Omnifit 2041-2850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540035387), received between Nov 12, 2018 and Feb 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2021Naturally Worn; Naturally Worn

  AS REPORTED: "DR...PERFORMED A LEFT HIP REVISION AT (B)(6) HOSPITAL DUE TO POLY WEAR." SPOKE TO REP: HE REPORTED THAT THE ACETABULAR SHELL WAS REVISED DUE TO POOR POSITIONING. AS THE IMPLANT HAS BEEN IN SITU SINCE 1995, IT IS UNKNOWN IF THE SHELL WAS IMPLANTED IN THAT POSITION OR IF IT MIGRATED. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND EXPLANTS ARE HOSPITAL RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327785 ↗
• InjuryJul 28, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO POLY WEAR. A 10° CUP INSERT AND C-TAPER HEAD WERE EXPLANTED. THE REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.

  Patient problems: Injury

  MAUDE report 10331317 ↗
• InjuryNov 12, 2018Unstable; Unstable

  IT WAS REPORTED, PATIENT HAD LEFT HIP REVISION. HEAD AND LINER EXCHANGE OF SERIES 2 LINER AND C-TAPER HEAD. UPDATE 10/19/2018: THE REASON FOR REVISION WAS AN UNSTABLE HIP.

  Patient problems: Injury

  MAUDE report 8059872 ↗