Omnifit 6076-0830ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327023572), received between Mar 30, 2021 and May 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031744); they may or may not involve this specific model.

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.

• InjuryMay 26, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. SURGEON'S ORIGINAL PLAN WAS TO CONVERT THE PATIENT'S HEMI HIP TO A TOTAL HIP BY REVISING THE UNIPOLAR COMPONENT. HOWEVER, WHEN HE TAPPED ON THE COMPONENT, THE STEM CAME OUT OF THE PATIENT'S FEMUR. ALL COMPONENTS WERE REVISED WITH STRYKER ACETABULAR COMPONENTS AND COMPETITOR FEMORAL COMPONENTS.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17011849 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE CAUSED BY A FALL. A 46 X 28 UHR UNIVERSAL HEAD BIPOLAR COMPONENT, 28+0MM C-TAPER LFIT HEAD, AND SIZE 8 ONMIFIT STEM WERE REVISED TO A UHR UNIVERSAL HEAD BIPOLAR COMPONENT OF THE SAME SIZE WITH A 28 -4MM CERAMIC V40 HEAD AND A RESTORATION MODULAR HIP SYSTEM. THERE ARE NO ALLEGATIONS AGAINST THE HEAD OR BIPOLAR COMPONENT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11590255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031744. One submission often covers many models, so check the product and lot details in each record.

• Z-0896-2009 · Nov 13, 2008 · Terminated
  Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or