OR3O Dual Mobility 71353303Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556710463), received between Sep 11, 2020 and Jun 5, 2025 — classified as 1 injury, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SCREW DISASSOCIATED FROM (1) OR3O DUAL MOBILITY TRIAL LINER 40/52. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155755 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THR SURGERY, THE SILVER LOCKING WASHER SPRUNG OF ONE (1) OR3O DUAL MOBILITY TRIAL LINER 40/52 WAS APART, BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598041 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A OR3O DUAL MOBILITY TRIAL LINER 40/52 WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629442 ↗
• MalfunctionJul 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE OR3O DUAL MOBILITY TRIAL LINER 40/52 RETAINING RING CAME OUT. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064559 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT, THE SCREW MECHANISM OF AN OR3O DUAL MOBILITY TRIAL LINER 40/52 WAS BROKEN. THIS WAS NOTICED UPON SET-UP OR INSPECTION FOR A TKA SURGERY. THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365100 ↗
• MalfunctionApr 28, 2021Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING FIELD INSPECTION A OR3O DUAL MOBILITY TRIAL LINER 40/52 HOLDING SCREW ON TRIAL HEAD WAS LOOSE AND DETACHED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742487 ↗
• MalfunctionMar 10, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SCREW CAP IS MISSING THE RING, SO THE SCREW FALLS OUT LOOSE. IT IS UNKNOWN WHEN THE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449824 ↗
• MalfunctionJan 12, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE LINER CRACKED WHILE OUTSIDE OF THE PATIENT. SURGERY WAS NOT DELAYED AS A BACK UP DEVICE WAS READILY AVAILABLE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155324 ↗
• MalfunctionDec 24, 2020Crack; Crack

  IT WAS REPORTED THAT, DURING A STANDARD INSPECTION, DEVICE WAS FOUND TO BE CRACKED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072286 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED THAT AN OR3O DUAL MOBILITY TRIAL LINER 40/52 WAS FOUND BROKEN. THIS WAS FOUND DURING INSPECTION. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10766494 ↗
• MalfunctionOct 28, 2020Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT UPON INSPECTION OF THIS SET THIS PIECE WAS WEDGE BETWEEN TWO PARTS OF THE TRAY AND HAD A CHUCK CUT INTO IT FROM THE TRAY. SCREW NO LONGER FITS IN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10750805 ↗
• InjurySep 11, 2020Break; Break

  IT WAS REPORTED THAT DURING THR SURGERY THE OR3O DUAL MOBILITY TRIAL LINER 40/52 BROKE. THIS HAPPENED DURING USE INSIDE THE PATIENT. NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS CONCLUDED. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10523571 ↗