APEX Revision Knee KP-24116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690113881), received between Feb 23, 2017 and Sep 12, 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.

• InjurySep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2019. THE FIRST REVISION OCCURED ON (B)(6) 2016. THE ORIGINAL SURGERY IS UNKNOWN. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THIS REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 9012333 ↗
• InjuryFeb 23, 2017Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2017. THE FIRST REVISION SURGERY IS DATED (B)(6) 2015. THIS REVISION SURGERY OCCURRED BECAUSE OF ANTERIOR KNEE PAIN. DURING THE REVISION, THE ORIGINAL SIZE 1 X 16MM INSERT AND RETAINING BOLT WERE REVISED TO SIZE 1 X 18MM INSERT AND RETAINING BOLT. DURING THE SURGERY, A PATELLAR COMPONENT WAS ALSO ADDED AS A CREPITUS WAS FOUND ON THE PATELLA.

  Patient problems: Pain

  MAUDE report 6352733 ↗