Omnifit 6076-0730ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327023503), received between Aug 22, 2018 and Nov 28, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16, 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.

• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FRACTURE OF THE TROCHANTER, WHICH LED TO DISLOCATION OF THE BIPOLAR HEAD FROM THE PATIENT'S NATIVE ACETABULUM (SURGEON REPORTED CONTRIBUTING FACTORS: NON-COMPLIANT PATIENT, POOR BONE QUALITY). PATIENT WAS CONVERTED TO A TOTAL HIP (STEM WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18222568 ↗
• InjuryAug 22, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A LOOSE STEM. SURGEON REPORTED THE STEM WAS POSITIONING INSIDE THE PATIENT'S FEMUR. PATIENT WAS REVISED TO A COMPETITOR CONSTRUCT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7806901 ↗

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