OR3O Dual Mobility 71353305Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556710487), received between Dec 29, 2021 and Feb 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR, A SCREW BROKE OUT OF A (1) OR3O DUAL MOBILITY TRIAL LINER 44/56. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE, BUT IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21478471 ↗
• MalfunctionJul 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR, THE INNER SCREW IN TWO (2) OR3O DUAL MOBILITY TRIAL LINER 44/56 HAVE DISSOCIATED AWAY FROM THE TRIAL. SURGERY WAS PERFORMED, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671843 ↗
• MalfunctionMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE JUMP RING BETWEEN PLASTIC AND METAL THREAD OF A OR3O DUAL MOBILITY TRIAL LINER 44/56 CAME OUT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919756 ↗
• MalfunctionJul 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SCREW OF AN OR3O DUAL MOBILITY TRIAL LINER 44/56 BROKE OUTSIDE OF THE PATIENT, AND NO PIECES FELL INSIDE THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077504 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT THE OR3O DUAL MOBILITY TRIAL LINER 44/56 WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366671 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE INNER SCREW OF AN OR3O DUAL MOBILITY TRIAL LINER 44/56 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 13114106 ↗