OR3O Dual Mobility 71358206Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556712276), received between Jul 30, 2020 and Nov 3, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP CONVERSION THA SURGERY ON (B)(6) 2021 DUE TO POST-TRAUMATIC OSTEOARTHRITIS OF THE RIGHT HIP WITH RETAINED HARDWARE. DURING THIS PROCEDURE, THE PRIMARY HARDWARE (UNKNOWN IDENTITY) WAS EXPLANTED AND A REDAPT ACETABULAR SYSTEM WAS IMPLANTED ALONG WITH A REDAPT FEMORAL SYSTEM. THE PATIENT SUFFERED FROM AN INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL RIGHT HIP PROSTHESIS AND REQUIRED A REVISION SURGERY ON (B)(6) 2022. DURING THIS REVISION, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20238802 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HIS LEFT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2021 DUE TO A FAILED LEFT TOTAL HIP REPLACEMENT. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A FEMORAL SYSTEM FROM A COMPETITOR. AS REPORTED, THE PATIENT SUFFERED FROM RECURRENT DISLOCATIONS OF THE LEFT HIP DURING SEPT-2021 AND REQUIRED READMISSION TO THE HOSPITAL. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20233179 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HER LEFT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2021 DUE TO AN UNSTABLE LEFT HIP ARTHROPLASTY. DURING THE REVISION SURGERY, THE ACETABULAR SECTION OF THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A FEMORAL HEAD FROM A COMPETITOR. THE FEMORAL COMPONENT WAS NOT EXPLANTED DURING THIS PROCEDURE. AS REPORTED, THE PATIENT SUFFERED FROM A DISLOCATION OF THE LEFT HIP AND REQUIRED A REVISION SURGERY ON (B)(6) 2021. DURING THIS SECOND SURGERY, THE FEMORAL HEAD AND THE CONSTRAINED LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20232893 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP - FRACTURE FIXATION SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2021 DUE TO NONUNION OF RIGHT INTERTROCHANTERIC FEMUR FRACTURE, WITH SCREW CUT-OUT OF CEPHALOMEDULLARY SCREW. DURING THE REVISION SURGERY, THE TRAUMA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A FEMORAL REPADT SYSTEM. AS REPORTED, THE PATIENT SUFFERED FROM A DEEP WOUND INFECTION ON OCT-2021, AND UNDERWENT AN ADDITIONAL SURGERY ON THAT SAME MONTH. DURING THIS PROCEDURE, THE FEMORAL HEAD ACETABULAR LINER & INSERT WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20230656 ↗
• InjuryMar 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER PRIMARY THR WAS CONDUCTED ON AN UNKNOWN DATE IN WHICH COMPETITOR IMPLANTS WERE USED (DEPUY), THE PATIENT PRESENTED WITH IPD. THIS COMPLICATION WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024 IN WHICH THE DEPUY CUP WAS EXPLANTED AND A 58MM REDAPT MODULAR CUP WAS PLACED ALONG WITH AN OR3O DUAL MOBILITY LINER 44/58 AND A DEPUY 28MM +5 CERAMIC HEAD. ON (B)(6) 2024 A SECOND REVISION SURGERY WAS REQUIRED DUE TO HIP DISLOCATION. DURING THIS PROCEDURE, THE OR3O DUAL MOBILITY LINER 44/58 WAS EXCHANGED TO A 40MM LINER, AND THE FEMORAL HEAD WAS REPLACED WITH A DEPUY 40MM HEAD. THE 58MM REDAPT MODULAR CUP WAS LEFT IN SITU. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18956662 ↗
• InjuryMar 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, PLAINTIFF UNDERWENT A SECOND REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2022 DUE TO DISLOCATION AND INSTABILITY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16620171 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JUNE 22ND A SURGEON PERFORMED AN REVISION PROCEDURE UTILIZING AN OR3O LINER IN A REDAPT MODULAR ACETABULAR SHELL. ON JUNE 23RD THE PATIENT DISLOCATED AND ADDITIONAL REVISION PROCEDURE TO BE PERFORMED. ON JUNE 25TH THE SURGEON PERFORMED ADDITIONAL REVISION SURGERY ALTERING THE CUP INCLINATION TO 45 DEGREES AND UTILIZED A NEW OR3O DUAL MOBILITY LINER.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10344732 ↗