OR3O Dual Mobility 71353301Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556710449), received between May 12, 2021 and Dec 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THA SURGERY, WHEN REMOVING THE OR3O DUAL MOBILITY TRIAL LINER 36/48, MIDDLE SCREW CAME OUT. NO DELAY WAS REPORTED AND THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715429 ↗
• MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR, THE SET SCREW DETACHED FROM THE OR3O DUAL MOBILITY TRIAL LINER 36/48 AS THE SURGEON WAS TRYING TO THREAD THE TRIAL LINER INTO THE SHELL. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED BY CHANGING THE SURGICAL METHOD, THE SURGEON HAD TO USE THE IMPLANT LINER FOR TRIALING. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494916 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THR SURGERY, THE SCREW IN THE OR3O DUAL MOBILITY TRIAL LINER 36/48 DISASSEMBLED DURING REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607765 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE CENTER SCREW OF A OR3O DUAL MOBILITY TRIAL LINER 36/48 BROKE OUT AND IS NO LONGER WITH THE ITEM. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592161 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE INNER SCREW OF AN OR3O DUAL MOBILITY TRIAL LINER 36/48 BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119465 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE FOUND BROKEN: ONE (1) GENESIS II FEMORAL IMPLANT IMPACTOR (CASE-(B)(4)), ONE (1) OR3O DUAL MOBILITY TRIAL LINER 36/48 (CASE-(B)(4)), SIXTEEN (16) TRIGEN LIDS FOR OUTER CASES (CASE-(B)(4), CASE-(B)(4) TO CASE-(B)(4)), SEVEN (7) TRIGEN SMALL OUTER CASES - 2.4 (CASE-(B)(4), CASE-(B)(4) TO CASE-(B)(4)), THREE (3) TRIGEN LARGE OUTER CASES - 4.8, (CASE-(B)(4), CASE-(B)(4), CASE-(B)(4)), ONE (1) ZUK ARTICULAR SURFACE PROVISIONAL SIZE 4 8MM (CASE-(B)(4)), AND ONE (1) JOURNEY II BCS LOCKING FEMORAL IMPLANT IMPACTOR (CASE-(B)(4)). THIS WAS NOTED AS A DAMAGE DURING SHIPPING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114795 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE SCREW IN TRIAL BROKE OFF THE OR3O DUAL MOBILITY TRIAL LINER 36/48. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810802 ↗