APEX PS Knee KP-20411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690113225), received between Jun 22, 2018 and Jun 3, 2020 — classified as 2 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.

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.

• InjuryJun 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT FALL. PATIENT WAS REVISED DUE LOOSE TIBIA - PATIENT WAS RUNNING AND HAD A FALL. ALL IMPLANTS EXCEPT THE PATELLA WERE REMOVED

  Patient problems: Fall

  MAUDE report 10114326 ↗
• InjuryJun 22, 2018Naturally Worn

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED WEAR. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X11MM PS INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 4X14MM PS INSERT AND RETAINING BOLT.

  Patient problems: Failure of Implant

  MAUDE report 7630863 ↗