OR3O Dual Mobility 71358216Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556712351), received between Oct 14, 2020 and Jan 9, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A DISLOCATION. UPON RELOCATION, THE OR3O DM XLPE INSERT 22/40 WAS DISASSOCIATED FROM INNER HEAD. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16016598 ↗
• InjuryDec 24, 2020Dent in Material; Dent in Material

  IT WAS REPORTED THAT, DURING A THR SURGERY, UPON IMPACTING THE DUAL-MOBILITY HEAD IT DENTED THE POLYETHYLENE PLASTIC INSERT. SURGEON WAS NOT COMFORTABLE USING THAT IMPLANT. IT IS UNKNOWN HOW THE PROCEDURE FINISHED AND IF THERE WAS A SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072305 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY, THE PATIENT'S WOUND WAS NOT CLEARING UP. THE PATIENT HAD A WASHOUT AND AN INSERT EXCHANGE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 10681479 ↗