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OMNI Hip 302899Recalls & reported problems

Omni Life Science, Inc. · Femoral CoCr Head 28 mm -3.5mm · Class 2 · Implant

All models of OMNI Hip (31)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690100393), received between Jul 13, 2017 and Apr 13, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1
  • Naturally Worn1
  • Unintended Movement1

Patient problems

  • No Code Available2
  • Failure of Implant1
  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2020. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED DISLOCATION LEADING TO DISASSOCIATION OF THE HEAD FROM THE BIPOLAR. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL HEAD AND BIPOLAR HEAD WERE REMOVED AND REPLACED WITH A NEW HEAD, CUP AND INSERT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9954397 ↗
  • InjuryAug 27, 2018Naturally Worn

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2007. THE REVISION SURGERY OCCURRED BECAUSE OF THE REPORTED WEAR OF A NON-OMNI POLY LINER. DURING THE REVISION, THE ORIGINAL NON-OMNI POLY LINER WAS REMOVED DUE TO WEAR AND REPLACED WITH AN APEX-LNK ACETAB INSERT, E/40, 10 DEG HOOD. THE ORIGINAL 28MM X -3.5 COCR FEMORAL HEAD WAS REMOVED AND REPLACED WITH 40MM X -3.5 COCR FEMORAL HEAD TO ACCOMMODATE THE LARGER OMNI ACETABULAR INSERT.

    Patient problems: No Code Available

    MAUDE report 7817853 ↗
  • InjuryJan 12, 2018Unintended Movement

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE SUBSIDENCE. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL HEAD AND SERF SHELL AND INSERT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 7187406 ↗
  • InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL LINER AND FEMORAL HEAD WERE REVISED TO NEW COMPONENTS OF THE SAME SIZE.

    Patient problems: Unspecified Infection

    MAUDE report 6711058 ↗

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

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