OR3O Dual Mobility 71353304Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556710470), received between Nov 2, 2020 and Dec 19, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, A SCREW CAME APART WHEN REMOVING ONE (1) OR3O DUAL MOBILITY TRIAL LINER 42/54. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849702 ↗
• MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, A SCREW OF ONE (1) OR3O DUAL MOBILITY TRIAL LINER 42/54 FELL OUT. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18974544 ↗
• MalfunctionSep 29, 2023Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT, DURING A THR, A WASHER ON AN OR3O DUAL MOBILITY TRIAL LINER 42/54 BROKE, WHICH PREVENTED THE LINER FROM BEING TIGHTENED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT HARMS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843953 ↗
• 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 16924849 ↗
• MalfunctionSep 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW OF AN OR3O DUAL MOBILITY TRIAL LINER 42/54 BROKE OFF. AS THIS HAPPENED DURING THE SET-UP FOR A THR SURGERY, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466511 ↗
• MalfunctionAug 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT AN OR3O DUAL MOBILITY TRIAL LINER 42/54 WAS SHIPPED BROKEN; AND THEREFORE, IT CAUSED TWO HOURS OF EXTRA SURGERY TIME. SURGEON COULD NOT DO THE TRIAL REDUCTION. IT IS UNKNOWN HOW THE ISSUE WAS SOLVED; HOWEVER, THE PATIENT LEFT THE OPERATING ROOM IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211384 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, A OR3O DUAL MOBILITY TRIAL LINER 42/54 BROKE. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303964 ↗
• InjuryMay 4, 2021Break; Break

  IT WAS REPORTED THAT DURING THR, THE RING THAT RETAINS THE SCREW INTO THE OR3O DUAL MOBILITY TRIAL LINER 42/54 BROKE WHEN INSIDE THE PATIENT. ALL THE PIECES WERE RECOVERED. NO SURGICAL DELAY REPORTED AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773174 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT DURING THR PROCEDURE THE SCREW OF THE OR3O DUAL MOBILITY TRIAL LINER 42/54 BROKE. THIS HAPPENED OUTSIDE THE PATIENT. NO PARTS FELL INTO PATIENT. THERE WAS NO DELAY AND PROCEDURE CONCLUDED WITH A S&N BACK UP DEVICE. 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 11283930 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED DURING THR PROCEDURE THAT THE TRIAL WAS BROKEN OUTSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW WAS THE PROCEDURE FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091084 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT THE SCREW BROKE IN THE OR3O DUAL MOBILITY TRIAL LINER 42/54. NOTHING FELL INTO PATIENT. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

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

  MAUDE report 10774782 ↗