APEX PS Knee KP-0025RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690112051), received between Feb 22, 2017 and Nov 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY AND LOOSENING. DURING THE REVISION ALL OF THE IMPLANTS WERE REMOVED AND REPLACED WITH A NEW IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 18117469 ↗
• InjuryNov 12, 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) 2017. THE REASON FOR REVISION IS REPORTED ASEPTIC LOOSENING. DURING THE REVISION, THE ORIGINAL FEMORAL COMPONENT, RETAINING BOLT, TIBIAL INSERT AND TIBIAL BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, DURING THE REVISION, TWO REVISION STEMS, THREE FEMORAL AUGMENTS, THREE FEMORAL AUGMENT BOLTS, AND A TIBIAL AUGMENT AND BOLT WERE ADDED.

  Patient problems: No Code Available

  MAUDE report 9312440 ↗
• InjuryFeb 22, 2017Unstable; Device Operates Differently Than Expected

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE AND POOR LCL LIGAMENT. DURING THE REVISION, THE ORIGINAL FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, LOCKING BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6350255 ↗