APEX PS Knee KP-22412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690113652), received between Aug 27, 2018 and Oct 24, 2019 — 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.

• InjuryOct 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9235945 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 12MM PS-C INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7817801 ↗