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APEX CR Knee KC-1125RRecalls & reported problems

Omni Life Science, Inc. · CR Femoral Cemented, 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 00841690100935), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMar 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY IS DATE IS (B)(6) 2020. THE REASON FOR REVISION IS REPORTED FEMORAL LOOSENING. DURING THE REVISION THE FEMUR, INSERT AND LOCKING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Patient problems: Insufficient Information

    MAUDE report 13695043 ↗

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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