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OMNI ARC Hip HC-21000-HARecalls & reported problems

Omni Life Science, Inc. · ARC Femoral Stem Porous Coated, HA Coated Size 0 · Class 2 · Implant

All models of OMNI ARC Hip (10)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841690119395), received between May 25, 2018 and May 25, 2018 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REASON FOR THIS REVISION SURGERY IS PATIENT PAIN. DURING THE REVISION, THE ORIGINAL OMNI SIZE 0 ARC STEM, ARC NECK, AND 32MM +0 FEMORAL HEAD WERE REMOVED AND REPLACED WITH A SIZE 2 PARAGON STEM, 32MM +0 FEMORAL HEAD, AND A COMPETITOR'S LINER.

    Patient problems: Pain

    MAUDE report 7545019 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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