OMNI Interface Acetabular System H6-14436Recalls & reported problems
Omni Life Science, Inc. · ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690120315), received between May 25, 2018 and May 25, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (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
- Nonstandard Device2
- Packaging Problem2
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2018Nonstandard Device; Packaging Problem
ON 05/18/2018, OMNI RECEIVED NOTIFICATION FROM A SALES REPRESENTATIVE THROUGH OUR COMPLAINT SYSTEM THAT THE PATIENT STICKERS ATTACHED TO THE PEEL PACK TYVEK POUCH DID NOT MATCH THE OUTER BOX LABELING. THE OUTER BOX INDICATED A 0 DEGREE HOODED INSERT WHILE THE INTERNAL LABELING INDICATED A 10 DEGREE HOODED INSERT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7546307 ↗MalfunctionMay 25, 2018Nonstandard Device; Packaging Problem
ON 05/17/2018, OMNI RECEIVED NOTIFICATION FROM A SALES REPRESENTATIVE THROUGH OUR COMPLAINT SYSTEM THAT THE PATIENT STICKERS ATTACHED TO THE PEEL PACK TYVEK POUCH DID NOT MATCH THE OUTER BOX LABELING. THE OUTER BOX INDICATED A 0 DEGREE HOODED INSERT WHILE THE INTERNAL LABELING INDICATED A 10 DEGREE HOODED INSERT.
Patient problems: No Patient Involvement
MAUDE report 7546302 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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