OMNI K2 Hip 130002Recalls & reported problems

Omni Life Science, Inc. · K2 Femoral Stem, Size 2 · Class 2 · Implant

All models of OMNI K2 Hip (5)

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 00841690102458), received between Mar 23, 2017 and Mar 8, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 Available1
Device Operates Differently Than Expected1
Insufficient Device Problem Information1

Patient problems

Osteolysis2
Autoimmune Reaction1
Unequal Limb Length1

Recent adverse event reports

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

InjuryMar 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2017. REASON FOR REVISION IS PATIENT LEG LENGTH DISCREPANCY. DURING THIS REVISION THE STEM, NECK, ACETABULAR INSERT AND HEAD WERE REMOVED. A NEW OMNI ACETABULAR INSERT WAS IMPLANTED.
Patient problems: Unequal Limb Length
MAUDE report 13694198 ↗
InjuryJun 3, 2017Appropriate Device Problem Term/Code Not Available
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2009. THE REVISION SURGERY OCCURRED BECAUSE OF METALOSIS AND SECONDARY OSTEOLYSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 K2 STEM, MEDIUM 37.5 NEUTRAL NECK, AND BIOLOX CERAMIC HEAD WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.
Patient problems: Autoimmune Reaction; Osteolysis
MAUDE report 6610253 ↗
InjuryMar 23, 2017Device Operates Differently Than Expected
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2009. THE REVISION SURGERY OCCURRED BECAUSE OF OSTEOLYSIS. DURING THE REVISION, THE ORIGINAL SIZE 2 K2 STEM, MEDIUM 37.5 NEUTRAL NECK, AND CERAMIC FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW NON-OMNI PRODUCT. THE ORIGINAL SHELL AND LINER WERE NON-OMNI PRODUCTS.
Patient problems: Osteolysis
MAUDE report 6429766 ↗

Device details

UDI-DI	`00841690102458`
Brand	OMNI K2 Hip
Model	130002
Company	Omni Life Science, Inc.
Product code	LPH · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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.

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

PINNACLE 1217-25-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
735 reports
NA 1365-52-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
683 reports
APEX 1246-03-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 deaths613 reports
PINNACLE 1217-20-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
2 deaths590 reports
PINNACLE 1217-30-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
1 death484 reports
NA 1365-53-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
404 reports
PINNACLE ALTRX 1221-36-054
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
388 reports
PINNACLE ALTRX 1221-32-050
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
386 reports

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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