OR3O Dual Mobility 71358219Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556712382), received between Sep 25, 2020 and Nov 4, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT FELL AND DISLOCATED THE HIP. ON THE X-RAY IT WAS NOTICED THAT THE OR3O DM XLPE INSERT 28/44 HAD DISASSOCIATED FROM THE OXINIUM FEM HD 12/14 28MM +0. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO CORRECT THE ISSUE USING COMPETITOR DEVICES. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Failure of Implant; Fall; Joint Dislocation

  MAUDE report 20600231 ↗
• InjuryJun 17, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY ON (B)(6) 2022 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED A DISLOCATION OF THE INTERNAL RIGHT HIP PROSTHESIS THAT REQUIRED RE-REVISION SURGERY ON (B)(6) 2022. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19553696 ↗
• InjurySep 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY IN (B)(6) 2022, THE PATIENT FELL AND SUBSEQUENTLY THE OR30 FEMORAL HEAD DISASSOCIATED FROM THE OR3O DM XLPE INSERT 28/44. A REVISION SURGERY HAD TO BE PERFORMED TO EXCHANGE THE OR30 DUAL MOBILITY LINER AND INSERT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 17694597 ↗
• InjuryFeb 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT SUFFERED AN AT HOME DISLOCATION SOME TIME IN NOVEMBER. BUT THE COMPONENT PROBLEM WAS NOT REALIZED UNTIL DECEMBER, SO THE PATIENT WALKED AROUND FOR OVER A MONTH WITH THE INSERT DISLOCATED. A CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2023 AND THE OR3O DM XLPE INSERT 28/44 CAME DISASSOCIATED FROM HEAD. DURING THE CLOSED REDUCTION THE HEAD WAS PULLED OUT OF THE LINER. THE SAME DAY ((B)(6) 2023) A REVISION WAS PERFORMED. THE PATIENT IS IN GOOD HEALTH NOW.

  Patient problems: Joint Dislocation

  MAUDE report 16329673 ↗
• InjuryMay 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2022, THEY NOTICED THAT INCOMPATIBLE IMPLANT SIZES WERE USED SINCE THE STAFF HAD OPENED THE INCORRECT SIZED LINER DURING THE SURGERY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE OR3O DM XLPE INSERT 28/44 ALONG WITH THE OXONIUM FEM HD 12/14 28 MM +0. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489099 ↗
• InjuryAug 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT WENT TO ER WITH A HIP DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH IT WAS CONFIRMED THAT THE HEAD HAD DISASSOCIATED FROM THE INSERT. A SMITH AND NEPHEW BACK UP DEVICE WAS USED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12318978 ↗
• InjurySep 25, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED WITH AN OR3O CONSTRUCT, THE PATIENT SUFFERED A DISLOCATION AS THE HEAD PULLED OUT OF THE INSERT. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE 56 DM INSERT AND THE 28+4 OXINIUM FEMORAL HEAD CAME OUT. THE 56 OXINIUM LINER WAS ALSO EXPLANTED AS THE PATIENT RECEIVED AN R3 SYSTEM INSTEAD OF THE ORIGINAL OR3O SYSTEM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10590310 ↗