OMNI Hip 302835Recalls & 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690100386), received between Mar 25, 2020 and Aug 17, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
- Fall1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Patient Device Interaction Problem
A complaint was initiated for a patient who underwent a bilateral hip revision surgery on (b)(6) 2026. The original surgery date was (b)(6) 2018 and (b)(6) 2017. The reason for revision is wear. During the revision the OMNI heads were removed and replaced with new implants.
Patient problems: Failure of Implant
MAUDE report 50273450 ↗InjuryOct 5, 2021Fracture
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED PATIENT FALL THAT RESULTED IN PERI-PROSTHETIC FRACTURE OF AN OMNI DISTRIBUTED STEM. DURING THE REVISION, THE STEM, ACETABULAR INSERT AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW DEVICES.
Patient problems: Fall
MAUDE report 12579561 ↗InjuryMar 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND HIP REVISION SURGERY ON (B)(6)2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2020 AND THE FIRST REVISION OCCURRED (B)(6) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THIS REVISION, THE COCR FEMORAL HEAD AND THE SHELL LINER WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.
Patient problems: Unspecified Infection
MAUDE report 9880342 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
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- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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