OR3O Dual MobilityRecalls & reported problems across all models
Smith & Nephew, Inc. · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 116
- Deaths reported
- 0
- Injuries reported
- 61
- Recalls
- 0
We found 30 models of OR3O Dual Mobility by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2020 and Apr 3, 2026 — classified as 61 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Break” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OR3O Dual Mobility problems
Device problems
- Adverse Event Without Identified Device or Use Problem34
- Break29
- Device Dislodged or Dislocated19
- Detachment of Device or Device Component17
- Fracture7
- Connection Problem3
- Crack3
- Improper or Incorrect Procedure or Method2
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- Joint Dislocation34
- Medical device site infection8
- Failure of Implant6
- Fall4
- Insufficient Information4
- Unspecified Infection4
- Joint Laxity3
OR3O Dual Mobility models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OR3O Dual Mobility 71353303PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED12 reports
- OR3O Dual Mobility 71353304PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED11 reports
- OR3O Dual Mobility 71358206PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED9 reports
- OR3O Dual Mobility 71353301PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- OR3O Dual Mobility 71358219PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- OR3O Dual Mobility 71353302PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- OR3O Dual Mobility 71353305PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- OR3O Dual Mobility 71358214PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- OR3O Dual Mobility 71358216PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- OR3O Dual Mobility 71353306PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- OR3O Dual Mobility 71358202PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- OR3O Dual Mobility 71358203PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- OR3O Dual Mobility 71358218PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- OR3O Dual Mobility 71353318PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- OR3O Dual Mobility 71358204PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- OR3O Dual Mobility 71358207PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- OR3O Dual Mobility 71358213PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- OR3O Dual Mobility 71353307PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OR3O Dual Mobility 71353314PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OR3O Dual Mobility 71353319PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OR3O Dual Mobility 71358201PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OR3O Dual Mobility 71358205PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OR3O Dual Mobility 71358221PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OR3O Dual Mobility 71353316PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OR3O Dual Mobility 71353323PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OR3O Dual Mobility 71353325PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OR3O Dual Mobility 71358209PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OR3O Dual Mobility 71358211PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OR3O Dual Mobility 71358217PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OR3O Dual Mobility 71358222PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent OR3O Dual Mobility adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT, DURING A THA SURGERY, THE HIP COULD NOT BE REDUCED DUE TO IT BEING REALLY TIGHT AND ONE (1) OR3O DUAL MOBILITY TRIAL INSERT 28/54 BROKE WHILE TRYING TO REMOVE IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774265 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH IV ANTIBIOTICS AND BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE HIP WAS WASHOUT AND AN EXCHANGE OF THE OR3O DM XLPE INSERT 28/40 AND THE OXINIUM FEM HD 12/14 28MM +0 WAS PERFORMED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 24143913 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN ACETABULAR REVISION SURGERY, AT THE TIME OF PERFORMING TESTS WITH THE OR3O DUAL MOBILITY TRIAL LINER 38/50, IT WAS ATTACHED TO THE ACETABULAR CUP USING THE INTERNAL RETAINING SCREW. THE RELEVANT TESTS WERE COMPLETED AND UPON DISASSEMBLING IT FROM THE CUP, THE RETAINING SCREW CAME LOOSE, COMPLETELY DETACHING AND PREVENTING IT FROM BEING REATTACHED. THE SCREW DID NOT FELL INSIDE THE PATIENT. THIS OCCURRED AFTER ALL NECESSARY TESTS FOR THE IMPLANTATION OF THE FINAL DEVICE HAD ALREADY BEEN PERFORMED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917851 ↗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 ↗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 ↗InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND ONE (1) OR3O DM XLPE INSERT 28/48 DISASSOCIATED FROM ONE (1) OXINIUM FEM HD 12/14 28MM +0. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE DEVICES WERE REPLACED WITH NEW 48/62 OR30 LINER, 28/48 OR30 INSERT, AND 28MM +8 OXINIUM HEAD. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.
Patient problems: Fall
MAUDE report 23511679 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY WOUND DEBRIDEMENT, WASHOUT AND A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE OR3O DUAL MOBILITY LINER 44/58 AND THE OR3O DM XLPE INSERT 28/44 WERE REMOVED AND EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 23451379 ↗InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A LEFT DISLOCATION OF THE OR3O DUAL MOBILITY LINER 40/52 AFTER MOVING TO LATERAL SIDE ON BED. THIS ADVERSE EVENT WAS SOLVED BY A MEDICAL INTERVENTION ON (B)(6) 2025, IN WHICH CAPTAIN MORGAN TECHNIQUE WAS PERFORMED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Dislocation; Pain
MAUDE report 22465349 ↗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 ↗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 ↗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 ↗InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, THE PATIENT FRACTURED THE HIP FOR WHICH A CEPHALOMEDULLARY NAIL WAS PLACED, WHICH CAUSED SHORTENING AND LIMPING. FOR THIS REASON, THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON THE (B)(6) 2023. IN THE POSTOPERATIVE PERIOD, THE PATIENT PRESENTED INSTABILITY WITH RECURRENT DISLOCATION, SO A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023 IN WHICH THE OR3O DUAL MOBILITY XLPE INSERT 22/40 WAS REPLACED FOR A NEW DEVICE OF THE SAME CONFIGURATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 21118655 ↗InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A FIRST REVISION THR SURGERY WAS PERFORMED ON THE (B)(6)2023, THE PATIENT CONTINUED TO PRESENT INSTABILITY PROBLEMS. THEREFORE, A SECOND REVISION SURGERY WAS PERFORMED ON THE (B)(6) IN WHICH THE OR3O DUAL MOBILITY XLPE INSERT 22/40 WAS REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Joint Laxity
MAUDE report 21086495 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THA RE-REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2024, THE PATIENT COMPLAINT OF PAIN. ON THE (B)(6) 2024 THE PATIENT UNDERWENT A HIP ASPIRATION PROCEDURE WHICH DIAGNOSED THE PATIENT WITH INFECTION AND INFLAMMATORY REACTION TO THE PROSTHETIC HIP. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND PAIN MEDICATION WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT UNDERWENT A I&D REVISION IN WHICH THE LINER WAS ALSO EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Bacterial Infection; Medical device site infection; Pain
MAUDE report 21067096 ↗MalfunctionDec 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) OR3O DUAL MOBILITY TRIAL LINER 46/60 BROKE WHILE IN USE, AS THE CENTRAL SCREW DETACHED FROM THE PLASTIC TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT DELAY, WITH 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 20950216 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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