OR3O Dual Mobility 71358202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556712238), received between Jun 18, 2020 and Jul 26, 2024 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A PRIMARY THA PROCEDURE PERFORMED ON (B)(6) 2020 DUE TO OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, ONE (1) PATIENT SUSTAINED A HIP INFECTION AT 3-4 POSTOPERATIVE MONTHS THAT REQUIRED A REVISION SURGERY. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 19845904 ↗
• InjuryJul 1, 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 SUFFERED AN UNKNOWN ADVERSE EVENT THAT LED TO A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 14892360 ↗
• InjuryJun 17, 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 14738520 ↗
• 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 10171667 ↗