APEX Revision Knee KP-24118Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690113898), received between Aug 27, 2018 and Jun 4, 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 4, 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 DATE WAS (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH LARGER COMPONENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118804 ↗
• InjuryAug 27, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 1 LEFT PS REVISION FEMORAL COMPONENT, SIZE 1 X 18MM PS-R INSERT, SIZE 3 MODULAR TIBIAL BASEPLATE, SIZE 17MM X 100MM REVISION STEM, REVISION TIBIAL PEG, AND 18MM PS-R RETAINING BOLT WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817831 ↗