APEX PS Knee KP-0045LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690112129), received between Jul 3, 2017 and Sep 9, 2025 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY IS DATED (B)(6) 2023. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE FEMUR, TIBIAL TRAY, INSERT AND BOLT WERE REMOVED AND REPLACED WITH A NEW IMPLANTS.

  Patient problems: Aseptic loosening

  MAUDE report 23002863 ↗
• InjuryJul 3, 2017Loose or Intermittent Connection

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF TIBIAL SUBSIDENCE. DURING THE REVISION, ALL ORIGINAL OMNI COMPONENTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT. THE SIZE 4+ FEMORAL COMPONENT, SIZE 4 TIBIAL BASEPLATE, SIZE 4 X 10 MM TIBIAL INSERT AND RETAINING BOLT, AND THE SIZE 32 MM X 8 MM PATELLA WERE REMOVED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6683962 ↗