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APEX CR Knee KC-1420RRecalls & reported problems

Omni Life Science, Inc. · CR Femoral Uncemented, Size 2 Right · Class 2 · Implant

All models of APEX CR Knee (28)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841690104209), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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.

Most reported problems

Device problems

  • Unstable1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 21, 2018Unstable

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 RIGHT CR FEMORAL COMPONENT, SIZE 2 X 12MM ULTRA INSERT, AND TIBIAL BASEPLATE RETAINING BOLT, WERE REMOVED AND REPLACED WITH A SIZE 2 RIGHT PS FEMORAL COMPONENT, SIZE 2 X 16MM PS-C INSERT, AND A 16MM PS-C TIBIAL BASEPLATE RETAINING BOLT.

    Patient problems: Failure of Implant

    MAUDE report 7898987 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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