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APEX Revision Knee KP-0425LRecalls & reported problems

Omni Life Science, Inc. · Revision Femur PS, cemented Size 2+ Left · Class 2 · Implant

All models of APEX Revision Knee (22)

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 00841690112761), received between Apr 15, 2020 and Apr 15, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryApr 15, 2020Loose or Intermittent Connection

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

    Patient problems: No Code Available

    MAUDE report 9964223 ↗

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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