OMNI Interface Acetabular System H5-54436Recalls & reported problems
Omni Life Science, Inc. · ApeX-LNK Acetabular Insert, UHMWPE 10 degree Hood, D Insert/36mm ID · Class 2 · Implant
All models of OMNI Interface Acetabular System (22)
Data updated Oct 16, 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 00841690120018), received between Jul 3, 2017 and Dec 3, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
Patient problems
- Fall1
- Joint Dislocation1
- Joint Disorder1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WH UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE REVISION, ALL OMNI COMPONENTS WERE REMOVED AND REPLACED WITH NON-OMNI DEVICES.
Patient problems: Joint Dislocation; Joint Disorder
MAUDE report 9403800 ↗InjurySep 21, 2018Insufficient Device Problem Information
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. IT IS UNKNOWN WHY THE REVISION SURGERY OCCRED. DURING THE REVISION, THE OMNI LINER WAS REMOVED AND REPLACED WITH A NON-OMNI LINER.
Patient problems: No Code Available
MAUDE report 7898977 ↗InjuryJul 3, 2017Device 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF POSSIBLE PATIENT FALL AND CUP DISLODGE INTO PROTRUSION. DURING THE REVISION, THE ORIGINAL OMNI ACETABULAR CUP, ACETABULAR INSERT, FEMORAL COMPONENT, FEMORAL HEAD, AND FEMORAL NECK WERE EXPLANTED. A NON-OMNI ACETABULAR CUP AND LINER WERE IMPLANTED, AND THE ORIGINAL SIZE 6 FEMORAL STEM WAS REPLACED WITH A SIZE 7 FEMORAL STEM, THE LONG NECK WAS REPLACED WITH A MEDIUM MODULAR NECK, AND THE 38MM X 0MM FEMORAL HEAD WAS REPLACED WITH A 40MM X +0MM HEAD.
Patient problems: Fall
MAUDE report 6684447 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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