APEX CR Knee KC-1460LRecalls & reported problems
Omni Life Science, Inc. · CR Femoral Uncemented, Size 6 Left · Class 2 · Implant
All models of APEX CR Knee (28)
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 00841690104353), received between Aug 31, 2017 and Nov 22, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Failure of Implant1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION ALL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 20757504 ↗InjuryOct 3, 2018Unstable
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 6 LEFT CR FEMORAL COMPONENT, SIZE 6 LEFT TIBIAL TRAY, 38MM X 8MM PATELLA DOME, SIZE 6 X 14MM ULTRA INSERT, AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCTS.
Patient problems: Failure of Implant
MAUDE report 7931764 ↗InjuryAug 31, 2017Insufficient Device Problem Information
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THE REVISION, THE FEMORAL COMPONENT, TIBIAL INSERT, AND BOLT WERE REMOVED. ALL COMPONENTS WERE REVISED TO NEW IMPLANTS.
Patient problems: Pain
MAUDE report 6836683 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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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