OMNI Mod Hip 230410Recalls & reported problems
Omni Life Science, Inc. · Modular Neck Neutral Anteversion, Medium 47.5 · Class 2 · Implant
All models of OMNI Mod Hip (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690102953), received between Dec 11, 2018 and Feb 3, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY IS DATED (B)(6) 2010. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD AND MODULAR NECK WERE REPLACED FOR NEW COMPONENTS.
Patient problems: Joint Dislocation
MAUDE report 11277063 ↗InjuryDec 11, 2018Appropriate Device Problem Term/Code Not Available
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2010. THE REVISION SURGERY OCCURRED BECAUSE OF SUSPECTED METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI MODULAR NECK AND STEM WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.
Patient problems: No Code Available
MAUDE report 8150167 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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