OR3O Dual Mobility 71353306Recalls & reported problems
Smith & Nephew, Inc. · OR3O DUAL MOBILITY TRIAL LINER 44/58 · Class 2
All models of OR3O Dual Mobility (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556710494), received between Apr 21, 2021 and May 14, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING THR SURGERY, THE LOCKING WASHER OF ONE (1) OR3O DUAL MOBILITY TRIAL LINER 44/58, FELL OUT. 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 22023493 ↗MalfunctionDec 14, 2021Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, AN OR3O DUAL MOBILITY TRIAL LINER 44/58 BROKE. IT IS UNKNOWN IF ANY PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13002217 ↗MalfunctionDec 13, 2021Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, AN OR3O DUAL MOBILITY TRIAL LINER 44/58 BROKE. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12990791 ↗MalfunctionApr 21, 2021Material Separation; Material Separation
IT WAS REPORTED THAT, DURING AN INSPECTION, IT WAS DISCOVERED THAT THE SNAP RING OF A OR30 DUAL MOBILITY TRIAL LINER 44/58 HAD POPPED OUT. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11704451 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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