OMNI HipRecalls & reported problems across all models
Omni Life Science, Inc. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls
- 0
We found 31 models of OMNI Hip by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Aug 17, 2026 — classified as 67 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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
Reports received per month, all models
Most reported OMNI Hip problems
Device problems
- Insufficient Device Problem Information33
- Device Dislodged or Dislocated9
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available8
- Fracture2
- Naturally Worn2
- Unstable2
- Connection Problem1
Patient problems
- Joint Dislocation23
- No Code Available8
- Joint Laxity6
- No Known Impact Or Consequence To Patient6
- Unspecified Infection5
- Pain4
- Failure of Implant3
- Insufficient Information3
OMNI Hip models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OMNI Hip H3-53600Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- OMNI Hip H3-53699Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented8 reports
- OMNI Hip 302800Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- OMNI Hip 302899Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- OMNI Hip H3-53604Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- OMNI Hip 302835Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- OMNI Hip 303200PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- OMNI Hip H3-52800Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- OMNI Hip H3-54008Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- OMNI Hip 302807Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- OMNI Hip 303600PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- OMNI Hip H3-82846Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- OMNI Hip H3-82848Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- OMNI Hip 303210PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OMNI Hip 303635PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OMNI Hip 304007Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip 304035PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- OMNI Hip 332800Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- OMNI Hip 332835Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- OMNI Hip 333235Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip 333600Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-53200Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-53204Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-53608Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-54004Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-54000Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-54099Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OMNI Hip H3-82243Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- OMNI Hip H3-82844Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- OMNI Hip H3-82847Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- OMNI Hip H3-82854Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Recent OMNI Hip adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJan 19, 2026Implant subsidence
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE WAS (B)(6) 2025. THE REASON FOR REVISION REPORTED IS SUBSIDED STEM. DURING THE REVISION A CORIN ICONA STEM, AND AN OMNIHIP FEMORAL HEAD WAS REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24108864 ↗InjuryJul 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE WAS (B)(6) 2022. THE REASON FOR REVISION IS INSTABILITY. DURING THE REVISION THE OMNI HEAD AND MODULAR NECK AS WELL AS TRINITY INSERT AND LINER, WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 19700214 ↗InjuryJun 18, 2024Unstable; Unstable
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE WAS (B)(6) 2023. THE REASON FOR REVISION IS INSTABILITY. DURING THE REVISION THE OMNI HEAD AND MODULAR NECK WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 19559943 ↗InjuryApr 23, 2024Adverse 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) 2024. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED DISLOCATION DUE TO PATIENT FALL. DURING THE SURGERY, THE ORIGINAL FEMORAL HEAD AND LINER WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Joint Dislocation
MAUDE report 19164483 ↗InjuryAug 16, 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 IS DATED (B)(6) 2022. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD AND NECK WAS REVISED WITH A NEW OMNI HEAD.
Patient problems: Joint Dislocation
MAUDE report 17553924 ↗InjuryAug 9, 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 IS DATED (B)(6) 2012. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW OMNI HEAD.
Patient problems: Joint Dislocation
MAUDE report 17495177 ↗InjuryJul 24, 2023Unstable; Unstable
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED ON (B)(6) 2020. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW NON-OMNI IMPLANT.
Patient problems: Joint Dislocation
MAUDE report 17386134 ↗InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW NON-OMNI IMPLANT.
Patient problems: Joint Dislocation
MAUDE report 17075995 ↗InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2022. THE REASON FOR REVISION IS UNKNOWN. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REPLACED FOR NEW COMPONENT.
Patient problems: Insufficient Information
MAUDE report 16851862 ↗InjuryApr 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE WAS (B)(6) 2021. THE REASON FOR REVISION IS INSTABILITY. DURING THE REVISION THE HEAD AND MODULAR NECK WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 16773616 ↗InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE WAS (B)(6) 2018. THE REASON FOR REVISION IS INSTABILITY. DURING THE REVISION THE HEAD AND MODULAR NECK WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 16729187 ↗InjuryOct 24, 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 IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW IMPLANT.
Patient problems: Joint Laxity
MAUDE report 15659211 ↗InjurySep 26, 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) 2011. THE REASON FOR REVISION IS REPORTED METALLOSIS. DURING THE REVISION, THE FEMORAL HEAD AND INSERT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Metal Related Pathology
MAUDE report 15484850 ↗InjuryAug 26, 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 IS DATED (B)(6) 2022. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD AND MODULAR NECK WITH BOLT WERE REPLACED FOR NEW COMPONENTS.
Patient problems: Joint Laxity
MAUDE report 15305170 ↗
Other Omni Life Science, Inc. products
- OMNI Knee78 models · 476 reports
- APEX PS Knee63 models · 170 reports
- APEX CR Knee28 models · 65 reports
- OMNI K2 Hip5 models · 8 reports · 1 recall
- OMNI ARC Hip10 models · 53 reports
- 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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