OMNI ARC HipRecalls & reported problems across all models
Omni Life Science, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls
- 0
We found 10 models of OMNI ARC Hip by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2017 and Sep 23, 2022 — classified as 53 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (24 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported OMNI ARC Hip problems
Device problems
- Insufficient Device Problem Information24
- Appropriate Device Problem Term/Code Not Available17
- Metal Shedding Debris5
- Adverse Event Without Identified Device or Use Problem4
- Device Slipped1
- Material Fragmentation1
- Material Rupture1
- Patient-Device Incompatibility1
Patient problems
- Pain32
- Reaction7
- No Code Available4
- No Known Impact Or Consequence To Patient4
- Autoimmune Reaction2
- Metal Related Pathology2
- Failure of Implant1
- Osteolysis1
OMNI ARC Hip models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OMNI ARC Hip HC-21003-HAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED15 reports
- OMNI ARC Hip HC-21002-HAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED12 reports
- OMNI ARC Hip HC-21001-HAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED10 reports
- OMNI ARC Hip HC-21004-HAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- OMNI ARC Hip HC-22001Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- OMNI ARC Hip HC-22002PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OMNI ARC Hip HC-22004Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- OMNI ARC Hip HC-22003Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI ARC Hip HC-21000-HAProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI ARC Hip HC-24002-HAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent OMNI ARC Hip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED METALLOSIS. DURING THE REVISION, THE STEM, NECK AND HEAD WERE REMOVED AND REPLACED WITH NON-OMNI IMPLANTS.
Patient problems: Metal Related Pathology
MAUDE report 15472741 ↗InjuryNov 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED METALLOSIS. DURING THE REVISION, ALL ORIGINAL COMPONENTS WERE REMOVED AND REPLACED.
Patient problems: Metal Related Pathology
MAUDE report 12760624 ↗InjuryOct 22, 2021Appropriate 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 OCCURRED ON (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK, AND FEMORAL HEAD WERE REMOVED. ALL COMPONENTS WERE REVISED.
Patient problems: Pain
MAUDE report 12682323 ↗InjuryOct 21, 2021Appropriate 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 OCCURRED ON (B)(6) 2014. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK, AND FEMORAL HEAD WERE REMOVED. ALL COMPONENTS WERE REVISED.
Patient problems: Pain
MAUDE report 12677027 ↗InjuryJul 7, 2021Appropriate 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 OCCURRED ON (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK, AND FEMORAL HEAD WERE REMOVED. ALL COMPONENTS WERE REVISED TO NON-OMNI PRODUCT.
Patient problems: Pain
MAUDE report 12130723 ↗InjuryJun 18, 2021Appropriate 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 OCCURRED ON (B)(6) 2012. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK, LINER AND FEMORAL HEAD WERE REMOVED. THE STEM WAS REPLACED WITH CORIN STEM AND HEAD AND AN OMNI CUP AND INSERT.
Patient problems: Pain
MAUDE report 12027152 ↗InjuryFeb 3, 2021Appropriate 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 OCCURRED ON (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK AND FEMORAL HEAD WERE REMOVED. THE STEM WAS REPLACED WITH AN OMNI DISTRIBUTED STEM AND THE HEAD WAS REPLACED WITH A NON-OMNI COMPONENT.
Patient problems: Pain
MAUDE report 11277067 ↗InjuryMay 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2014. THE REASON FOR REVISION IS REPORTED PAIN. DURING THIS REVISION, DR. REMOVED THE ARC STEM, NECK AND HEAD ALL OMNI. HE LEFT THE ZIMMER CUP AND REPLACED THE LINER. HE REPLACED THE ARC STEM WITH A PARAGON STEM AND CERAMIC OMNI HEAD.
Patient problems: Pain
MAUDE report 10038861 ↗InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REASON FOR REVISION IS UNKNOWN. DURING THE REVISION, THE ORIGINAL FEMORAL STEM, MODULAR NECK AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH NON-OMNI COMPONENTS.
Patient problems: No Code Available
MAUDE report 9825895 ↗InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION ALL OMNI PRODUCT WAS REMOVED AND REPLACED WITH NON-OMNI PRODUCT.
Patient problems: Pain
MAUDE report 9812451 ↗InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REASON FOR REVISION IS UNKNOWN. DURING THE REVISION, THE ORIGINAL MODULAR NECK WAS REMOVED AND REPLACED WITH A NEW COMPONENT. IN ADDITION, THE ORIGINAL NON-OMNI HEAD WAS REMOVED AND REPLACED WITH A NEW OMNI FEMORAL HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9696058 ↗InjuryJan 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY OCCURED ON (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL MODULAR NECK AND STEM WERE REMOVED AND REPLACED WITH A NEW MONOCLOCK FEMORAL STEM.
Patient problems: Pain
MAUDE report 9655161 ↗InjuryJan 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2020. THE FIRST REVISION SURGERY OCCURED ON (B)(6) 2016 AND THE ORIGINAL SURGERY OCCURED ON (B)(6) 2010. THE REASON FOR REVISION IS REPORTED PAIN. DURING THIS REVISION, THE ORIGINAL STEM WAS EXPLANTED AND REPLACED WITH NON-OMNI PRODUCT, AND THE NECK IMPLANTED DURING THE FIRST REVISION SURGERY WAS REMOVED AND REPLACED WITHIN-OMNI PRODUCT.
Patient problems: Pain
MAUDE report 9638773 ↗InjuryJan 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REASON FOR REVISION IS REPORTED PAIN. DURING THE REVISION, ALL OMNI COMPONENTS WERE REMOVED AND NON-OMNI PRODUCT WAS IMPLANTED.
Patient problems: Pain
MAUDE report 9582520 ↗InjuryJan 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2010. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL OMNI HIP STEM AND NECK WERE REMOVED AND REPLACED.
Patient problems: Pain
MAUDE report 9582465 ↗
Other Omni Life Science, Inc. products
- OMNI Knee78 models · 476 reports
- APEX PS Knee63 models · 170 reports
- OMNI Hip31 models · 68 reports
- APEX CR Knee28 models · 65 reports
- OMNI K2 Hip5 models · 8 reports · 1 recall
- OMNI Interface Acetabular System22 models · 42 reports
- APEX Knee System30 models · 38 reports
- APEX Revision Knee22 models · 32 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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