OMNI Hip 302800Recalls & reported problems
Omni Life Science, Inc. · Femoral CoCr Head 28 mm +0mm · Class 2 · Implant
All models of OMNI Hip (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841690100355), received between Jan 24, 2018 and Mar 27, 2021 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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, 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
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Hip Fracture2
- No Known Impact Or Consequence To Patient2
- Joint Dislocation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2021Fracture; 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 DATE IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED PERI-PROSTHETIC FRACTURE. DURING THE REVISION, THE ACETABULAR INSERT AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH A NEW DEVICE.
Patient problems: Hip Fracture
MAUDE report 11579890 ↗InjuryJan 7, 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 DATE IS (B)(6) 2010. THE REASON FOR REVISION IS REPORTED CUP LOOSENING. DURING TH REVISION, THE OMNI HEAD WAS REMOVED AND REPLACED WITH NON-OMNI PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9560362 ↗InjuryDec 20, 2019Insufficient 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) 2016. THE REASON FOR REVISION IS REPORTED CUP MAL-POSITIONED. DURING THE REVISION, THE FEMORAL HEAD WAS REMOVED AND REVISED TO A NEW COMPONENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9507166 ↗InjuryJul 3, 2019Insufficient 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) 2019. THE REASON FOR REVISION IS REPORTED PERI-PROSTHETIC FRACTURE. DURING THE REVISION, THE OMNI DISTRIBUTED STEM AND CUP WERE REMOVED AND REPLACED. THE ORIGINAL OMNI FEMORAL HEAD WAS REMOVED AND REPLACED.
Patient problems: Hip Fracture
MAUDE report 8759335 ↗InjuryJan 24, 2018Device Dislodged or Dislocated
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF DISLOCATION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 28 MM FEMORAL HEAD WAS REMOVED AND REPLACED WITH A NEW COMPONENT OF THE SAME SIZE.
Patient problems: Joint Dislocation
MAUDE report 7217023 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
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- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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