OMNI Mod Hip 151306Recalls & reported problems

Omni Life Science, Inc. · OMNI Modular Stem Size 6, 13mm · Class 2 · Implant

All models of OMNI Mod Hip (18)

Data updated Oct 16, 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 00841690102748), received between Mar 24, 2022 and Feb 14, 2023 — classified as 3 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 16, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Appropriate Device Problem Term/Code Not Available1
Device Dislodged or Dislocated1
Insufficient Device Problem Information1

Patient problems

Fall1
Insufficient Information1
Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE IS ON (B)(6) 2023. THE REASON FOR REVISION IS REPORTED PATIENT FALL THAT RESULTED IN PERI-PROSTHETIC FRACTURE DURING THE REVISION STEM AND MODULAR NECK WERE REMOVED AND REPLACED WITH NEW DEVICES.
Patient problems: Fall
MAUDE report 16375655 ↗
InjuryAug 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY OCCURRED IN (B)(6) 2022. THE SURGERY OCCURRED BECAUSE OF REPORTED INFECTION DURING THE REVISION STEM AND MODULAR NECK AND HEAD WERE REMOVED AND REPLACED WITH NEW DEVICES.
Patient problems: Unspecified Infection
MAUDE report 15298789 ↗
InjuryMar 24, 2022Device 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) 2022. THE ORIGINAL SURGERY DATE WAS (B)(6) 2022. THE REASON FOR REVISION REPORTED IS SUBSIDED STEM. DURING THE REVISION A STEM, MODULAR NECK AND FEMORAL HEAD WAS REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 13873778 ↗

Device details

UDI-DI	`00841690102748`
Brand	OMNI Mod Hip
Model	151306
Company	Omni Life Science, Inc.
Product code	MEH · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 2021

Device type (GMDN): Coated hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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CORAIL 3L92511
Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
158 reports
Acumatch A Series 138-36-29
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
3 recalls1 report
Novation 136-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls43 reports
Novation 130-32-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls33 reports
Novation 132-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls26 reports
Novation 136-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls22 reports

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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