGING SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991496 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT IN ONE (1) OR3O DUAL MOBILITY TRIAL LINER 38/50, A METAL ROUND PIECE BROKE AND FELL OUT, NOW SCREW IS NOT SECURE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544181 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT, AN OR3O DUAL MOBILITY TRIAL LINER 38/50 WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125914 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR, THE OR3O DUAL MOBILITY TRIAL LINER 38/50 BROKE OUTSIDE THE PATIENT. NO PIECES FELL INSIDE. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048689 ↗
• InjuryNov 10, 2020Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SCREW AND RING OF THE OR3O DUAL MOBILITY TRIAL LINER 38/50 BECAME DISASSOCIATED FROM PLASTIC DURING TRIALING. INSTRUMENTS INSIDE PATIENT. ALL PIECES RECOVERED. PROCEDURE FINISHED WITH SAME DEVICE. DELAY OF FIVE MINUTES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10816925 ↗