OR3O Dual Mobility 71358214Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556712344), received between Jun 18, 2020 and Jun 17, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED (INSERT ACETABULAR OR3O XLPE OD 38 MM ID22 MM 2 MOBILITY AND LINER ACETABULAR OR3O OD 50 MM ID38 MM 2 MOBILITY) WITH COMPETITORS FEMORAL HEAD AND STEM (ZIMMER); PATIENT SUSTAINED AN INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL RIGHT HIP PROSTHESIS THAT REQUIRED RE-REVISION SURGERY ON (B)(6) 2020. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19554075 ↗
• InjuryJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED A DISLOCATION OF THE INTERNAL LEFT HIP PROSTHESIS THAT REQUIRED RE-REVISION SURGERY ON (B)(6) 2020. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19553679 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A DISLOCATION THAT LED TO A REVISION SURGERY ON (B)(6) 2022, WHERE THE OR3O DM XLPE INSERT WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15126951 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A RIGHT THR REVISION PERFORMED ON (B)(6) 2022 DUE TO RECURRENT DISLOCATIONS, THE PATIENT EXPERIENCED AN ADDITIONAL DISLOCATION AND UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2022. DURING THIS PROCEDURE, THE SURGEON USED A POSTEROLATERAL APPROACH TO ACCESS THE HIP JOINT AND NOTICED THAT THE XLPE INSERT HAD SEPARATED FROM THE OXINIUM LINER. THE FEMORAL HEAD, THE OXINIUM LINER, THE XLPE INSERT AND THE R3 ACETABULAR CUP WERE EXPLANTED AND REPLACED WITH A WIDER ACETABULAR SHELL, A CONSTRAINED LINER AND A NEW FEMORAL HEAD. THE PATIENT'S CURRENT HEALTH STATUS IS NOT KNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14714640 ↗
• MalfunctionNov 12, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DUAL MOBILITY INSERT (71358214) HAD THE INCORRECT CHART-LABEL STICKER IN THE BOX. THE STICKER THAT WAS PULLED OUT WAS FOR PRODUCT 71358202- THE COMPATIBLE LINER. FAULT IN LABELING WAS NOTICED DURING SET UP OR INSPECTION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10832563 ↗
• InjuryJun 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, AFTER A OR3O SYSTEM HAD BEEN IMPLANTED IN A THR SURGERY, THE PATIENT PRESENTED A DISLOCATED DUAL MOBILITY PROSTHESIS. A CLOSED REDUCTION WAS PERFORMED TO ALLEVIATE THE PROBLEM; HOWEVER, UPON OBTAINING X-RAYS, ECCENTRICITIES WERE DISCOVERED BETWEEN THE SHELL AND THE FEMORAL NECK ON THE STEM, WHICH WAS ALSO CONFIRMED WITH A CT SCAN, SO THE PATIENT WAS SCHEDULED FOR REVISION SURGERY THE NEXT DAY. DURING THE REVISION SURGERY, THE SHELL WAS FOUND TO BE WELL FIXED. THE STEM WAS ALSO WELL FIXED WITH THE FEMORAL HEAD STILL ATTACHED TO THE MORSE TAPER. THE DUAL MOBILITY PLASTIC BEARING WAS DETACHED FROM THE FEMORAL HEAD AND WAS NOT INSIDE THE DUAL MOBILITY LINER. THE SURGEON (I) REMOVED BOTH THE CUP AND CEMENTED STEM AND PLACED A 4MM LARGER R3 CUP (54MM) IN A MORE ANTEVERTED POSITION; (II) DOWNSIZED THE STEM WHILE CONVERTING TO A HIGH OFFSET IMPLANT, PLACING IT IN A MORE SUPERIOR POSITION; AND (III) CHOSE TO USE AGAIN AN OR3O DUAL MOBILITY IMPLANT WITH THIS CONSTRUCT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10171677 ↗