OMNI ARC Hip HC-22001Recalls & reported problems
Omni Life Science, Inc. · ARC Neck, Neutral Short · Class 2 · Implant
All models of OMNI ARC Hip (10)
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 00841690115908), received between Oct 12, 2017 and Feb 11, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 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 ↗InjuryOct 12, 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) 2010. DURING THE REVISION, THE ORIGINAL NON-OMNI FEMORAL HEAD AND SHELL WERE REMOVED AND REPLACED WITH A NEW OMNI FEMORAL HEAD AND NON-OMNI SHELL. IN ADDITION, THE ORIGINAL OMNI FEMORAL NECK WAS REMOVED AND REPLACED WITH A NEW OMNI NECK.
Patient problems: No Code Available
MAUDE report 6945601 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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