OR3O Dual Mobility 71353319Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556710616), received between Jul 9, 2021 and Apr 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. WHEN THE SURGEON DISSECTED DOWN, SOON REALIZED THAT THE OR3O DUAL MOBILITY TRIAL INSERT 28/44 FROM THE PREVIOUS SURGERY WAS LEFT IN THE PATIENT. THE TRIAL WAS REMOVED ALONG WITH THE REAL IMPLANTED STEM, HEAD AND INSERT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018418 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED, THAT DURING INSPECTION A REAMER HANDLE, OR3O DUAL MOBILITY TRIAL INSERT 28/44 AND OR3O DUAL MOBILITY TRIAL INSERT 28/50, WERE BROKEN AND NEED TO BE REPLACED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144374 ↗