Omnifit 2041-2854Recalls & reported problems
Howmedica Osteonics Corp. · 10degrees Series II Insert · Class 2 · Implant
All models of Omnifit (43)
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 04546540035394), received between Nov 4, 2020 and May 29, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn2
- Unstable1
Patient problems
- Insufficient Information1
- Joint Laxity1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ECENTRIC WEAR OF THE LINER. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information
MAUDE report 22108596 ↗InjuryJan 12, 2021Naturally Worn; Naturally Worn
AS REPORTED: "PATIENTS RIGHT HIP: HEAD, CUP AND LINER WERE REVIVED DUE TO POLY WEAR." A SECUR-FIT HA SHELL, C-TAPER CERAMIC HEAD, AND OMNIFIT 10° INSERT WERE REVISED. PATIENT WAS REVISED TO A TRITANIUM CONSTRUCT WITH MDM LINER.
Patient problems: No Information
MAUDE report 11153265 ↗InjuryNov 4, 2020Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. AN OSTEONICS MORSE TAPER HEAD AND 10° OSTEONICS INSERT WERE REVISED TO A CONSTRAINED LINER AND NEW FEMORAL HEAD. REP PROVIDED A PORTION OF THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.
Patient problems: Joint Laxity
MAUDE report 10783636 ↗
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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